Non‐pharmacological interventions for treating chronic prostatitis/chronic pelvic pain syndrome

Juan VA Franco; Tarek Turk; Jae Hung Jung; Yu‐Tian Xiao; Stanislav Iakhno; Virginia Garrote; Valeria Vietto

doi:10.1002/14651858.CD012551.pub3

Cochrane Database Syst Rev. 2018; 2018(5): CD012551.

Published online 2018 May 12. doi: 10.1002/14651858.CD012551.pub3

PMCID: PMC6494451

PMID: 29757454

Non‐pharmacological interventions for treating chronic prostatitis/chronic pelvic pain syndrome

Monitoring Editor: Juan VA Franco, Tarek Turk, Jae Hung Jung, Yu‐Tian Xiao, Stanislav Iakhno, Virginia Garrote, Valeria Vietto, and Cochrane Urology Group

Instituto Universitario Hospital Italiano, Argentine Cochrane Centre, Potosí 4234, Buenos AiresBuenos AiresArgentina, C1199ACL

Hospital Italiano de Buenos Aires, Family and Community Medicine Service, Tte. Gral. Juan Domingo Perón 4190, Buenos AiresBuenos AiresArgentina, C1199ABB

Damascus University, Faculty of Medicine, Mazzeh Street, DamascusSyrian Arab Republic

Yonsei University Wonju College of Medicine, Department of Urology, 20 Ilsan‐ro, WonjuGangwonKorea, South, 26426

Yonsei University Wonju College of Medicine, Institute of Evidence Based Medicine, 20 Ilsan‐ro, WonjuGangwonKorea, South, 26426

Changhai Hospital, Second Military Medical University, Department of Urology, 168 Changhai Road, ShanghaiChina

University of Tromso, 9020, Storbakkvegen 21, TromsdalenNorway, H0101

Instituto Universitario Hospital Italiano, Biblioteca Central, J.D. Perón 4190, Buenos AiresArgentina, C1199ABB

Juan VA Franco, Email: ra.gro.onailatilatipsoh@ocnarf.nauj, Email: moc.liamg@58favj.

Author information Copyright and License information PMC Disclaimer

Abstract

Background

Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is a common disorder in which the two main clinical features are pelvic pain and lower urinary tract symptoms. There are currently many approaches for its management, using both pharmacological and non‐pharmacological interventions. The National Institute of Health ‐ Chronic Prostatitis Symptom Index (NIH‐CPSI) score is a validated measure commonly used to measure CP/CPPS symptoms.

Objectives

To assess the effects of non‐pharmacological therapies for chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS).

Search methods

We performed a comprehensive search using multiple databases, trial registries, grey literature and conference proceedings with no restrictions on the language of publication or publication status. The date of the latest search of all databases was August 2017.

Selection criteria

We included randomised controlled trials. Inclusion criteria were men with a diagnosis of CP/CPPS. We included all available non‐pharmacological interventions.

Data collection and analysis

Two review authors independently classified studies and abstracted data from the included studies, performed statistical analyses and rated quality of evidence (QoE) according to the GRADE methods.

Main results

We included 38 unique studies with 3290 men with CP/CPPS across 23 comparisons.

1. Acupuncture: (three studies, 204 participants) based on short‐term follow‐up, acupuncture probably leads to clinically meaningful reduction in prostatitis symptoms compared with sham procedure (mean difference (MD) in total NIH‐CPSI score ‐5.79, 95% confidence interval (CI) ‐7.32 to ‐4.26, high QoE). Acupuncture may result in little to no difference in adverse events (low QoE). Acupuncture may not reduce sexual dysfunction when compared with sham procedure (MD in the International Index of Erectile Function (IIEF) Scale ‐0.50, 95% CI ‐3.46 to 2.46, low QoE). Acupuncture may also lead to a clinically meaningful reduction in prostatitis symptoms compared with standard medical therapy (MD ‐6.05, 95% CI ‐7.87 to ‐4.24, two studies, 78 participants, low QoE). We found no information regarding quality of life, depression or anxiety.

2. Lifestyle modifications: (one study, 100 participants) based on short‐term follow‐up, lifestyle modifications may be associated with a reduction in prostatitis symptoms compared with control (risk ratio (RR) for improvement in NIH‐CPSI scores 3.90, 95% CI 2.20 to 6.92, very low QoE). We found no information regarding adverse events, sexual dysfunction, quality of life, depression or anxiety.

3. Physical activity: (one study, 85 participants) based on short‐term follow‐up, a physical activity programme may cause a small reduction in prostatitis symptoms compared with control (NIH‐CPSI score MD ‐2.50, 95% CI ‐4.69 to ‐0.31, low QoE). This programme may not reduce anxiety or depression (low QoE). We found no information regarding adverse events, sexual dysfunction or quality of life.

4. Prostatic massage: (two studies, 115 participants) based on short‐term follow‐up, we are uncertain whether the prostatic massage reduces or increases prostatitis symptoms compared with control (very low QoE). We found no information regarding adverse events, sexual dysfunction, quality of life, depression or anxiety.

5. Extracorporeal shockwave therapy: (three studies, 157 participants) based on short‐term follow‐up, extracorporeal shockwave therapy reduces prostatitis symptoms compared with control (NIH‐CPSI score MD ‐6.18, 95% CI ‐7.46 to ‐4.89, high QoE). These results may not be sustained at medium‐term follow‐up (low QoE). This treatment may not be associated with a greater incidence of adverse events (low QoE). This treatment probably improves sexual dysfunction (MD in the IIEF Scale MD 3.34, 95% CI 2.68 to 4.00, one study, 60 participants, moderate QoE). We found no information regarding quality of life, depression or anxiety.

6. Transrectal thermotherapy compared to medical therapy: (two studies, 237 participants) based on short‐term follow‐up, transrectal thermotherapy alone or in combination with medical therapy may decrease prostatitis symptoms slightly when compared with medical therapy alone (NIH‐CPSI score MD ‐2.50, 95% CI ‐3.82 to ‐1.18, low QoE). One included study reported that participants may experience transient adverse events. We found no information regarding sexual dysfunction, quality of life, depression or anxiety.

7. Other interventions: there is uncertainty about the effects of most of the other interventions included in this review. We found no information regarding psychological support or prostatic surgery.

Authors' conclusions

Based on the findings of moderate quality evidence, this review found that some non‐pharmacological interventions such as acupuncture and extracorporeal shockwave therapy are likely to result in a decrease in prostatitis symptoms and may not be associated with a greater incidence of adverse event. The QoE for most other comparisons was predominantly low. Future clinical trials should include a full report of their methods including adequate masking, consistent assessment of all patient‐important outcomes including potential treatment‐related adverse events and appropriate sample sizes.

Plain language summary

Intervention for treating chronic prostatitis and chronic pelvic pain in men

Review question

What are the effects of non‐medicine therapies in men with longstanding pain and discomfort around their prostate and pelvis, so‐called chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS)?

Background

CP/CPPS is a common disorder in which men feel pelvic pain or have bothersome symptoms (or both of these) when urinating. Its cause is unknown and there are many different treatments for this condition.

Study characteristics

The evidence was current to August 2017. We found 38 studies that were conducted between 1993 and 2016 with 3187 participants that made 23 comparisons between different treatments in men with CP/CPPS. The evaluated interventions usually implied the use of devices, medical advice or some form of physical therapy. In many cases, these therapies were given to men in an outpatient setting. Most studies did not specify their funding sources; three studies reported funding from device makers.

Key results

Acupuncture: we found that acupuncture (an alternative medicine where thin needles are inserted into the skin at specific points) probably causes a significant decrease in symptoms of prostatitis and may not associated with side effects when compared with pretend acupuncture, however, it may not reduce sexual problems. It probably decreases symptoms when compared with standard medical therapy. We found no information on its effect on quality of life, depression or anxiety.

Lifestyle modifications: we are uncertain whether the recommendation of lifestyle modifications reduces symptoms when compared to the continuation of the same lifestyle. We had no information regarding side effects, sexual problems, quality of life, depression or anxiety.

Physical activity: we found that a physical activity programme may reduce symptoms (small effect) when compared with a non‐specific activity used as a control, however it may not reduce anxiety or depression. We have no information regarding side effects, sexual problems or quality of life.

Prostatic massage: we are uncertain whether the prostatic massage reduces or increases symptoms when compared with no massage. We found no information regarding side effects, sexual problems, quality of life, depression or anxiety.

Extracorporeal shockwave therapy: we found that extracorporeal shockwave therapy (where shock waves are passed through the skin to the prostate) causes a significant decrease in symptoms compared to a simulated procedure. These results may not be lasting after more continued treatment. This treatment may not be associated with side effects. We have no information regarding quality of life, depression or anxiety.

Transrectal thermotherapy compared to medical therapy: we found that transrectal thermotherapy (which applies heat to the prostate and pelvic muscle area) alone or in combination with medical therapy may cause a small decrease in symptoms compared to medical therapy alone. One of the included studies reported that participants may experience transient side effects. We have no information regarding sexual problems, quality of life, depression or anxiety.

There is uncertainty about the effects of other interventions.

Quality of the evidence

The quality of the evidence was low in most cases, meaning that there is much uncertainty surrounding the results. The included studies were not well designed, had a small sample size and had a short follow‐up time (usually 12 weeks).

Summary of findings

Background

Description of the condition

Prostatitis is a common disorder affecting 10% to 14% of men in Europe and the USA (Bajpayee 2012). This health problem motivates 1% of primary care visits and 8% of urology consultations in the USA (Collins 1998). Only 5% to 10% of prostatitis cases have a bacterial origin (Bartoletti 2007; De La Rosette 1993). This disorder can affect men of all ages and ethnic origins, but it is more common in younger men with a mean age of onset at 42 years old (Schaeffer 2002). The two main clinical features of prostatitis are pelvic pain and lower urinary tract symptoms (LUTS), even though there is a wide range of clinical presentations (Nickel 1999a).

The National Institutes of Health (NIH) classification identifies four types of prostatitis (Nickel 1999a): type I, acute bacterial prostatitis; type II, chronic bacterial prostatitis; type III, chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) and type IV, asymptomatic prostatitis. It remains unclear whether type III can be linked in all cases to prostatic involvement (True 1999), thus the alternate denomination (CPPS). CP/CPPS is subclassified as type IIIa, inflammatory, and type IIIb, non‐inflammatory, depending on the presence of inflammatory cells in prostatic secretions. Before this classification, this entity was denominated chronic abacterial or non‐bacterial prostatitis (similar to type IIIa CP/CPPS) and prostatodynia (similar to type IIIb CP/CPPS) (Krieger 1996). This change in the classification might have changed the epidemiology of this condition (Krieger 2004).

CP/CPPS is defined when pelvic pain is present for at least three of the preceding six months and no other identifiable causes have been detected (Nickel 1999a). Other symptoms include obstructive or irritative voiding difficulties, ejaculatory pain, and haematospermia. Men affected by CP/CPPS have a significantly decreased quality of life (QoL) and the level of pelvic pain is strongly associated with sexual dysfunction (Trinchieri 2007; Walz 2007). CP/CPPS is associated with other functional somatic syndromes, such as irritable bowel syndrome, interstitial cystitis, chronic fatigue syndrome and fibromyalgia (Rodriguez 2009; Suskind 2013). Diagnosis is usually based on patient history, physical examination, urinalysis and the two‐ or four‐glass test (Nickel 2012). Further investigations are performed when considering differential diagnosis.

There are different theories regarding the aetiology and pathophysiology of CP/CPPS, as follows.

Infection: bacterial DNA is detected in a significant proportion of men with CP/CPPS (Hou 2012). A previous history of sexually transmitted infection is more frequent in men with CP/CPPS (Pontari 2005). Nevertheless, the isolation of uropathogenic bacteria in prostatic fluids is similar to controls (Nickel 2003a).
Inflammation/autoimmunity: elevated concentrations of proinflammatory cytokines (interleukin 1, tumour necrosis factor, interferon‐γ) and of autoimmunity activity (T‐cell proliferation responses to prostate antigens) is found in men with CP/CPPS and in animal models (Pontari 2004).
Neuropsychological factors: the central nervous system might be involved through several mechanisms of pain sensitisation (Miller 2002; Yang 2003). Increased stress burden, stress response, pain catastrophising cognitions, poor social functioning and psychiatric comorbidity (anxiety and depression) are contributing factors (Riegel 2014).
Dyssynergic voiding associated with bladder neck hypertrophy is detected in men with refractory CP/CPPS (Dellabella 2006; Hruz 2003). Intraprostatic urinary reflux and increased intraprostatic pressure is associated with inflammation in CP/CPPS (Kirby 1982; Mehik 2002).
Other theories described for this condition include: adrenal axis abnormalities (Anderson 2008), pelvic floor muscles dysfunction (Hetrick 2006; Shoskes 2008a), pelvic nerve entrapment (Antolak 2002), genetic predisposition to inflammation (Shoskes 2002), and oxidative stress (Arisan 2006).

Description of the intervention

There is a wide variety of interventions for treating CP/CPPS, each one addressing a different pathophysiological or symptomatic framework. The diversity of available interventions reflects the complexity of the condition and how little is known about its determinants.

Management of CP/CPPS involves a multimodal and tailored approach (Rees 2015; Shoskes 2008b). Some of the strategies used alone or in combination are the following.

Pharmacological interventions

Alpha‐blockers.
5‐alpha reductase inhibitors.
Antibiotic therapy (quinolones, tetracyclines and other agents).
Analgesics (non‐steroidal anti‐inflammatory drugs (NSAIDs), pregabalin).
Phytotherapy (pollen extract and bioflavonoids).
Botulinum toxin A.
Allopurinol.
Traditional medicine (traditional Chinese medicine, etc.).
Other pharmacological agents.

Non‐pharmacological interventions

Acupuncture and electroacupuncture.
Local thermotherapy.
Extracorporeal shockwave therapy.
Electromagnetic chair.
Myofascial trigger point release.
Biofeedback.
Circumcision.
Lifestyle interventions.
Physical activity.
Psychological support.
Prostatic surgery.
Other miscellaneous non‐pharmacological therapies.

Multimodal approaches

Combination therapy: alpha blockers plus antibiotics, antibiotics plus analgesics, etc.

Adverse events

Common adverse effects of pharmacological regimens include the following (Brunton 2011).

Alpha‐blockers: hypotension, ejaculatory dysfunction, headache, dizziness and nasal congestion.
5‐alpha‐reductase inhibitors: decreased libido, impotency, and potentiation of hypotension (in combination with alpha‐blockers).
Quinolones: gastrointestinal discomfort, headache, dizziness, rash and tendinopathy.
Tetracyclines: gastrointestinal discomfort, rash, teeth discolouration and hepatotoxicity.
NSAIDs: peripheral oedema, rash, dyspepsia, peptic ulcer and bleeding, renal and hepatic injury, and increased risk of adverse cardiovascular events.
Phytotherapy: gastrointestinal discomfort and allergic reactions.

The most common adverse effect in physical therapies is pain worsened during or immediately after the procedure (Fitzgerald 2013).

Clinical phenotyping

Clinical phenotyping is a strategy that was developed to deliver customised treatment in an aetiological framework (Shoskes 2008b). The UPOINT system addresses six domains: Urinary symptoms, Psychosocial dysfunction, Organ‐specific findings, Infection, Neurological dysfunction and Tenderness of muscles, and offers an algorithmic approach for the use of the various available interventions. The number of affected domains holds a significant correlation with the prostatitis symptoms score and the addition of a Sexual dysfunction domain (UPOINT(S)) improves accuracy in stratification of symptom severity (Magri 2010). While in itself it is not an intervention, it serves as a screening tool to select the most appropriate intervention for each patient.

How the intervention might work

Pharmacological interventions

Alpha‐blockers reduce the autonomic sympathetic tone in the bladder neck and prostate, improving urinary flow and LUTS. 5‐alpha‐reductase inhibitors reduce the production of dihydrotestosterone and, consequently, the size of the prostatic gland dependent on the stimulation of this hormone. This might reduce pain and impaired voiding (Brunton 2011).

NSAIDs are antagonists to the cyclo‐oxygenases (COX) enzymes type 1 and 2 and their proinflammatory subproducts (Brunton 2011). Both non‐selective and selective (COX‐2) inhibitors could therefore decrease inflammatory mediated pain in CP/CPPS.

Phytotherapy includes the use of pollen extract and bioflavonoids that appear to have anti‐inflammatory properties, decreasing acinar cell proliferation and the production of interleukin‐6, tumour necrosis factor α, and other proinflammatory cytokines (Capodice 2005; Kamijo 2001).

Even if CP/CPPS is defined when no bacterial cause can be identified, antibiotics have been used to treat it under the assumption of the existence of an occult or undertreated infection (Hou 2012).

Allopurinol would reduce the prostatic secretions of purine and pyrimidine base‐containing metabolites in urine. These metabolites could be responsible for prostatic inflammation through urinary reflux (McNaughton 2002).

Botulinum toxin A has denervating properties and causes reduction in pain mediators when applied to the prostate in animal models. It also causes apoptosis and involution of the prostate gland (Chuang 2006).

Non‐pharmacological interventions

Acupuncture targets specific cutaneous points representing various internal organs using fine needle insertion and sometimes adding electric current to increase stimulation (electroacupuncture). In animal models, electroacupuncture has anti‐inflammatory properties and activates analgesic neurotransmitters (Kim 2006).

Locally induced hyperthermia, using transrectal or transurethral procedures, could decrease oxygen free radicals associated with prostatic inflammation (Gao 2012).

Myofascial trigger point release targets pelvic floor musculature dysfunction as a potential cause or contributor to CP/CPPS (Fitzgerald 2013). Biofeedback also addresses pelvic floor muscle through initial contraction to achieve further relaxation (Capodice 2005).

Extracorporeal shockwave therapy could promote vascularisation of the prostatic tissue and modulate nociceptive nerve impulses and pelvic floor tone (Pajovic 2016).

The length of the foreskin is positively associated with the presence of symptoms of CP/CPPS; therefore, it has been proposed that circumcision could reduce prostatitis symptoms (Zhao 2015).

There are certain risk factors in the lifestyle of men with CP/CPPS, including alcohol consumption and smoking status, among others, that are associated with worse clinical outcomes. Interventions aimed at reducing those risk factors, including those aimed at increasing physical activity, could reduce prostatitis symptoms (Chen 2016).

Prostatic massage has been a classical treatment for CP/CPPS aimed at relieving prostatic congestion, although the mechanisms for its therapeutic effects are controversial (Nickel 1999b).

It has been suggested that psychological treatments could be helpful in all types of chronic pain syndromes and the psychiatric comorbidity associated with the condition (e.g. depression secondary to chronic pain) (Riegel 2014).

Why it is important to do this review

The Cochrane Urology Group undertook an extensive prioritisation exercise to identify a core portfolio of the most clinically important titles. Consequently, this title was identified as a clinically important priority by the urology expert panel for development, maintenance and investment of resources by the editorial base.

CP/CPPS is a prevalent condition among men and it causes significant impairment of QoL. There was a previous Cochrane Review on the same subject but with a different methodological approach (McNaughton 2000). Other non‐Cochrane systematic reviews were also undertaken in previous years: some of them focused on individual interventions (Qin 2016a; Yang 2006; Zhu 2014), while others had a wider scope of interventions (Anothaisintawee 2011; Cohen 2012; Magistro 2016). We consider that a new and updated Cochrane Review is needed to critically summarise the body of evidence for this complex condition using the GRADE approach, thus providing key information about the best estimate of the magnitude of the effect in relative terms and absolute differences for patient‐important outcomes. Previous systematic reviews did not use this approach and had variable adherence to the rigorous methodology recommended by Cochrane.

The protocol for this review was first published in August 2016 with the title 'Interventions for treating chronic prostatitis/chronic pelvic pain syndrome' (Franco 2016). Due to the retrieval of a significant amount of included studies, the review team and the Cochrane Urology Group decided to split the review in two more narrowly defined reviews: 'Non‐pharmacological interventions for treating chronic prostatitis/chronic pelvic pain syndrome' and 'Pharmacological interventions for treating chronic prostatitis/chronic pelvic pain syndrome' (Franco 2017).

Objectives

To assess the effects of non‐pharmacological therapies for chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS).

Methods

Criteria for considering studies for this review

Types of studies

We included randomised controlled trials (RCTs) regardless of their publication status or language of publication.

Types of participants

We included men of all ages, regardless of social condition or ethnic origin, with CP/CPPS according with type III prostatitis of the NIH classification.

If we identified studies in which only a subset of participants was relevant to this review, we included such studies if data were available separately for the relevant subset.

Types of interventions

We investigated the following comparisons of experimental intervention versus comparator intervention. Concomitant interventions had to be the same in the experimental and comparator groups to establish fair comparisons. We performed a condition‐based comprehensive bibliographic search to find all interventions tested so far for CP/CPPS; therefore, some of them might not be listed in this section.

Non‐pharmacological interventions

Acupuncture and electroacupuncture.
Circumcision.
Electromagnetic chair.
Lifestyle interventions.
Physical activity.
Prostatic massage.
Extracorporeal shockwave therapy.
Local thermotherapy (transurethral, transrectal thermotherapy and external).
Biofeedback.
Myofascial trigger point release.
Laser therapy.
Tibial nerve stimulation.
Myofascial therapy.
Osteopathy.
Sono‐electromagnetic therapy.
Transelectrical nerve stimulation
Transurethral needle ablation.
Non‐intrusive ultrasound.
Psychological support.
Prostatic surgery.
Other miscellaneous non‐pharmacological therapies.

Multimodal approaches

Combination of pharmacological and non‐pharmacological therapy: acupuncture plus antibiotics, local thermotherapy plus alpha‐blockers, etc.
Combination of non‐pharmacological therapies.

Comparator interventions

Placebo or sham procedure.
No treatment.
Other types of interventions: pharmacological and non‐pharmacological.

Comparisons

We performed head‐to‐head comparisons or intervention versus placebo or sham procedure/no treatment comparisons.

We did not include studies evaluating only pharmacological interventions to avoid overlapping with the review 'Pharmacological interventions for treating chronic prostatitis/chronic pelvic pain syndrome' (Franco 2017).

Types of outcome measures

We did not use the measurement of the outcomes assessed in this review as an eligibility criterion.

Primary outcomes

Prostatitis symptoms.
Adverse events.

Secondary outcomes

Sexual dysfunction.
Urinary symptoms.
Quality of life (QoL).
Depression and anxiety.

Method and timing of outcome measurement

We used clinically important difference for the review outcomes to rate overall quality of the evidence in 'Summary of finding' tables (Johnston 2010). When the mean difference (MD) or risk ratio (RR) was equal to or larger than the minimal clinically important difference (MCID), we assumed that many participants may have gained clinically meaningful improvement from treatment; when the MD was at least half of the MCID but less than the MCID, an appreciable number of participants had likely achieved a clinically meaningful improvement; and when the MD was less than one‐half of the MCID, it was unlikely that an appreciable number of participants achieved clinically meaningful improvement (Johnston 2010).

Prostatitis symptoms

Measured by the National Institutes of Health ‐ Chronic Prostatitis Symptom Index (NIH‐CPSI) as total score and subscore measurements, when possible, and other validated scales.
We considered an MCID in NIH‐CPSI score as a 25% decrease or a 6‐point reduction from baseline (Nickel 2003b). This threshold was used to measure the 'responders rate' (Cates 2015).

Adverse events

Defined as treatment intolerance, adverse effects of the interventions at any time after participants were randomised to intervention/comparator groups.
There was no established threshold for adverse events. We considered the clinically important differences of adverse events above as relative risk reduction of at least 25% (Guyatt 2011a).

Sexual dysfunction

Measured by validated scales (e.g. International Index of Erectile Function, IIEF).
We considered the MCID in the erectile function domain score of the IIEF of four (Rosen 2011). We planned to use different thresholds of MCID based on the severity of erectile dysfunction, with a threshold of two for men with mild erectile dysfunction, five with moderate erectile dysfunction and seven with severe erectile dysfunction (Rosen 2011). We also considered IIEF‐5 of over five points as the MCID (Spaliviero 2010).

Urinary symptoms

Measured by IPSS (International Prostate Symptom Score) or AUASS (American Urological Association Symptom Score).
We considered improvement of the IPSS score of three points as an MCID to assess efficacy and comparative effectiveness (Barry 1995). We planned to use different thresholds of MCID based on the severity of IPSS, with a threshold of three for men with mild LUTS, five for moderate LUTS and eight for severe LUTS (Barry 1995).

Quality of life

Assessed by the Medical Outcomes Study Short Form 12 (SF‐12) or other validated scales.
We considered an MCID of SF‐12 physical component score to be 8 and SF‐12 mental component score to be 4 (Parker 2013).

Depression and anxiety

Assessed by Beck Depression Inventory, State Anxiety Inventory‐Y or other validated scales.
We considered an MCID of Beck Depression Inventory to be 11 and State Anxiety Inventory‐Y to be 10 (Button 2015; Corsaletti 2014).

We considered outcomes measured up to and including 12 months after randomisation as short‐term, and later than 12 months as long‐term.

Main outcomes for 'Summary of findings' tables

We presented 'Summary of findings' tables reporting the following outcomes listed according to priority.

Prostatitis symptoms.
Adverse events.
Sexual dysfunction.
QoL.
Depression and anxiety.

Search methods for identification of studies

We searched for all published and unpublished RCTs meeting our stated inclusion/exclusion criteria, without restrictions on language, publication date or publication status, and in consultation with the Cochrane Urology Information Specialist.

Electronic searches

We identified published, unpublished and ongoing studies by searching the following databases from their inception.

Cochrane Central Register of Controlled Trials (CENTRAL; 2017, Issue 7) in the Cochrane Library.
PubMed (1946 to 11 August 2017).
Embase Elsevier (1947 to 11 August 2017).
PsycINFO Ovid (1887 to 11 August 2017).
CINAHL EBSCO (1937 to 11 August 2017).
ClinicalTrials.gov (www.clinicaltrials.gov, 14 August 2017)
ISRCTN Registry (BioMed Central; www.isrctn.com/, 14 August 2017).
World Health Organization International Clinical Trials Registry Platform (www.who.int/trialsearch, 14 August 2017).

The search strategies for databases were modelled on the search strategy designed for PubMed (Appendix 1; Appendix 2; Appendix 3; Appendix 4; Appendix 5; Appendix 6). The PubMed search utilised the Cochrane Highly Sensitive Search Strategy for identifying RCTs in MEDLINE: sensitivity maximising version (2008 revision; Lefebvre 2011). The Embase search utilised the trial filter for therapy, maximising sensitivity developed by the Health Information Research Unit (HIRU) at McMaster University, adapted from Ovid to the Elsevier interface (HIRU 2015). For CENTRAL and clinical trials registries, filters were not applicable. We did not use filters for PsycINFO and CINAHL because the results likely to be obtained were very few.

Searching other resources

We tried to identify other potentially eligible trials or ancillary publications by searching the reference lists of retrieved included trials and relevant reviews, meta‐analyses and health technology assessment reports. We contacted authors of included studies to identify any further studies that we may have missed. We contacted drug and device manufacturers for ongoing or unpublished trials. We searched abstract proceedings of the American Urological Association, European Association of Urology and Society of Sexual Medicine from 2015 to 2017 for unpublished studies (Appendix 7).

We searched other grey literature sources such as:

Open Grey (www.opengrey.eu/);
New York Academy of Medicine Grey Literature Report (www.greylit.org/);
Google Scholar.

Data collection and analysis

Selection of studies

We used reference management software (EndNote) and Covidence to identify and remove duplicate records. Three review authors (JVAF, TT, VV) independently scanned in pairs the abstract, title, or both, of remaining records retrieved, to determine which studies should be assessed further. Five review authors (JVAF, TT, SI, YX, VV) investigated all potentially relevant records as full text, mapped records to studies, and classified studies as included studies, excluded studies, studies awaiting classification or ongoing studies in accordance with the criteria for each provided in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011a). We used Covidence for title/abstract, and full‐text screening. We resolved any discrepancies through consensus or recourse to a third review author (JHJ). If resolution of a disagreement was not possible, we designated the study as 'awaiting classification' (Characteristics of studies awaiting classification) and we contacted study authors for clarification. We documented reasons for exclusion of studies that may have reasonably been expected to be included in the review in a Characteristics of excluded studies table. We presented an adapted PRISMA flow diagram showing the process of study selection (Liberati 2009).

Data extraction and management

We developed a dedicated data abstraction form that we pilot tested ahead of time.

For studies that fulfilled inclusion criteria, six review authors (JVAF, VV, TT, SI, YX, JHJ) independently abstracted in pairs the following information, which is provided in the Characteristics of included studies table.

Study design.
Study dates (if dates were not available then this was reported as such).
Study settings and country.
Participant inclusion and exclusion criteria.
Participant details, baseline demographics.
Number of participants by study and by study arm.
Details of relevant experimental and comparator interventions such as dose, route, frequency and duration.
Definitions of relevant outcomes, and method and timing of outcome measurement as well as any relevant subgroups.
Study funding sources.
Declarations of interest by primary investigators.

We further summarised some of the characteristics of the studies, participants and interventions in additional tables (Table 11; Table 12).

1

Description of interventions

Study ID	Intervention(s) (route, frequency, total dose/day)	Intervention(s) appropriate as applied in a clinical practice setting (description)	Intervention(s) duration	Comparator(s) (route, frequency, total dose/day)	Comparator(s) appropriate as applied in a clinical practice setting (description)	Comparator(s) duration
Neimark 2016	Breathing exercises using 'Karbonik' apparatus (hypercapnic hypoxia) 10‐20 min daily + medical therapy (see comparison).	No information regarding dose‐scaling or contraindications.	10 days.	Levofloxacin 500 mg/day, tamsulosin 0.4 mg/day, Samprost daily suppository, Serenoa repens fructuum extract 1 capsule/day for 10 days, nimesulide 1‐2 tablets/day for 5‐7 days.	No information regarding dose‐scaling or contraindications.	10 days.
Pajovic 2016	ESWT + medical therapy: each session had 12‐min duration and 3000 impulses with total energy flow 0.25 mJ/mm² 3 Hz, weekly in supine position without anaesthesia.	No information regarding dose‐scaling or contraindications.	12 weeks.	Medical therapy with doxazosin 4 mg daily, ibuprofen 400 mg daily and tiocolchicoside 12 mg daily.	Ranitidine was allowed for gastric complaints. No information regarding dose‐scaling or contraindications.	12 weeks.
Kucuk 2015	Acupuncture group: UB28 bladder meridian GB41 gallbladder meridian LIV3 liver 3 meridian LI4 large intestine 4 meridian SP6 spleen 6 meridian SP8 spleen 8 meridian Stimulation using disposable acupuncture needles (Hua Long, 25 40 mm Sterile Acupuncture Needles, China) and electrical pulse generator (Agistim Duo, 4 4 mA rms max/ 99 Hz max, France).	No information regarding dose‐scaling. "Localized skin infections concerning the acupoints, bleeding diathesis and use of anticoagulation" were contraindications.	7 weeks.	Medical therapy levofloxacin 500 mg daily and ibuprofen 200 mg.	Orally administrated twice daily for 7 weeks. No information regarding dose‐scaling or contraindications.	7 weeks.
Sahin 2015	Acupuncture, using 2 disposable stainless steel needles (0.3 mm diameter, 60 mm length, Suzhou, Jiangsu, China) that were inserted to a depth of maximum 2.5‐3 cm in 7 acupoints bilaterally: BL33 Zhongliao BL34 Xialiao BL54 Zhibian CV1 Huiyin CV4 Guanyuan SP6 Sanyinjiao SP9 Yinlingquan. Duration: 20 min (with rotation).	Applied weekly for 6 weeks without other treatment modalities. No information regarding dose‐scaling or contraindications.	6 weeks.	Punctures in sham group performed 1 cm left of each selected acupoint, with same type of needles, of the same duration and frequency.	Applied weekly for 6 weeks. No information regarding dose‐scaling or contraindications.	6 weeks.
Zhao 2015	Medical therapy (4 weeks of ciprofloxacin 500 mg bid, 3 months of ibuprofen 400 mg/day, 3 months of tamsulosin 0.4 mg/day) and scheduled for surgery during the same period in each of the sites by study clinicians; given written instructions about postoperative wound care.	No information regarding dose‐scaling or contraindications.	3 months.	Same medications (4 weeks of ciprofloxacin 500 mg bid, 3 months of ibuprofen 400 mg/day, 3 months of tamsulosin 0.4 mg/day) and remain uncircumcised until end of 3‐month study participation, when they were scheduled to undergo circumcision.	No information regarding dose‐scaling or contraindications.	3 months.
Gallo 2014	Individually discussed risk factors detected at history by the completed questionnaire, informed that such risk factors were potential causes of their disease symptoms and it was strongly recommended to avoid them, distributed a vademecum with 13 rules relating to diet, sexual habits and lifestyle.	No information regarding dose‐scaling or contraindications.	3 months.	Followed same diet, sexual behaviours and lifestyle as those of the previous months.	No information regarding dose‐scaling or contraindications.	3 months.
Kessler 2014	Sono‐electromagnetic therapy at home using Sonodyn Device: intensity 100 mW/cm² with ultrasonic power of 12 mW and frequency 1.9 MHz, electric field force 0.3 V/m and magnetic field force 0.4 A/m; for 10 min, twice daily.	Participants could not see settings or perceive the device. No information regarding dose‐scaling or contraindications.	12 weeks.	Similar placebo device. Participants applied same procedure, but device was not active during session.	Participants could not see settings or perceive device. No information regarding dose‐scaling or contraindications.	12 weeks.
Kaikai 2014	Non‐intrusive ultrasound. Output frequency 1.79 MHz; output power: 3.15 W/cm². Duration: 20 min, administered every 3 days (total of 7 times) + integrated Chinese‐Western medications.	No information regarding dose‐scaling or contraindications.	‐	Integrated Chinese‐Western medications alone; QianLieShuTong Capsule, orally 3 times daily, 3 capsules each time, tamsulosin delayed‐release capsule, 0.2 mg, orally 4 times daily.	No information regarding dose‐scaling or contraindications.	1 month.
Vahdatpour 2013	ESWT (DUOLITH SD1, Storz Medical, Tägerwilen, Switzerland) once weekly for 4 weeks. Each time 3000 impulses, with 0.25 mJ/mm² and 3 Hz of frequency were delivered, although 0.5 mJ/mm² was added in each week (0.3 mJ/mm² in week 2, 0.35 mJ/mm² in week 3 and 0.4 mJ/mm² in week 4). After each 500 pulses, probe position was corrected, using transperineal ultrasound.	No information regarding dose‐scaling or contraindications.	4 weeks.	In sham group, same protocol applied but with probe being turned off.	No information regarding dose‐scaling or contraindications.	4 weeks.
Fitzgerald 2013	10 × 1‐hour sessions of myofascial physical therapy involved connective tissue manipulation of the abdominal wall, back, buttocks and thighs with connective tissue abnormalities in prone and supine position; double voiding and squatting (as home exercises); transrectal manipulation.	No information regarding dose‐scaling. "The presence of painful scars on lower abdominal wall that according to the health care personnel were unlikely to respond to physical therapy" was used as an exclusion criterion.	‐	10 × 1‐hour sessions of global therapeutic Western massage, including effleurage, petrissage, friction, tapotement, vibration and kneading, in upper and lower limbs, trunk, buttocks, abdomen, head and neck each for prescribed time periods; participants not provided with home exercise programme.	No information regarding dose‐scaling or contraindications.	‐
Zeng 2012	20,000 ESWT (HB‐ESWT‐01, Haibin Medical Equipment Co. Ltd., China) impulses in 10 sessions, applied directly to perineal area in which pain was localised (from anus to scrotum); starting energy density was 0.06 mJ/mm² and frequency of 2 Hz was used for all treatments.	Energy density gradually increased until it reached the maximum possible tolerable pain level reported by participant (recorded and used in all subsequent sessions). No information regarding contraindications.	2 weeks.	Sham ESWT, which was conducted by setting the energy level to 0 (no shockwave energy transmission), under conditions identical to active treatment group.	No information regarding dose‐scaling or contraindications.	2 weeks.
Gao 2012	60‐min treatment with TRFH (ZRL‐II‐A cavity intervention treatment instrument provided by Shanghai Songhang Industry, Co. Ltd. (Shanghai, China), temperature 40‐43 °C) every day.	No information regarding dose‐scaling or contraindications.	5 days.	Tamsulosin 0.2 mg once daily + clarithromycin 0.25 g bid.	No information regarding dose‐scaling or contraindications.	6 weeks.
Gao 2012	TRFH + tamsulosin + clarithromycin (6 weeks).	No information regarding dose‐scaling or contraindications.	5 days.	Tamsulosin 0.2 mg once daily + clarithromycin 0.25 g bid.	No information regarding dose‐scaling or contraindications.	6 weeks.
Yang 2011	Biofeedback group, participant displayed the electromyography of pelvic floor muscle and was instructed to contract and relax the anus according to instructions on display (20‐min sessions, 5 times weekly for 2 weeks).	No information regarding dose‐scaling or contraindications. All participants received interventions in comparison group.	2 weeks.	All participants, including those in the "usual care group" instructed to avoid alcohol and spicy food, sitting too long and holding urine, catching a cold. Advised to be physically active and do exercise, have sex regularly, have warm sitz baths.	They were instructed to discontinue antibiotics, alpha‐blockers and other medications during the trial. No information regarding dose‐scaling or contraindications.	‐
	Electrical stimulation group, anal electrodes using intensity of 6˜23 mA, for 10˜20 s and relaxation for 10˜20 s, (20‐min sessions; 5 times each week for 2 weeks).
	Biofeedback + electrical stimulation (factorial design).
Zhang 2011a	Taijiquan (Tai Chi) exercises for 20‐40 min every day. All participants received herbal therapy (no further specifications available) for 1 month after.	No information regarding dose‐scaling or contraindications.	1 month.	All participants received herbal therapy (no further specifications available) for 1 month after.	No information regarding dose‐scaling or contraindications.	1 month.
Samhan 2011	TENS daily for mean of 20 min in painful area, mean frequency 100 Hz, pulse width 100 μs and intensity 25 mA daily, 5 times weekly.	No information regarding dose‐scaling or contraindications.	1 month.	Same as active treatment group but with machine turned off.	No information regarding dose‐scaling or contraindications.	1 month.
Lee 2009	Advice of hot sitz baths and exercise and 12 × 20‐min sessions of electroacupuncture in 6 weeks: 6 acupoints at bilateral: BL32 zhongliao BL33 ciliao GB30 huantiao; preparation alcohol pads and disposable stainless steel needles (40 0.25 mm, Dongbang Acupuncture, Chungnam, Republic of Korea); at GB30, disposable stainless steel needles (70 0.30 mm, Dongbang Acupuncture) were inserted deeply to reach the myofascial trigger point of piriformis muscle.	No information regarding dose‐scaling or contraindications.	6 weeks.	Advice and exercise and 12 sessions of sham electroacupuncture, which included the same number and type of needle, duration and frequency of sessions as for the advice and exercise treatment, but treatment was delivered superficially at non‐acupoints 15 mm to the lateral of each corresponding acupoint; points were not stimulated electrically, but sound of pulse generator was heard by the participants.	No information regarding dose‐scaling or contraindications.	6 weeks.
Chen 2009	Acupuncture + warm needle moxibustion. Acupuncture at acupoints: BI18 GanYu BI23 ShenYu BI54 ZhiBian BI26 GuanYuan Ren3 ZhongJi SP9 YinLingQuan SP6 SanYinJiao For 5 s each; needles were removed afterwards; once daily for 1 month.	For those treated with moxibustion: needles were left afterwards and the tails of which were then covered with 2 cm moxa sticks. Moxa sticks were then ignited. Repeated moxibustion twice more for each acupoint. No information regarding dose‐scaling or contraindications.	1 month.	Prostat tablet orally twice daily: pollen extract. Course of treatment; 1 month.	No information regarding dose‐scaling or contraindications.	1 month.
Chen 2009	Acupuncture procedures same as acupuncture + warm needle moxibustion. Moxibustion not performed. Treated once daily. Course of treatment: 1 month.		1 month.		No information regarding dose‐scaling or contraindications.	1 month.
Zimmermann 2009	Perineally applied ESWT weekly (3000 pulses each; maximum total energy flow density: 0.25 mJ/mm²; frequency: 3 Hz); position of transducer was changed after every 500 pulses to scan prostatic and pelvic floor region (Duolith SD1, Storz Medical, Tägerwilen, Switzerland); penetration depth 35‐65 mm.	No information regarding dose‐scaling or contraindications.	4 weeks.	Placebo treatment performed with same therapy head, which was also fitted with a placebo stand‐off. Stand‐off contained shock wave‐absorbing material, layer of air and air‐filled microspheres.	No information regarding dose‐scaling or contraindications.	4 weeks.
Marx 2009	Osteopathic theory of structural dysfunction using direct and indirect techniques of manipulation; including rectal manipulation of the prostate and coccyx; 45‐min sessions for 5 weeks.	No information regarding dose‐scaling or contraindications.	5 weeks.	Sham exercise program including a warm‐up, stretching, limb, breathing and pelvic floor muscle exercises; 30 min sessions in 5 weeks.	No information regarding dose‐scaling or contraindications.	5 weeks.
Oh 2009	'Radiofrequency.'	(abstract only)	‐	"Placebo therapy."	(abstract only)	‐
Kabay 2009	PTNS applied unilaterally with 26‐gauge stainless steel needles inserted 5 cm cephalad from medial malleolus and posterior to edge of tibia with a ground neutral electrode placed on same leg near arch of foot; both connected to a stimulator at 200 µs with pulse rate 20 Hz (Medtronic Key Point Net, Medtronic), for 30 min.	No information regarding dose‐scaling or contraindications.	12 weeks.	Same electrode procedure for PTNS; however, stimulator not connected.	No information regarding dose‐scaling or contraindications.	12 weeks.
Yoo 2009	TRMT alone for 12 weeks; using a Uro‐DR Device (Somang Medical; Kangreung, Korea), at intrarectal temperature of 43 °C for 30 min, at a medium heating rate.	No information regarding dose‐scaling or contraindications.	12 weeks.	Medical therapy: ciprofloxacin 500 mg bid and NSAIDs C: TRMT + medical therapy.	No information regarding dose‐scaling or contraindications.	12 weeks.
Lee 2008	4 acupoints prepared, then sterile, disposable stainless steel needles (Suzhou Huan‐Qiu Acupuncture Medical Supplies, Suzhou, China) placed perpendicularly in 30‐min sessions twice weekly in acupoints: CV1 Guan Yuan CV4 Huiyin SP6 Sanyinjiao SP9 Yinlingquan.	No information regarding dose‐scaling or contraindications.	10 weeks.	Sham acupuncture included same number, duration and frequency of sessions as acupuncture group at non‐acupoints (15 mm to left).	No information regarding dose‐scaling or contraindications.	10 weeks.
Sikiru 2008	Antibiotics plus TENS; with high TENS over painful area, daily for mean of 20 min, mean frequency 100 Hz, pulse width 100 μs and intensity 25 mA, 5 times weekly.	Contraindications: loss of skin sensation at and around painful area, cardiac pace maker, previous exposure to TENS and other electroanalgesia.	4 weeks.	Ofloxacin 300 mg 3 times daily + placebo tablets.	No information regarding dose‐scaling or contraindication.	4 weeks.
Giubilei 2007	Aerobic exercise group, which included an 18‐week walking programme, 3 times weekly; with a warm up and cool‐down regimen, postural muscle and isometric strengthening exercises, 40 min of fast‐paced walking on 'in‐outdoor' track (achieving 70/80% of predicted maximum heart rate for their age).	Participants with a 'lack of interest,' 'lack of time' and 'lack of confidence' to engage physical activity excluded from study. No information regarding dose‐scaling.	18 weeks.	Placebo/flexibility and motion exercise programme; with same period and with same frequency of aerobic exercise group, maintaining their heart rate under 100 beats per min.	Participants with a 'lack of interest,' 'lack of time' and 'lack of confidence' to engage physical activity were excluded from the study. No information regarding dose‐scaling.	18 weeks.
Paick 2006	Extracorporeal magnetic innervation using Neoconrol system (Neotonus Inc., Marietta, GA, USA) that generates a magnetic field directed in the seat of chair and concentrated in region of pelvic muscles; 2 sessions weekly lasting 20 min each.	1st 10 min used 10 Hz field, 2 min rest and then 10 min of 50 Hz field. No information regarding contraindications.	6 weeks.	Medical therapy with terazosin 4 mg daily.	They started 2 mg daily for 1st 7 days, and continued to receive 4 mg daily for the following 5 weeks. No information regarding contraindications.	6 weeks.
Ateya 2006	Participants received antibiotics empirically and prostatic massage (3 times weekly for 4 weeks). Prostate massaged from above and lateral to gland, 6 times on each side, by gentle and firm pressure of finger directed downwards and inwards, followed by a few strokes in middle from above downwards.	No information regarding dose‐scaling or contraindications.	‐	Empirical antibiotic therapy alone without prostatic massage.	'In the 44 participants with negative cultures, antibiotic selection included quinolones (28 participants), clindamycin/metronidazole (11 participants), ampicillin/ clavulanic acid (2 participants), and azithromycin (1 participant). All participants continued the 1 month of treatment.'	‐
Shen 2006	Medical therapy with modified BiXieFenQing Drink in morning and evening, 200 mL each + prostate massage once weekly.	No information regarding dose‐scaling or contraindications.	‐	Medical therapy alone.	No information regarding dose‐scaling or contraindications.	‐
Rowe 2005	Participant seated in a Neotonus Electromagnetic Chair (Neotonus Inc., Marietta, GA, USA), for 2 consecutive 15‐min periods; 2 sessions weekly.	1st period 10 Hz, 2nd period 50 Hz. No information regarding contraindications.	4 weeks.	Participants seated in chair, ventilation mechanism activated, but no active stimulation applied.	No information regarding dose‐scaling or contraindications.	4 weeks.
Fang 2005	He‐Ne laser directed to prostate. Optic fibre was inserted from urethra and located at prostatic urethra; 10 mW output at 18 J each time.	1 course of treatment: 10 doses of radiation (2 sessions weekly). Participants discontinued all other treatments, except for some of the participants, short‐term sulfa‐drugs were administered temporarily to prevent infection.	‐	'Routine care' for prostatitis including antibiotics, pollen extract, Chinese medicine, physical therapy and lifestyle interventions.	Sulfamethoxazole tablets, 2 tablets, orally bid, 60 days of fluoroquinolones such as levofloxacin 0.2 g, bid, 14 days of pollen drugs such as Prostat; Chinese patent drugs such as salvianolic acid B and saponins of panax notoginseng mixture (SalB/PNS); hot water bath and advise on lifestyle.	‐
Kastner 2004	Transurethral microwave thermotherapy through catheter connected to a Targis System estimated peak intraprostatic temperatures of 55 °C.	No information regarding dose‐scaling or contraindications.	‐	Transurethral microwave thermotherapy through catheter connected to a Targis System estimated peak intraprostatic temperatures of 70 °C.	No information regarding dose‐scaling or contraindications.	‐
Wang 2002	External radiofrequency hyperthermia.	Applied externally: 2 electrodes placed at hip and lower abdomen, 5˜7 cm away from skin, with pubic symphysis as centre (42.5˜43.5 °C), 1˜2 hours each time, course of treatment: 2˜3 times, interval: 1˜2 weeks. No information regarding dose‐scaling or contraindications.	1˜2 weeks.	Same external radiofrequency hyperthermia + terazosin 2 mg.	Daily for 2 days and then dose was increased to 2 mg bid for 12 weeks. No information regarding contraindications for terazosin.	12 weeks.
Leskinen 2002	TUNA using 465‐kHz radiofrequency energy and formal needle insertion technique as described by Issa 1996; treatment applied on 2 planes on both lateral lobes of prostate in all participants so target temperature of 50 °C at needle tip was achieved for ≥ 1 min; under spinal analgesia and antibiotic prophylaxis.	No information regarding dose‐scaling or contraindications.	‐	3 sham urethroscopy performed so it was seemingly identical to TUNA in participant's opinion; under spinal analgesia and antibiotic prophylaxis.	No information regarding dose‐scaling or contraindications.	‐
Vassily 1999	TRMT, 6 sessions over 2 weeks each.	No information regarding dose‐scaling or contraindications.	‐	Sham procedure.	No information regarding dose‐scaling or contraindications.	‐
Nickel 1996	Transurethral microwave thermotherapy consisted of 1 × 1‐hour treatment with computer‐driven device that elevated prostate interstitial temperatures to 45‐60 °C, a range that does not cause significant necrosis of normal prostatic tissue.	No information regarding dose‐scaling or contraindications.	Single session.	Sham therapy consisted of 1 × 1‐hour session with same device using sham software.	No information regarding dose‐scaling or contraindications.	Single session.
Muraro 1995	Seaprose S (Flaminase, Formenti) 30 mg 3 times daily in combination with local hyperthermia, total of 7 sessions on alternate days of 60‐min duration, reaching local temperature of 42.5‐43.5 °C.	No information regarding dose‐scaling. Contraindication to those with hypersensitivity to the drug.	‐	7 sessions of local hyperthermia alone.	No information regarding dose‐scaling or contraindications.	‐
Montorsi 1993	I1: 1 session of transrectal hyperthermia weekly for 4 weeks. I2: 1 session of transrectal hyperthermia weekly for 6 weeks. I3: 2 sessions of transrectal hyperthermia weekly for 3 weeks. Prostathermer 99D system (Biodan Ltd, Rehovot, Israel), target temperature reached within 1st 10 min of treatment, microwaves at 915 MHz, thermosensors for monitoring rectal temperature, cooling system for anterior rectal wall, thermosensors for urethra temperatures, outpatient basis, required local anaesthesia, with 2% xylocaine jelly before insertion of the catheter.
Shah 1993	TRMT, 4 × 1‐hour treatment over 2 or 3 weeks. Temperature raised to 43.8 °C with input of 40 W.	No information regarding dose‐scaling or contraindications. (abstract only)	2˜3 weeks	Sham group with temperature < 37 °C.	No information regarding dose‐scaling or contraindications. (abstract only)	‐

Study ID	Intervention(s) and comparator(s)	Randomised (n)	Analysed (n)	Duration of intervention and follow‐up	Description of participants^a	Baseline NIH‐CPSI^b score	Trial period (year to year)	Country	Setting
Neimark 2016	I: hypercapnic hypoxia + medical therapy	17	17	D: 10 days F: 10 days	Age: mean 37 No specified previous treatment	N/A	N/A	Russia	Outpatient
	C: medical therapy	20	20
Pajovic 2016	I: extracorporeal shockwave therapy + medical care	30	30	D: 12 weeks F: 24 weeks	Age: mean 39.4 No specified previous treatment	29.3	2013‐2015	Montenegro	Outpatient
	C: medical care	30	30			31.06
Kucuk 2015	I: acupuncture	28	28	D: 7 weeks F: 10 weeks	Age: mean 33 No previous treatment	20.36	2008‐2009	Turkey	Outpatient
	C: medical care	26	26			22.92
Sahin 2015	I: acupuncture	50	45	D: 6 weeks F: 24 weeks	Age: 20‐50 All had received medical therapy	26.5	Not available	Turkey	Outpatient
	C: sham acupuncture	50	46			27.0
Zhao 2015	I: early circumcision	384	358	D: 3 months F: 3 months	Age: mean 33 No specified previous treatment	21	2013‐2014	China	Outpatient
	C: delayed circumcision	390	355			21
Gallo 2014	I: lifestyle interventions	50	39	D: 3 months F: 3 months	Age: mean 33‐34 No specified previous treatment	22.1	2012‐2013	Italy	Outpatient
	C: no intervention	50	50			21.9
Kessler 2014	I: sono‐electromagnetic therapy	30	30	D: 12 weeks F: 16 weeks	Age: mean 44‐49 All had received medical therapy	25.1	2009‐2012	Switzerland	Outpatient
	C: placebo device	30	30			25.2
Kaikai 2014	I: ultrasound	35	35	D: 1 month F: 1 month	Age 18‐55 All had received medical therapy	25.9	2013‐2014	China	Outpatient
	C1: medical therapy	35	35			26.17
	C2: ultrasound + medical therapy	35	35			26.85
Vahdatpour 2013	I: extracorporeal shockwave	20	N/A	D: 4 weeks F: 12 weeks	Age: 35‐37 No specified previous treatment	26.5	2011‐2012	Iran	Outpatient
	C: sham procedure	20				27.1
Zeng 2012	I: extracorporeal shockwave therapy	40	38	D: 2 weeks F: 12 weeks	Age: mean 46‐49 No specified previous treatment	30.5	2009‐2011	China	Outpatient
	C: sham procedure	40	37			29.3
Gao 2012	I: medical therapy	30	30	D: 6 weeks F: 6 weeks	Age: mean 35‐36 No specified previous treatment	20.9/20.2	2008‐2009	China	Outpatient
	C1: transrectal hyperthermia	32	32			20/21.1
	C2: transrectal hyperthermia + medical therapy	43	43			22.4/21.7
Yang 2011	I1: biofeedback	20	20	D: 2 weeks F: 6 weeks	Age: mean 30 All had received medical therapy	26.92	2007	China	Outpatient
	I2: electrical stimulation	40	40			26.35
	I3: biofeedback + electrical stimulation	40	40			25.30
	C: usual care	40	40			25.82
Zhang 2011a	I: TaiJiQuan	50	N/A	D: 1 month F: 1 month	Age: 22‐50 No specified previous treatment	N/A	N/A	China	Outpatient
	C: no intervention	46
Samhan 2011	I: TENS	20	20	D: 4 weeks F: 4 weeks	Age: 30 to 55 No specified previous treatment	N/A	N/A	Egypt	Outpatient
	C: placebo TENS	20	20
Lee 2009	I1: electroacupuncture	12	11	D: 6 weeks F: 6 weeks	Age: 36‐40 No specified previous treatment	26.9	2007	Korea	Outpatient
	I2: sham procedure	12	10			25.5
	C: exercise and advise alone	12	12			28
Chen 2009	I1: acupuncture + moxibustion	42	42	D: 1 month F: 1 month	Age: 21‐52 No specified previous treatment	22.56	2004‐2007	China	Outpatient
	I2: acupuncture	41	41			21.97
	C: medical treatment	42	42			22.89
Zimmermann 2009	I: extracorporeal shockwave therapy	30	30	D: 4 weeks F: 12 weeks	Age: 22‐61 No specified previous treatment	25.07	N/A	Austria	Outpatient
	C: sham procedure	30	30			23.3
Fitzgerald 2013	I: myofascial trigger point therapy	10	9	D: 10 weeks F: 12 weeks	Age: mean 41‐45 All had received medical therapy	33.5	N/A	US	Outpatient
	C: Western massage	11	10			25.8
Marx 2009	I: osteopathic therapy	20	20	D: 8 weeks F: 14 weeks	Age: mean 46‐48 No specified previous treatment	22.85	2003‐2005	Germany	Outpatient
	C: exercise programme	15	13			22.95
Oh 2009	I: radiofrequency	N/A (abstract only)						South Korea	Outpatient
	C: "placebo therapy"
Kabay 2009	I: tibial nerve stimulation	45	45	D: 12 weeks F: 12 weeks	Age: mean 38‐39 No specified previous treatment	23.6	2006‐2008	Turkey	Outpatient
	C: sham procedure	44	44			22.8
Yoo 2009	I: medical therapy	44	37	D: 12 weeks F: 12 weeks	Age: mean 31‐38 No specified previous treatment	26.27	2005‐2010	South Korea	Outpatient
	C1: transrectal thermotherapy	44	41			24.59
	C2: transrectal thermotherapy + medical therapy	44	35			23.94
Lee 2008	I: acupuncture	45	44	D: 10 weeks F: 34 weeks	Age: 41‐43 No specified previous treatment	24.8	2004‐2005	Malaysia and US	Outpatient
	C: sham acupuncture	45	45			25.2
Sikiru 2008	I: TENS	8	8	D: 4 weeks F: 4 weeks	Age: 24‐60 No specified previous treatment	N/A	N/A	Nigeria	Outpatient
	C1: analgesic	8	8
	C2: control	8	8
Giubilei 2007	I: exercise programme	52	41	D: 18 weeks F: 18 weeks	Age: mean 36‐38 All had received medical therapy	23.46	2002‐2004	Italy	Outpatient
	C: flexibility programme (control intervention)	51	44			23.55
Paick 2006	I: extracorporeal magnetic innervation	21	21	D: 6 weeks F: 6 weeks	Age: mean 42‐49 No specified previous treatment	21	2003‐2004	South Korea	Outpatient
	C: medical therapy	19	19			17
Ateya 2006	I: medical therapy + prostatic massage	25	N/A	D: 4 weeks F: 4 weeks	Age: mean 35 No specified previous treatment	N/A	N/A	Egypt	Outpatient
	C: medical therapy	19
Shen 2006	I: medical therapy + prostatic massage	40	40	D: N/A F: after treatment	Age: 20‐46 No specified previous treatment	N/A	2002‐2005	China	Outpatient
	C: medical therapy	32	32
Rowe 2005	I: electromagnetic chair	11	11	D: 4 weeks F: 1 year	Age: 25‐67 All had received medical therapy	38.8/100	N/A	UK	Outpatient
	C: sham procedure	10	7			39.3/100
Fang 2005	I: He‐Ne laser	56	56	D: 5 weeks F: "after treatment"	Age: mean 33‐34 No specified previous treatment	N/A	2002‐2004	China	Outpatient
	C: routine care	56	56
Kastner 2004	I: transrectal thermotherapy 55 °C	42	21	D: once F: 12 months	Age: mean 58‐62 All had received medical therapy	11.5	N/A	Chile, Switzerland, UK	Outpatient
	C: transrectal thermotherapy 70 °C		18			10.9
Wang 2002	I: radiofrequency hyperthermia	76	76	D: 12 weeks F: 12 weeks	Age: mean 34.2 Not specified previous treatment	N/A	1998‐2001	China	Outpatient
	C: radiofrequency hyperthermia + terazosin	90	88
Leskinen 2002	I: transurethral needle ablation	25	25	D: once F: 12 months	Age: mean 43‐50 All had received medical therapy	37.3	1998‐2001	Finland	Outpatient
	C: sham procedure	8	8			33.6
Vassily 1999	I: transrectal thermotherapy	80	N/A	D: 2 weeks F: 6 months	N/A (abstract only)			Russia	Outpatient
	C: sham procedure	20
Nickel 1996	I: transurethral thermotherapy	10	10	D: 1 session F: 3 months	Age: 45‐46 All had received medical therapy	N/A	N/A	Canada	Outpatient
	C: sham procedure	10	10
Muraro 1995	I: medical therapy plus local hyperthermia	10	N/A	D: 15 days F: 4 weeks	Age: mean 42.5 Not specified previous treatment	N/A	N/A	Italy	Outpatient
	C: local hyperthermia alone	10
Montorsi 1993	Transrectal hyperthermia in different regimens	54	54	D: 3 to 6 weeks F: 26 months	Age: 21‐45 All had received medical therapy	N/A	1987‐1991	Italy	Outpatient
Shah 1993	I: radiofrequency	15	N/A	D: 2‐3 weeks F: 3 months	N/A (abstract only)			UK	Outpatient
	C: sham procedure	15

Acupuncture compared to sham procedure for chronic prostatitis/chronic pelvic pain syndrome
Patient or population: participants with chronic prostatitis/chronic pelvic pain syndrome Setting: outpatient, Korea, Malaysia, US and Turkey Intervention: acupuncture Comparison: sham procedure placing needles in different points from those used in acupuncture
Outcomes	№ of participants (studies)	Quality of the evidence (GRADE)	Relative effect (95% CI)	*Anticipated absolute effects^ (95% CI)**
				Risk with sham procedure	Risk difference with Acupuncture
Prostatitis Symptoms assessed with: NIH‐CPSI score Scale from: 0 to 43 follow up: 6‐8 weeks Benefit is indicated by lower scores	204 (3 RCTs)	⊕⊕⊕⊝ Moderate¹	‐	The mean prostatitis Symptoms ranged from 17.08 to 22	MD 5.79 lower (7.32 lower to 4.26 lower)
Prostatitis Symptoms assessed with: NIH‐CPSI score (response) follow up: 6 weeks	113 (2 RCTs)	⊕⊝⊝⊝ Very low^{1 2 3}	RR 2.49 (0.77 to 8.02)	Study population
				404 per 1.000	596 more per 1000 (93 fewer to 596 more)
Adverse events follow up: 6‐8 weeks	204 (3 RCTs)	⊕⊕⊝⊝ Low^{1 3}	RR 1.33 (0.51 to 3.46)	Study population
				58 per 1.000	19 more per 1000 (29 fewer to 143 more)
Sexual dysfunction assessed with: International Index of Erectile Function Scale from: 5 to 25 follow up: 6 weeks Benefit is indicated by higher scores	89 (1 RCT)	⊕⊕⊝⊝ Low^{1 4}	‐	The mean sexual dysfunction was 23	MD 0.5 lower (3.46 lower to 2.46 higher)
Quality of life ‐ not reported	‐	‐	‐	‐	‐
Depression and anxiety ‐ not reported	‐	‐	‐	‐	‐
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio; OR: Odds ratio;
GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect

Acupuncture compared to medical treatment for chronic prostatitis/chronic pelvic pain syndrome
Patient or population: treating chronic prostatitis/chronic pelvic pain syndrome Setting: outpatient, Korea, China and Turkey Intervention: acupuncture Comparison: medical treatment
Outcomes	№ of participants (studies)	Quality of the evidence (GRADE)	Relative effect (95% CI)	*Anticipated absolute effects (95% CI)**
				Risk with medical treatment	Risk difference with acupuncture
Prostatitis symptoms (NIH‐CPSI total) assessed with: NIH‐CPSI score Scale from: 0 to 43 follow‐up: 12 weeks Benefit is indicated by lower scores	78 (2 RCTs)	⊕⊕⊕⊝ Moderate^1,2	‐	The mean prostatitis symptoms (NIH‐CPSI total) ranged from 12 to 16	MD 6.05 lower (7.87 lower to 4.24 lower)
Prostatitis symptoms: response defined as a 6‐point decrease in NIH‐CPSI score follow‐up: 6 weeks³	24 (1 RCT)	⊕⊕⊝⊝ Low^1,3	RR 3.57 (1.45 to 8.80)	Study population
				250 per 1000	643 more per 1000 (112 more to 1950 more)
Adverse events follow‐up: 12 weeks	78 (2 RCTs)	⊕⊕⊝⊝ Low^1,3	‐	There were no adverse events in either group.
Sexual dysfunction ‐ not reported	‐	‐	‐	‐	‐
Quality of life ‐ not reported	‐	‐	‐	‐	‐
Depression and anxiety ‐ not reported	‐	‐	‐	‐	‐
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; MD: mean difference; NIH‐CPSI: National Institutes of Health ‐ Chronic Prostatitis Symptom Index; RCT: randomised controlled trial; RR: risk ratio.
GRADE Working Group grades of evidence High quality: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate quality: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low quality: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low quality: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.

Circumcision plus usual care compared to waiting list plus usual care for chronic prostatitis/chronic pelvic pain syndrome
Patient or population: participants with chronic prostatitis/chronic pelvic pain syndrome Setting: hospital (surgery), China Intervention: circumcision at 4 weeks (outcome was assessed after circumcision) Comparison: waiting list for circumcision at 3 months (outcome was assessed before circumcision)
Outcomes	№ of participants (studies)	Quality of the evidence (GRADE)	Relative effect (95% CI)	*Anticipated absolute effects (95% CI)**
				Risk with waiting list for circumcision	Risk difference with early circumcision
Prostatitis symptoms assessed with: NIH‐CPSI score Scale from: 0 to 43 follow‐up: 12 weeks Benefit is indicated by lower scores	713 (1 RCT)	⊕⊕⊕⊝ Moderate¹	‐	The mean prostatitis symptoms was 15	MD 3.00 lower (3.82 lower to 2.18 lower)²
Adverse events³ follow‐up: 12 weeks	713 (1 RCT)	⊕⊕⊝⊝ Low^1,4	RR 1.23 (0.86 to 1.76)	Study population
				130 per 1000	30 more per 1000 (18 fewer to 98 more)
Sexual dysfunction ‐ not reported	‐	‐	‐	‐	‐
Quality of life ‐ not reported	‐	‐	‐	‐	‐
Depression and anxiety ‐ not reported	‐	‐	‐	‐	‐
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; MD: mean difference; NIH‐CPSI: National Institutes of Health ‐ Chronic Prostatitis Symptom Index; RCT: randomised controlled trial; RR: risk ratio.
GRADE Working Group grades of evidence High quality: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate quality: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low quality: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low quality: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.

Electromagnetic chair compared to control intervention for chronic prostatitis/chronic pelvic pain syndrome
Patient or population: participants with chronic prostatitis/chronic pelvic pain syndrome Setting: outpatient, South Korea and England Intervention: electromagnetic chair Comparison: control intervention in which the electromagnetic chair was switched off
Outcomes	№ of participants (studies)	Quality of the evidence (GRADE)	Relative effect (95% CI)	*Anticipated absolute effects (95% CI)**
Outcomes	№ of participants (studies)	Quality of the evidence (GRADE)	Relative effect (95% CI)	Risk with control intervention	Risk difference with electromagnetic chair
Prostatitis symptoms assessed with: NIH‐CPSI score / Prostatitis Symptom Severity Score follow‐up: 6‐12 weeks Benefit is indicated by lower scores	57 (2 RCTs)	⊕⊝⊝⊝ Very low^1,2,3	‐	1 study found no differences in NIH‐CPSI score measurements at 6 weeks. The other study found a symptom score 16 points (0‐ to 90‐point scale) lower in the intervention group compared to the control group (P value not available) at 12 weeks.
Adverse events follow‐up: 6‐12 weeks	57 (2 RCTs)	⊕⊕⊝⊝ Low^1,4	‐	1 study reported a 0 incidence of adverse events and the other study reported 1 case of transient paraesthesia in the active treatment group.
Sexual dysfunction ‐ not reported	‐	‐	‐	‐	‐
Quality of life ‐ not reported	‐	‐	‐	‐	‐
Depression and anxiety ‐ not reported	‐	‐	‐	‐	‐
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; NIH‐CPSI: National Institutes of Health ‐ Chronic Prostatitis Symptom Index; RCT: randomised controlled trial.
GRADE Working Group grades of evidence High quality: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate quality: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low quality: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low quality: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.

Lifestyle modifications compared to control for chronic prostatitis/chronic pelvic pain syndrome
Patient or population: participants with chronic prostatitis/chronic pelvic pain syndrome Setting: outpatient, Italy Intervention: lifestyle modifications based on the assessment of risk factors for chronic prostatitis/chronic pelvic pain syndrome Comparison: control intervention in which participants were instructed to continue with the same lifestyle
Outcomes	№ of participants (studies) Follow‐up	Quality of the evidence (GRADE)	Relative effect (95% CI)	*Anticipated absolute effects (95% CI)**
				Risk with control	Risk difference with lifestyle modifications
Prostatitis symptoms: response defined as 6‐point decrease in NIH‐CPSI score follow‐up: 3 months Benefit is indicated by lower scores	100 (1 RCT)	⊕⊝⊝⊝ Very low^1,2	RR 3.90 (2.20 to 6.92)	Study population
				200 per 1000	580 more per 1000 (240 more to 1184 more)
Adverse events ‐ not reported	‐	‐	‐	‐	‐
Sexual dysfunction ‐ not reported	‐	‐	‐	‐	‐
Quality of life ‐ not reported	‐	‐	‐	‐	‐
Depression and anxiety ‐ not reported	‐	‐	‐	‐	‐
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; NIH‐CPSI: National Institutes of Health ‐ Chronic Prostatitis Symptom Index; RCT: randomised controlled trial; RR: risk ratio.
GRADE Working Group grades of evidence High quality: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate quality: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low quality: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low quality: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.

Physical activity compared to control intervention procedure for chronic prostatitis/chronic pelvic pain syndrome
Patient or population: participants with chronic prostatitis/chronic pelvic pain syndrome Setting: outpatient, Italy Intervention: physical activity programme Comparison: control intervention comprising a flexibility and motion low‐grade exercise programme
Outcomes	№ of participants (studies)	Quality of the evidence (GRADE)	Relative effect (95% CI)	*Anticipated absolute effects (95% CI)**
Outcomes	№ of participants (studies)	Quality of the evidence (GRADE)	Relative effect (95% CI)	Risk with sham procedure	Risk difference with physical activity
Prostatitis symptoms assessed with: NIH‐CPSI score Scale from: 0 to 43 follow‐up: 6 weeks Benefit is indicated by lower scores	85 (1 RCT)	⊕⊕⊝⊝ Low¹	‐	The mean prostatitis symptom score was 20	MD 2.50 lower (4.69 lower to 0.31 lower)
Adverse events ‐ not reported	‐	‐	‐	‐	‐
Sexual dysfunction ‐ not reported	‐	‐	‐	‐	‐
Quality of life ‐ not reported	‐	‐	‐	‐	‐
Anxiety assessed with: SAI‐Y score Scale from: 20 to 80 follow‐up: 6 weeks Benefit is indicated by lower scores	85 (1 RCT)	⊕⊝⊝⊝ Very low^1,2	‐	The mean anxiety score was 42.1	MD 2.8 lower (6.78 lower to 1.18 higher)
Depression assessed with: Beck Depression Inventory Scale from: 0 to 63 follow‐up: 6 weeks Benefit is indicated by lower scores	85 (1 RCT)	⊕⊝⊝⊝ Very low^1,2	‐	The mean depression score was 9.3	MD 0.5 higher (1.33 lower to 2.33 higher)
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; MD: mean difference; NIH‐CPSI: National Institutes of Health ‐ Chronic Prostatitis Symptom Index; RCT: randomised controlled trial; SAI‐Y: State Anxiety Inventory‐Y.
GRADE Working Group grades of evidence High quality: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate quality: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low quality: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low quality: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.

Prostatic massage compared to control for treating chronic prostatitis/chronic pelvic pain syndrome
Patient or population: participants with chronic prostatitis/chronic pelvic pain syndrome Setting: outpatient, Egypt Intervention: prostatic massage Comparison: no intervention
Outcomes	№ of participants (studies)	Quality of the evidence (GRADE)	Relative effect (95% CI)	*Anticipated absolute effects (95% CI)**
Outcomes	№ of participants (studies)	Quality of the evidence (GRADE)	Relative effect (95% CI)	Risk with control	Risk difference with prostatic massage
Prostatitis symptoms assessed with: NIH‐CPSI score Scale from: 0 to 43 follow‐up: 4 weeks Benefit is indicated by lower scores	44 (1 RCT)	⊕⊝⊝⊝ Very low^1,2	‐	The mean prostatitis symptom score was 12.4	MD 1.10 lower (5.63 lower to 3.43 higher)
Adverse events ‐ not reported	‐	‐	‐	‐	‐
Sexual dysfunction ‐ not reported	‐	‐	‐	‐	‐
Quality of life ‐ not reported	‐	‐	‐	‐	‐
Depression and anxiety ‐ not reported	‐	‐	‐	‐	‐
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; MD: mean difference; NIH‐CPSI: National Institutes of Health ‐ Chronic Prostatitis Symptom Index; RCT: randomised controlled trial.
GRADE Working Group grades of evidence High quality: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate quality: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low quality: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low quality: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.

Extracorporeal shockwave therapy compared to control procedure for chronic prostatitis/chronic pelvic pain syndrome
Patient or population: participants with chronic prostatitis/chronic pelvic pain syndrome Setting: outpatient, China, Austria, Iran Intervention: ESWT Comparison: 2 studies used a sham procedure (machine turned off) and 1 study compared to no ESWT
Outcomes	№ of participants (studies)	Quality of the evidence (GRADE)	Relative effect (95% CI)	*Anticipated absolute effects (95% CI)**
				Risk with control	Risk difference with ESWT
Prostatitis symptoms assessed with: NIH‐CPSI score Scale from: 0 to 43 follow‐up: 12 weeks Benefit is indicated by lower scores	157 (3 RCTs)	⊕⊕⊕⊕ High¹	‐	The mean prostatitis symptom score ranged from 16.8 to 26.81	MD 6.18 lower (7.46 lower to 4.89 lower)
Prostatitis symptoms: response defined as a 6‐point decrease in NIH‐CPSI score follow‐up: 12 weeks	135 (2 RCTs)	⊕⊝⊝⊝ Very low^2,3,4	RR 6.20 (0.48 to 79.79)	Study population
				149 per 1000	776 more per 1000 (78 fewer to 11,760 more)
Prostatitis symptoms assessed with: NIH‐CPSI score Scale from: 0 to 43 follow‐up: 24 weeks	97 (2 RCTs)	⊕⊕⊝⊝ Low^2,5	‐	The mean prostatitis symptom score ranged from 16.1 to 27	MD 2.23 lower (5.98 lower to 1.53 higher)
Adverse events follow‐up: 24 weeks	195 (3 RCTs)	⊕⊕⊝⊝ Low^2,4	RR 1.22 (0.59 to 2.51)	Study population
				93 per 1000	20 more per 1000 (38 fewer to 140 more)
Sexual dysfunction assessed with: International Index of Erectile Function Scale from: 5 to 25 follow‐up: 12 weeks Benefit is indicated by higher scores	60 (1 RCT)	⊕⊕⊕⊝ Moderate⁶	‐	The mean sexual dysfunction was 16.83	MD 3.34 higher (2.68 higher to 4 higher)
Quality of life ‐ not reported	‐	‐	‐	‐	‐
Depression and anxiety ‐ not reported	‐	‐	‐	‐	‐
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; ESWT: extracorporeal shockwave therapy; MD: mean difference; NIH‐CPSI: National Institutes of Health ‐ Chronic Prostatitis Symptom Index; RCT: randomised controlled trial; RR: risk ratio.
GRADE Working Group grades of evidence High quality: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate quality: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low quality: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low quality: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.

Transrectal thermotherapy compared to medical treatment for chronic prostatitis/chronic pelvic pain syndrome
Patient or population: participants with chronic prostatitis/chronic pelvic pain syndrome Setting: outpatient, China and Korea Intervention: transrectal thermotherapy Comparison: medical treatment
Outcomes	№ of participants (studies)	Quality of the evidence (GRADE)	Relative effect (95% CI)	*Anticipated absolute effects (95% CI)**
Outcomes	№ of participants (studies)	Quality of the evidence (GRADE)	Relative effect (95% CI)	Risk with medical treatment	Risk difference with transrectal thermotherapy
Prostatitis symptoms assessed with: NIH‐CPSI score Scale from: 0 to 43 follow‐up: 6 to 12 weeks Benefit is indicated by lower scores	140 (2 RCTs)	⊕⊕⊝⊝ Low¹	‐	The mean prostatitis symptom score ranged from 14.33 to 17.19	MD 2.50 lower (3.82 lower to 1.18 lower)
Adverse events ‐ not reported	‐	‐	‐	‐	‐
Sexual dysfunction ‐ not reported	‐	‐	‐	‐	‐
Quality of life ‐ not reported	‐	‐	‐	‐	‐
Depression and anxiety ‐ not reported	‐	‐	‐	‐	‐
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; MD: mean difference; NIH‐CPSI: National Institutes of Health ‐ Chronic Prostatitis Symptom Index; RCT: randomised controlled trial.
GRADE Working Group grades of evidence High quality: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate quality: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low quality: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low quality: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Prostatitis symptoms (NIH‐CPSI total)	3	204	Mean Difference (IV, Fixed, 95% CI)	‐5.79 [‐7.32, ‐4.26]
1.1 Acupuncture	2	180	Mean Difference (IV, Fixed, 95% CI)	‐5.71 [‐7.50, ‐3.91]
1.2 Electroacupuncture	1	24	Mean Difference (IV, Fixed, 95% CI)	‐6.0 [‐8.92, ‐3.08]
2 Prostatitis symptoms: pain subscore	3	204	Mean Difference (IV, Fixed, 95% CI)	‐2.43 [‐3.21, ‐1.66]
2.1 Acupuncture	2	180	Mean Difference (IV, Fixed, 95% CI)	‐2.00 [‐2.90, ‐1.10]
2.2 Electroacupuncture	1	24	Mean Difference (IV, Fixed, 95% CI)	‐3.6 [‐5.08, ‐2.12]
3 Prostatitis symptoms: micturition subscore	3	204	Mean Difference (IV, Fixed, 95% CI)	‐1.45 [‐1.83, ‐1.06]
3.1 Acupuncture	2	180	Mean Difference (IV, Fixed, 95% CI)	‐1.49 [‐1.89, ‐1.08]
3.2 Electroacupuncture	1	24	Mean Difference (IV, Fixed, 95% CI)	‐1.1 [‐2.26, 0.06]
4 Prostatitis symptoms: quality of life subscore	3	204	Mean Difference (IV, Fixed, 95% CI)	‐2.40 [‐3.09, ‐1.71]
4.1 Acupuncture	2	180	Mean Difference (IV, Fixed, 95% CI)	‐2.62 [‐3.37, ‐1.86]
4.2 Electroacupuncture	1	24	Mean Difference (IV, Fixed, 95% CI)	‐1.3 [‐1.00, 0.40]
5 Prostatitis symptoms	2	113	Risk Ratio (M‐H, Random, 95% CI)	2.49 [0.77, 8.02]
5.1 Acupuncture	1	89	Risk Ratio (M‐H, Random, 95% CI)	1.56 [1.09, 2.24]
5.2 Electroacupuncture	1	24	Risk Ratio (M‐H, Random, 95% CI)	5.00 [1.63, 15.31]
6 Prostatitis symptoms (NIH‐CPSI total) ‐ medium term	1	91	Mean Difference (IV, Fixed, 95% CI)	‐7.36 [‐9.93, ‐4.79]
7 Prostatitis symptoms: pain subscore ‐ medium term	1	91	Mean Difference (IV, Fixed, 95% CI)	‐3.25 [‐4.45, ‐2.05]
8 Prostatitis symptoms: micturition subscore ‐ medium term	1	91	Mean Difference (IV, Fixed, 95% CI)	‐1.02 [‐1.54, ‐0.50]
9 Prostatitis symptoms: quality of life subscore ‐ medium term	1	91	Mean Difference (IV, Fixed, 95% CI)	‐3.07 [‐4.14, ‐2.00]
10 Adverse events	3	204	Risk Ratio (M‐H, Fixed, 95% CI)	1.33 [0.51, 3.46]
10.1 Acupuncture	2	180	Risk Ratio (M‐H, Fixed, 95% CI)	1.64 [0.58, 4.62]
10.2 Electroacupuncture	1	24	Risk Ratio (M‐H, Fixed, 95% CI)	0.33 [0.01, 7.45]
11 Sexual dysfunction	1	89	Mean Difference (IV, Fixed, 95% CI)	‐0.5 [‐3.46, 2.46]
12 Urinary symptoms	2	113	Mean Difference (IV, Fixed, 95% CI)	‐2.79 [‐4.77, ‐0.82]
12.1 Acupuncture	1	89	Mean Difference (IV, Fixed, 95% CI)	‐2.5 [‐4.98, ‐0.02]
12.2 Electroacupuncture	1	24	Mean Difference (IV, Fixed, 95% CI)	‐3.30 [‐6.56, ‐0.04]

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Prostatitis symptoms (NIH‐CPSI total)	3	203	Mean Difference (IV, Random, 95% CI)	‐4.09 [‐6.87, ‐1.30]
1.1 Acupuncture	2	116	Mean Difference (IV, Random, 95% CI)	‐2.97 [‐9.36, 3.43]
1.2 Electroacupuncture	1	24	Mean Difference (IV, Random, 95% CI)	‐6.0 [‐8.50, ‐3.50]
1.3 Acupuncture (Moxibustion)	1	63	Mean Difference (IV, Random, 95% CI)	‐3.74 [‐7.41, ‐0.07]
2 Prostatitis symptoms: pain subscore	2	78	Mean Difference (IV, Fixed, 95% CI)	‐2.90 [‐4.05, ‐1.76]
2.1 Acupuncture	1	54	Mean Difference (IV, Fixed, 95% CI)	‐2.76 [‐4.57, ‐0.95]
2.2 Electroacupuncture	1	24	Mean Difference (IV, Fixed, 95% CI)	‐3.00 [‐4.48, ‐1.52]
3 Prostatitis symptoms: micturition subscore	2	78	Mean Difference (IV, Fixed, 95% CI)	‐1.15 [‐1.96, ‐0.35]
3.1 Acupuncture	1	54	Mean Difference (IV, Fixed, 95% CI)	‐0.95 [‐2.03, 0.13]
3.2 Electroacupuncture	1	24	Mean Difference (IV, Fixed, 95% CI)	‐1.4 [‐2.60, ‐0.20]
4 Prostatitis symptoms: quality of life subscore	2	78	Mean Difference (IV, Fixed, 95% CI)	‐1.41 [‐2.41, ‐0.41]
4.1 Acupuncture	1	54	Mean Difference (IV, Fixed, 95% CI)	‐1.18 [‐2.52, 0.16]
4.2 Electroacupuncture	1	24	Mean Difference (IV, Fixed, 95% CI)	‐1.70 [‐3.19, ‐0.21]
5 Prostatitis symptoms	1	24	Risk Ratio (M‐H, Fixed, 95% CI)	3.57 [1.45, 8.80]
5.1 Electroacupuncture	1	24	Risk Ratio (M‐H, Fixed, 95% CI)	3.57 [1.45, 8.80]
6 Adverse events	2		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected
6.1 Acupuncture	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
6.2 Electroacupuncture	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
7 Urinary symptoms	1	24	Mean Difference (IV, Fixed, 95% CI)	‐2.7 [‐4.00, 0.60]
7.1 Electroacupuncture	1	24	Mean Difference (IV, Fixed, 95% CI)	‐2.7 [‐4.00, 0.60]

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Prostatitis symptoms	1	713	Mean Difference (IV, Fixed, 95% CI)	‐3.0 [‐3.82, ‐2.18]
2 Prostatitis symptoms: pain subscore	1	713	Mean Difference (IV, Fixed, 95% CI)	‐1.0 [‐1.33, ‐0.67]
3 Prostatitis symptoms: micturition subscore	1	713	Mean Difference (IV, Fixed, 95% CI)	‐1.0 [‐1.22, ‐0.78]
4 Prostatitis symptoms: quality of life subscore	1	713	Mean Difference (IV, Fixed, 95% CI)	‐3.0 [‐3.38, ‐2.62]
5 Adverse events	1	713	Risk Ratio (M‐H, Fixed, 95% CI)	1.23 [0.86, 1.76]

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Prostatitis symptoms (NIH‐CPSI total)	2	57	Mean Difference (IV, Fixed, 95% CI)	‐3.0 [‐7.75, 1.75]
2 Prostatitis symptoms: pain subscore	2	57	Std. Mean Difference (IV, Fixed, 95% CI)	‐0.44 [‐1.07, 0.19]
3 Prostatitis symptoms: micturition subscore	2	57	Std. Mean Difference (IV, Fixed, 95% CI)	0.22 [‐0.40, 0.84]
4 Prostatitis symptoms: quality of life subscore	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
5 Adverse events	2	57	Risk Ratio (M‐H, Fixed, 95% CI)	2.18 [0.10, 46.92]
6 Urinary symptoms	1	40	Mean Difference (IV, Fixed, 95% CI)	0.0 [‐4.13, 4.13]
7 Prostatitis symptoms (NIH‐CPSI total) ‐ medium term	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
8 Prostatitis symptoms: pain subscore ‐ medium term	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

Transrectal thermotherapy (add‐on) compared to medical treatment alone for chronic prostatitis/chronic pelvic pain syndrome
Patient or population: participants with chronic prostatitis/chronic pelvic pain syndrome Setting: outpatient, China and Korea Intervention: transrectal thermotherapy in addition to medical therapy Comparison: medical treatment alone
Outcomes	№ of participants (studies) Follow‐up	Quality of the evidence (GRADE)	Relative effect (95% CI)	*Anticipated absolute effects (95% CI)**
Outcomes	№ of participants (studies) Follow‐up	Quality of the evidence (GRADE)	Relative effect (95% CI)	Risk with medical treatment alone	Risk difference with transrectal thermotherapy (add‐on)
Prostatitis symptoms assessed with: NIH‐CPSI score Scale from: 0 to 43 follow‐up: 6 to 12 weeks Benefit is indicated by lower scores	145 (2 RCTs)	⊕⊕⊝⊝ Low¹	‐	The mean prostatitis symptom score ranged from 14.33 to 17.19	MD 4.34 lower (5.65 lower to 3.04 lower)
Adverse events ‐ not reported	‐	‐	‐	‐	‐
Sexual dysfunction ‐ not reported	‐	‐	‐	‐	‐
Quality of life ‐ not reported	‐	‐	‐	‐	‐
Depression and anxiety ‐ not reported	‐	‐	‐	‐	‐
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; MD: mean difference; NIH‐CPSI: National Institutes of Health ‐ Chronic Prostatitis Symptom Index; RCT: randomised controlled trial.
GRADE Working Group grades of evidence High quality: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate quality: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low quality: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low quality: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.

Date	Event	Description
4 April 2018	New citation required but conclusions have not changed	This version has received feedback from the Central Editorial Unit regarding issues on GRADE judgements of Summary of Findings table 1, abstract and plain language structure and language. The authors have amended the review accordingly.
4 April 2018	Amended	This version has received feedback from the Central Editorial Unit regarding issues on GRADE judgements of Summary of Findings table 1, abstract and plain language structure and language. The authors have amended the review accordingly.

Conference	Website (last access October 2017)
American Urology Association May 2017	www.jurology.com/issue/S0022‐5347(17)X0003‐7
American Urology Association May 2016	www.jurology.com/issue/S0022‐5347(16)X0004‐3
American Urology Association May 2015	www.jurology.com/issue/S0022‐5347(14)X0014‐5
European Association of Urology 2017	eau17.uroweb.org/
European Association of Urology 2016	eaumunich2016.uroweb.org/resource‐centre/
European Association of Urology 2015	Not accessible
Society of Sexual Medicine of North America 2017 annual meeting	www.smsna.org/V1/
Society of Sexual Medicine of North America 2016 annual meeting
Society of Sexual Medicine of North America 2015 annual meeting

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Prostatitis symptoms	1	85	Mean Difference (IV, Fixed, 95% CI)	‐2.50 [‐4.69, ‐0.31]
2 Prostatitis symptoms: pain subscore	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
3 Prostatitis symptoms: micturition subscore	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
4 Prostatitis symptoms: quality of life subscore	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
5 Anxiety	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
6 Depression	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Prostatitis symptoms	1	44	Mean Difference (IV, Fixed, 95% CI)	‐1.10 [‐5.63, 3.43]
2 Prostatitis symptoms: pain subscore	2		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
3 Prostatitis symptoms: micturition subscore	2		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
4 Prostatitis symptoms: quality of life subscore	2		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Prostatitis symptoms (NIH‐CPSI total)	3	157	Mean Difference (IV, Random, 95% CI)	‐6.18 [‐7.46, ‐4.89]
1.1 Compared to sham procedure	2	97	Mean Difference (IV, Random, 95% CI)	‐6.14 [‐7.87, ‐4.41]
1.2 Compared to no intervention	1	60	Mean Difference (IV, Random, 95% CI)	‐6.64 [‐10.17, ‐3.11]
2 Prostatitis symptoms: pain subscore	2	97	Mean Difference (IV, Random, 95% CI)	‐4.64 [‐5.38, ‐3.89]
2.1 Compared to sham procedure	1	37	Mean Difference (IV, Random, 95% CI)	‐4.74 [‐5.54, ‐3.94]
2.2 Compared to no intervention	1	60	Mean Difference (IV, Random, 95% CI)	‐3.83 [‐6.03, ‐1.63]
3 Prostatitis symptoms: micturition subscore	2	97	Mean Difference (IV, Fixed, 95% CI)	‐0.53 [1.00, ‐0.07]
3.1 Compared to sham procedure	1	37	Mean Difference (IV, Fixed, 95% CI)	‐1.79 [‐2.59, ‐0.99]
3.2 Compared to no intervention	1	60	Mean Difference (IV, Fixed, 95% CI)	0.10 [‐0.47, 0.67]
4 Prostatitis symptoms: quality of life subscore	2	97	Mean Difference (IV, Random, 95% CI)	‐1.84 [‐2.41, ‐1.27]
4.1 Compared to sham procedure	1	37	Mean Difference (IV, Random, 95% CI)	‐1.73 [‐2.35, ‐1.11]
4.2 Compared to no intervention	1	60	Mean Difference (IV, Random, 95% CI)	‐2.46 [‐3.94, ‐0.98]
5 Prostatitis symptoms	2	135	Risk Ratio (M‐H, Random, 95% CI)	6.20 [0.48, 79.79]
6 Prostatitis symptoms (total score) ‐ long term	2	97	Mean Difference (IV, Random, 95% CI)	‐2.23 [‐5.98, 1.53]
6.1 Compared to sham procedure	1	37	Mean Difference (IV, Random, 95% CI)	‐0.59 [‐1.42, 0.24]
6.2 Compared to no intervention	1	60	Mean Difference (IV, Random, 95% CI)	‐4.47 [‐7.60, ‐1.34]
7 Prostatitis symptoms: pain subscore ‐ long term	2	97	Mean Difference (IV, Random, 95% CI)	‐2.08 [‐6.25, 2.09]
7.1 Compared to sham procedure	1	37	Mean Difference (IV, Random, 95% CI)	‐0.01 [‐1.26, 1.24]
7.2 Compared to no intervention	1	60	Mean Difference (IV, Random, 95% CI)	‐4.27 [‐6.15, ‐2.39]
8 Prostatitis symptoms: micturition subscore ‐ long term	2	97	Mean Difference (IV, Random, 95% CI)	‐0.64 [‐1.19, ‐0.10]
8.1 Compared to sham procedure	1	37	Mean Difference (IV, Random, 95% CI)	‐0.35 [‐1.50, 0.80]
8.2 Compared to no intervention	1	60	Mean Difference (IV, Random, 95% CI)	‐0.73 [‐1.35, ‐0.11]
9 Prostatitis symptoms: quality of life subscore ‐ long term	2	97	Mean Difference (IV, Random, 95% CI)	‐0.97 [‐2.78, 0.85]
9.1 Compared to sham procedure	1	37	Mean Difference (IV, Random, 95% CI)	‐0.16 [‐0.98, 0.66]
9.2 Compared to no intervention	1	60	Mean Difference (IV, Random, 95% CI)	‐2.03 [‐3.62, ‐0.44]
10 Adverse events	3	195	Risk Ratio (M‐H, Fixed, 95% CI)	1.22 [0.59, 2.51]
11 Sexual dysfunction	1	60	Mean Difference (IV, Fixed, 95% CI)	3.34 [2.68, 4.00]
12 Urinary symptoms	1	60	Mean Difference (IV, Fixed, 95% CI)	‐4.50 [‐5.14, ‐3.86]

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Prostatitis symptoms (NIH‐CPSI total)	2		Mean Difference (IV, Fixed, 95% CI)	Subtotals only
1.1 Compared to medical therapy	2	140	Mean Difference (IV, Fixed, 95% CI)	‐2.50 [‐3.82, ‐1.18]
1.2 Add‐on to medical therapy vs medical therapy alone	2	145	Mean Difference (IV, Fixed, 95% CI)	‐4.34 [‐5.65, ‐3.04]
2 Prostatitis symptoms: pain subscore	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
2.1 Compared to medical therapy	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
2.2 Add‐on to medical therapy vs medical therapy alone	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
3 Prostatitis symptoms: micturition subscore	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
3.1 Compared to medical therapy	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
3.2 Add‐on to medical therapy vs medical therapy alone	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
4 Prostatitis symptoms: quality of life subscore	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
4.1 Compared to medical therapy	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
4.2 Add‐on to medical therapy vs medical therapy alone	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Prostatitis symptoms (NIH‐CPSI total)	1	89	Mean Difference (IV, Fixed, 95% CI)	‐11.2 [‐12.92, ‐9.48]
2 Prostatitis symptoms: pain subscore	1	89	Mean Difference (IV, Fixed, 95% CI)	‐5.70 [‐6.90, ‐4.50]
3 Prostatitis symptoms: micturition subscore	1	89	Mean Difference (IV, Fixed, 95% CI)	‐3.20 [‐3.77, ‐2.63]
4 Prostatitis symptoms: quality of life subscore	1	89	Mean Difference (IV, Fixed, 95% CI)	‐4.6 [‐5.27, ‐3.93]

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Prostatitis symptoms (NIH‐CPSI total)	1	21	Mean Difference (IV, Fixed, 95% CI)	1.0 [‐6.45, 8.45]
2 Prostatitis symptoms: pain subscore	1	21	Mean Difference (IV, Fixed, 95% CI)	‐0.20 [‐5.04, 4.64]
3 Prostatitis symptoms: micturition subscore	1	21	Mean Difference (IV, Fixed, 95% CI)	1.1 [‐1.12, 3.32]
4 Prostatitis symptoms: quality of life subscore	1	21	Mean Difference (IV, Fixed, 95% CI)	0.10 [‐2.90, 3.10]
5 Sexual dysfunction	1	21	Mean Difference (IV, Fixed, 95% CI)	‐2.20 [‐9.24, 4.84]
6 Quality of life ‐ physical	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
7 Quality of life ‐ mental	1	19	Mean Difference (IV, Fixed, 95% CI)	0.80 [‐9.25, 10.85]

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Prostatitis symptoms (NIH‐CPSI total)	1	60	Mean Difference (IV, Fixed, 95% CI)	‐2.80 [‐6.75, 1.15]
2 Prostatitis symptoms	1	60	Risk Ratio (M‐H, Fixed, 95% CI)	1.4 [0.91, 2.15]
3 Prostatitis symptoms: pain subscore	1	60	Mean Difference (IV, Fixed, 95% CI)	‐1.30 [‐3.44, 0.84]
4 Prostatitis symptoms: micturition subscore	1	60	Mean Difference (IV, Fixed, 95% CI)	0.0 [‐1.26, 1.26]
5 Prostatitis symptoms: quality of life subscore	1	60	Mean Difference (IV, Fixed, 95% CI)	‐1.40 [‐2.76, ‐0.04]

Non‐pharmacological interventions for treating chronic prostatitis/chronic pelvic pain syndrome

Abstract

Background

Objectives

Search methods

Selection criteria

Data collection and analysis

Main results

Authors' conclusions

Plain language summary

Summary of findings

Background

Description of the condition

Description of the intervention

Pharmacological interventions

Non‐pharmacological interventions

Multimodal approaches

Adverse events

Clinical phenotyping

How the intervention might work

Pharmacological interventions

Non‐pharmacological interventions

Why it is important to do this review

Objectives

Methods

Criteria for considering studies for this review

Types of studies

Types of participants

Types of interventions

Non‐pharmacological interventions

Multimodal approaches

Comparator interventions

Comparisons

Types of outcome measures

Primary outcomes

Secondary outcomes

Method and timing of outcome measurement

Prostatitis symptoms

Adverse events

Sexual dysfunction

Urinary symptoms

Quality of life

Depression and anxiety

Main outcomes for 'Summary of findings' tables

Search methods for identification of studies

Electronic searches

Searching other resources

Data collection and analysis

Selection of studies

Data extraction and management

1

2

Dealing with duplicate and companion publications

Assessment of risk of bias in included studies

Measures of treatment effect

Unit of analysis issues

Dealing with missing data

Assessment of heterogeneity

Assessment of reporting biases

Data synthesis

Subgroup analysis and investigation of heterogeneity

Sensitivity analysis

'Summary of findings' tables

Results

Description of studies

Results of the search

Included studies

Design

Sample sizes

Setting

Participants

Interventions

Outcomes

Funding sources

Excluded studies

Risk of bias in included studies

Allocation

Random sequence generation

Allocation concealment

Blinding

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Prostatitis symptoms: pain subscore	2		Mean Difference (IV, Fixed, 95% CI)	Subtotals only
1.1 Compared to sham procedure	1	40	Mean Difference (IV, Fixed, 95% CI)	‐15.25 [‐17.71, ‐12.79]
1.2 Compared to no intervention	1	16	Mean Difference (IV, Fixed, 95% CI)	‐6.88 [‐8.13, ‐5.63]

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Prostatitis symptoms (NIH‐CPSI total)	1	33	Mean Difference (IV, Fixed, 95% CI)	2.30 [‐8.02, 12.62]
2 Urinary symptoms	1	33	Mean Difference (IV, Fixed, 95% CI)	0.40 [‐5.09, 5.89]

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Prostatitis symptoms (NIH‐CPSI total)	2	78	Mean Difference (IV, Random, 95% CI)	‐6.05 [‐7.87, ‐4.24]
1.1 Acupuncture	1	54	Mean Difference (IV, Random, 95% CI)	‐6.11 [‐8.75, ‐3.47]
1.2 Electroacupuncture	1	24	Mean Difference (IV, Random, 95% CI)	‐6.0 [‐8.50, ‐3.50]

Methods	Study design: parallel group randomised trial. Study dates: not available. Setting: academic hospital, outpatient, national. Country: Egypt.
Participants	Inclusion criteria: consecutive participants who attended outpatient clinic with history or symptoms suggestive of CP (NIH category II and IIIa). Exclusion criteria: presence of cancer of genitourinary tract; active urinary stone disease or herpes of the genitourinary system; perirectal inflammatory disorders; inflammatory bowel disease; history of pelvic radiation or systemic chemotherapy; history of intravesical chemotherapy; urethral stricture ≤ 12 F; neurological disease or disorder affecting bladder; and prostate surgery (not including cystoscopy) within the past 3 months. Sample size: 81. Age (years): overall 35.3 (SD 9.0). Baseline NIH‐CPSI score: not available. Sex: men.
Interventions	Group 1 (n = 17): participants with chronic bacterial prostatitis who received antibiotics (targeted to culture) and prostatic massage (performed 3 times weekly for 4 weeks). Prostate was massaged from above and lateral to gland, 6 times on each side, by gentle and firm pressure of finger directed downwards and inwards, followed by a few strokes in the middle from above downwards. Group 2 (n = 20): participants with chronic bacterial prostatitis who received only antibiotics. Group 3 (n = 25): participants with CP/CPPS who received antibiotics empirically and prostatic massage. Group 4 (n = 19): participants with CP/CPPS who received antibiotics empirically alone. Cointerventions: none described.
Outcomes	Prostatitis symptoms How measured: NIH‐CPSI. Time points measured: before treatment and end of study. Time points reported: before and after treatment.
Funding sources	Not available.
Declarations of interest	Not available.
Notes	Only group 3 and 4 analysed.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No information available. Study authors did not answer.
Allocation concealment (selection bias)	Unclear risk	No information available. Study authors did not answer.
Blinding of participants and personnel (performance bias) Subjective outcomes	High risk	Open label study.
Blinding of outcome assessment (detection bias) All outcomes	High risk	Open label study.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	No information regarding follow‐up for all outcomes. Study authors did not answer.
Selective reporting (reporting bias)	Unclear risk	Protocol not available. Wrote to authors to clarify time point of NIH‐CPSI score measurement, but they did not answer.
Other bias	Unclear risk	Basal characteristics for each group not presented for variables of interest. We wrote to authors, but they did not answer.

Methods	Study design: randomised, double‐blind, sham controlled trial. Study dates: 'study dates not available.' Setting: outpatient academic hospital. Country: Canada.
Participants	Inclusion criteria: clinical diagnosis of non‐bacterial prostatitis and with symptoms over 12 months; 10 WBC their prostate massage or post‐prostatic massage urine. Participants had a symptom severity of ≥ 5 (0‐10 scale for each domain) in 3 domains of the symptom severity index and ≥ 3 (0‐5 for each domain) in 3 domains of the symptom frequency questionnaire (total score ≥ 20). Exclusion criteria: positive cultures of expressed prostatic fluid or postprostatic massage urine, history of urinary tract infections, response to antibiotics. Sample size: total 20. Age (years): Group 1: mean 45.8; Group 2: mean 44.8. Baseline NIH‐CPSI score (PSSI): not available. Sex: men.
Interventions	Group 1: transurethral microwave thermotherapy: single 1‐hour treatment with a computer‐driven device that elevated prostate interstitial temperatures to 45‐60 °C, a range that does not cause significant necrosis of normal prostatic tissue. Group 2: sham therapy: single 1‐hour session with the same device using sham software. Cointerventions: in phase 2, all participants in both groups who did not show significant improvement after initial therapy were offered a 2nd treatment; this phase was open labelled.
Outcomes	Prostatitis symptoms How measured: symptom severity index and symptom frequency questionnaire. Time points measured: 3 months (phase 1) and 21 months (phase 2). Time points reported: 3 months and 21 months (in a subgroup). Urinary symptoms How measured: American Urology Association symptom score. Time points measured: 3 months (phase 1) and 21 months (phase 2). Time points reported: 3 and 21 months (in a subgroup). Adverse events How measured: narratively.
Funding sources	Not available.
Declarations of interest	Not available.
Notes	None.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No information available.
Allocation concealment (selection bias)	Unclear risk	No information available.
Blinding of participants and personnel (performance bias) Subjective outcomes	Unclear risk	Quote: 'The patient and evaluating urologist (J. C. N.) were blinded as to the actual therapy performed. Phase 1 of the trial consisted of the randomized double blind.' Unclear if all personnel were blinded.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: 'The patient and evaluating urologist (J. C. N.) were blinded as to the actual therapy performed. Phase 1 of the trial consisted of the randomized double blind.'
Incomplete outcome data (attrition bias) All outcomes	Low risk	All outcomes: outcome data available for all randomised participants.
Selective reporting (reporting bias)	Unclear risk	No protocol available.
Other bias	Unclear risk	Baseline characteristics not available.

Study	Reason for exclusion
Aboumarzouk 2012	Cochrane systematic review.
Aliaev 2006	Non‐randomised comparative study for Sabal serrulata plant extract (study in Russian).
Allen 2017	Non‐randomised controlled trial of thermobalancing therapy for CP/CPPS.
Anothaisintawee 2011	Systematic review.
Barbalias 1998	Included participants with bacterial prostatitis. CP/CPPS definition did not include pain.
Bschleipfer 2007	"Intraprostatic botulinum toxin A injection" trial. Personal contact with author confirmed that trial was stopped due to problems in recruiting (prospective participants with high levels of liver enzymes).
Capodice 2005	Systematic review. Complementary medicine.
Chambo 2009	Cochrane systematic review (Cochrane Review Group confirmed that this is a withdrawn protocol).
Chang 2016	Systematic review. Acupuncture.
Chen 2006	Systematic review. TCM.
Chuang 2006	Systematic review. Acupuncture.
Cohen 2012	Systematic review.
Colleen 1975	Non‐randomised cross‐over comparative study for minocycline.
DRKS00009352	Non‐randomised controlled trial for physiotherapeutic device and thermobalancing therapy.
Erickson 2008	Systematic review.
Evliyaoglu 2002	Quasi‐randomised study of doxazosin vs placebo.
Feng 2011	Trial of nursing interventions included participants with bacterial prostatitis.
Galeone 2012	Prolexan trial. 60% had bacterial prostatitis, no disaggregated results available.
Glybochko 2014	Electrode plasmapheresis for chronic bacterial prostatitis.
Golubchikov 2005	Non‐randomised controlled trial for a "combined treatment including complex physical factors."
Hong 2008	Abdominal cluster needle, quasi‐randomised trial (randomisation based on date of admission).
Ikeuchi 1990	Study was assessed by Cochrane Japan collaborators. Non‐randomised study for kampo medicine.
ISRCTN43221600	Non‐randomised study for a "combined psycho‐ and physiotherapeutic treatment program for patients with chronic pelvic pain syndrome (CPPS)."
Jimenez‐Pacheco 2014	Abstract of a systematic review on "therapeutic alternatives."
Kalinina 2015	Non‐randomised trial for a dietary supplement Prostatinol.
Kamalov 2006	Non‐randomised trial for rectal suppositoria Vitaprost.
Kogan 2010	Non‐randomised controlled trial for "magnetolaser therapy."
Kotarinos 2009	Observational study secondary to a myofascial trigger point release RCT (included in twin review "Non‐pharmacological interventions for treating chronic prostatitis/chronic pelvic pain syndrome").
Le 2011	Systematic review.
Lee 2006	Non‐randomised study for "Uro‐Vaxom."
Lee 2007	Systematic review. Alpha‐blockers.
Leng 2007	Non‐randomised study for a combination of TCM and Western medicine.
Liu 2016	Systematic review. Acupuncture for CP/CPPS.
Lokshin 2010	Trial for "combination (ciprofloxacin+doxazosin) vs. monotherapy (ciprofloxacin)." Trial included participants with bacterial prostatitis.
Lopatkin 2009	Non‐randomised controlled study for vitaprost (translated from Russian).
Loran 2003	Non‐randomised controlled study for Gentos.
Ma 2015	Quasi‐randomised study for "catgut embedding therapy."
Magistro 2016	Systematic review.
Marx 2013	Report of a single arm of the osteopathy trial after 5 years (included in the twin review "Non‐pharmacological interventions for treating chronic prostatitis/chronic pelvic pain syndrome").
McNaughton 2000	Systematic review.
McNaughton 2001	Cochrane systematic review.
McNaughton 2002	Cochrane systematic review. Allopurinol.
Mishra 2008	Systematic review.
NCT00194597	Trial for Viagra (sildenafil). Study terminated due to illness of principal investigator.
NCT00194623	Study on Botox terminated since reorganisation of personnel forced termination.
NCT00194636	Study on "Sympathetic Plexus Block" suspended participant recruitment (principal investigator health issues).
NCT00301405	Study on "Thalidomide" terminated. (Study closed. Difficult enrolment of men with prostatitis.)
NCT00464373	Trial of botulinum toxin type A as single intrasphincteric injection. Study terminated due to slow accrual.
NCT00529386	Personal contact with author (Dr Nickel): trial stopped for futility before endpoint, it was never published, "8 patients received botox as per protocol 1 patient had mild improvement." Based on slow enrolment and poor results, trial was discontinued. No follow‐up or report other than to the Institutional Review Board.
NCT01678911	Study on Gralise terminated due to difficulties in recruitment and low enrolment.
NCT01830829	Study terminated due to difficulty in enrolling participants. Study for JALYN (dutasteride‐tamsulosin combination).
NCT02042651	Study withdrawn prior to enrolment.
Nickel 2011	Analysis of effects of dutasteride in men with CP/CPPS symptoms. Included participants not evaluated to reach a diagnosis of CP/CPPS. RCT objective was prevention of prostate cancer.
Osborn 1981	Non‐randomised study cross‐over trial of muscle relaxants.
Pavone 2010	Non‐randomised study of Serenoa repens for people with LUTS.
Posadzki 2012	Systematic review. Acupuncture.
Pushkar' 2006	Active treatment and comparison group comprised of 27% (6/22) of people with bacterial prostatitis. No disaggregated data for people with CP/CPPS.
Qin 2016a	Systematic review. Acupuncture.
Qin 2016b	Systematic review. Medical therapy (network meta‐analysis).
Razumov 2005	Non‐randomised study of "combined physiotherapy."
Simmons 1985	Definition of CP/CPPS did not match current definition. In fact, some participants had "non‐specific urethritis" and 6 participants were asymptomatic at beginning of study.
Stamatiou 2014	Quasi‐randomised study of antibiotic vs phytotherapeutic therapy.
Takahashi 2005	Study assessed by Cochrane Japan collaborators. Non‐randomised study for levofloxacin and cernitin pollen extract.
Thakkinstian 2012	Systematic review of "alpha‐blockers, antibiotics and anti‐inflammatories."
Thin 1983	Non‐randomised study for the comparison of "minocycline, trimethoprim, co‐trimoxazole or diazepam."
Tkachuk 2006	Non‐randomised study for "Vitaprost."
Tkachuk 2011	Non‐randomised study for "Vitaprost" as add‐on therapy to physiotherapy.
Wagenlehner 2017	Phase II, dose‐finding study with adaptive randomisation design.
Xu 2004	Non‐randomised study of combination therapy (antibiotics, alpha‐blockers, TCM, etc.).
Yang 2006	Systematic review. Alpha‐blockers.
Yang 2008	Systematic review.
Zhang 2011b	Diagnosis of CP/CPPS was not according to the review definition. Authors referred to the presence of both "Chinese medicine (CM) Gan (肝)‐qi stagnancy syndrome type" and benign prostatic hyperplasia.
Zhou 2017	Definition of study population was not according to NIH criteria.

Methods	'Self Management Activation Randomised Trial for Prostatitis (SMART‐P).' Randomised controlled trial.
Participants	Inclusion criteria: men with CP/CPPS refractory to simple pharmacological manipulation from general urology clinics at Norfolk and Norwich University hospitals. Aged > 18 years with CP/CPPS made by a urologist referred for 1st time by their general practitioner. Participants must be refractory to antibiotic treatment. Exclusion criteria: abnormal serum prostate specific antigen level; suspected prostate cancer on digital rectal examination; active urinary tract infection; alternative cause for pain found by urologist (e.g. ureteric calculus). Age: adult. Sex: men. Target number of participants: 120. Recruitment start date: 25 March 2011. Recruitment end date: 24 March 2012.
Interventions	Men will be randomised to attend either self‐management health and care education programme or pain clinic referral alone. Standard care: after exclusion of a treatable bacterial cause for CP/CPPS, referral to pain clinic will be through agreement between clinician and participant. Pharmacological agents such as gabapentin, pregabalin and antidepressants are the mainstay of standard care at present. Intervention: this group will take part in a course of 6 weekly small group sessions (5‐8 men) developed in conjunction with experts in psychology, pain management and urology, each lasting 1 hour with a focus on: understanding physiology of pain; psychological contributors; pain‐coping mechanisms; behavioural responses; prevention, rehabilitation and re‐enablement; relationships between symptom distress, emotion and pain. Sessions will enable participants to learn techniques of problem solving and goal setting. Supported self‐care and 'co‐production' will be the underlying principles of this programme. The initial session is an introduction to the programme requirements, the rationale and the value of the approach. In early sessions, participants are instructed in the use of the Reaction Record for self‐identifying and modifying catastrophic cognition and in understanding how such thinking is associated with greater negative affect, how there is little supportive evidence for such thinking, and how it can lead to poor choices in behavioural coping. During following sessions, participants identify and modify deficits in social support by practicing self‐assertion communication exercises with their instructor and then later with significant others in their lives while using the Reaction Record to examine how to better negotiate distressing episodes. Further sessions use the Reaction Record tool to identify and modify illness‐focused behavioural coping strategies and also to help re‐engage the participant in physical and social activities that they may have abandoned. In the final session, participants are provided with a detailed review of their acquired behavioural modifications. Following this discussion, participants are instructed on continued problem‐solving skills and future self‐management challenges are discussed.
Outcomes	Primary outcomes: changes in the NIH‐CPPS, a validated scoring system for assessing the severity of the condition, which will be measured before and after the intervention. Secondary outcomes: assess functional status (Hospital Anxiety and Depression and 36‐item Short Form score); changes in requirements for pain‐relief medication will also be used as a measure of effectiveness; participants degree of self‐management/activation will be assessed by the Patient Activation Measure questionnaire; outcomes will be measured before and after the intervention.
Notes	Wrote to: kathryn.andrews@nnuh.nhs.uk (email returned). Wrote to: mark.rochester@nnuh.nhs.uk (no response).

Trial name or title	A Randomised Controlled Trial of Psychological Intervention Therapy in Patients with Category III Chronic Prostatitis/Chronic Pelvic Pain Syndrome.
Methods	Randomised parallel controlled trial.
Participants	Inclusion criteria: frequent urination, dribbling urine sense and perineum, testicles, lumbosacral pain, discomfort and other symptoms (history > 3 months); prostate massage fluid abnormalities; prostate massage fluid bacterial culture negative; no antibiotics and alpha‐blocker previous treatment history. Exclusion criteria: urinary tract infections, benign prostatic hyperplasia and other pelvic organs diseases.
Interventions	Intervention: psychological intervention therapy. Control: routine treatment.
Outcomes	Primary outcome: NIH‐CPSI score. Secondary outcome: IIEF score, SAS score, SDS score.
Starting date	September 2016.
Contact information	Wang Jianxin: wangzijx2009@aliyun.com.
Notes	'IPD will be public accessible via ResMan after 2019‐03‐01.'

Trial name or title	Shocking Therapy for Chronic Pelvic Pain Syndrome (CPPS).
Methods	Randomised controlled trial, cross‐over assignment. Double blind (participants and care provider).
Participants	Inclusion criteria: exhibit symptoms of pain typical for prostatitis/CPPS; have had symptoms for ≥ 3 months; have no evidence of infection in urine or expressed prostatic secretions (seminal plasma may be substituted if expressed prostatic secretions not available); have failed ≥ 1 therapy for CPPS. Exclusion criteria: suspected or confirmed to have prostate cancer; have a coagulation disorders; use anticoagulants; have thrombosis; have used cortisone therapy up to 6 weeks before 1st treatment; are actively trying to conceive.
Interventions	Intervention: shockwave therapy, 4 sessions at 3000 pulses using Storz Duolith SD1 device. Control: placebo procedure for 4 sessions. Groups will cross‐over after the 4 sessions.
Outcomes	Primary outcome: Changes in pain at 32 weeks. Changes in pain is measured by a visual analogue scale from question 4 from the NIH‐CPSI.
Starting date	February 2013.
Contact information	Keith Jarvi, MD (Mount Sinai Hospital, Canada). No other contact information is provided in clinical trial registry.
Notes	Estimated completion date: December 2017.

Trial name or title	Efficacy of Acupuncture for Chronic Prostatitis/Chronic Pelvic Pain Syndromes.
Methods	Randomised controlled trial, parallel group assignment. Double blind (participants and outcome assessors).
Participants	Age 18‐50 years. Inclusion criteria: history of pain perceived in region of prostate and absence of other lower urinary tract pathology for ≥ 3 out of the past 6 months. In addition, associated lower urinary tract symptoms, sexual function and psychological factors should be addressed; age 18‐50 years; NIH‐CPSI total score ≥ 15 (scale 0‐43, and 0 means no symptom). Exclusion criteria: other urological disease (e.g. acute prostatitis, bacterial prostatitis, benign prostatic hyperplasia, prostate cancer, urinary tuberculosis, urinary tract infection); serious or acute diseases with heart, liver, kidney and blood system; participants who had received acupuncture or medication (including alpha‐blockers or pain killers) treatment in the week prior to the baseline assessment; participants without telephone number who cannot be connected during the follow‐up.
Interventions	'Experimental: Acupuncture Zhongliao (BL 33), Shenshu (BL 23), Huiyang (BL 35), and Sanyinjiao (SP 6) acupuncture points (Table 1). After patients are in prone position with relax, the investigators will use 75% alcohol pads to sterile the skin around the acupuncture points, and then insert steel needles (Huatuo, Suzhou, China 0.3mm40mm/0.3mm75mm) into the acupuncture points. For bilateral Zhongliao (BL 33), the needle will be inserted into about 50‐60mm with 45 degree, for Huiyang (BL 35), the needle will be inserted into 50‐60mm. for Shenshu (BL 23) and Sanyinjiao (SP 6), the needles will be inserted vertically to a depth of 25‐30 mm. The treatment sessions are 24 after baseline, 3 times a week, and the each time the patients will accept a 30 minutes treatment.' 'Placebo Comparator: placebo needle The participants in placebo needle group will receive placebo needle at the same acupuncture points to treatment group.'
Outcomes	Primary outcome: NIH‐CPSI total score and change from baseline (baseline, and weeks 1 and 8). Secondary outcomes: NIH‐CPSI subscales score: baseline, and week 4, 8, 20 and 32; NIH‐CPSI total score in follow‐up: baseline, and weeks 4, 8, 20 and 32; IPSS total score and change from baseline: baseline, and weeks 4, 8, 20 and 32. Other outcomes (not relevant to this review): global response assessment improvement; degree of satisfaction.
Starting date	November 2015.
Contact information	Zhishun Liu: liuzhishun@aliyun.com.
Notes	Estimated study end: May 2017.