| Methods | Study design: parallel group randomised trial. Study dates: not mentioned. Setting: Department of Urology, Elisabethinen Hospital. Country: Linz, Austria. | |
| Participants | Inclusion criteria: participants with type IIIb prostatitis (CPPS) of at least 3 months' duration and no evidence of bacteria in urinary and seminal culture tests. Exclusion criteria: participants with other prostate pathologies, such as prostate cancer. Sample size: 60. Age (years): Treatment group: 42 (range: 22‐52). Placebo group: 43 (range: 34‐61). Baseline NIH‐CPSI score: Group 1: 25.07 (SE 0.48); Group 2: 23.3 (SE 0.66). Sex: not applicable. | |
| Interventions | Group 1 (n = 30): 1 perineally applied ESWT treatment weekly (3000 pulses each; maximum total energy flow density: 0.25 mJ/mm2; frequency: 3 Hz) for 4 weeks. Position of shockwave transducer changed after every 500 pulses to scan virtually the entire prostatic and pelvic floor region. Device used for the study was standard electromagnetic shockwave unit with a focused shockwave source (Duolith SD1, Storz Medical, Tägerwilen, Switzerland). Focus zone penetration depth was 35‐65 mm. Group 2 (n = 30): placebo performed with same therapy head, which was also fitted with a placebo stand‐off. This stand‐off contained shock wave‐absorbing material, a layer of air and air‐filled microspheres. Cointerventions: none. | |
| Outcomes | Prostatitis symptoms How measured: NIH‐CPSI score and subscores. Time points measured: 1, 4 and 12 weeks following 1st session. Time points reported: 1, 4 and 12 weeks following 1st session. Subgroups: none. Urinary symptoms How measured: IPSS score. Time points measured: 1, 4 and 12 weeks following 1st session. Time points reported: 1, 4 and 12 weeks following 1st session. Subgroups: none. Sexual dysfunction How measured: International Index of Erectile Function. Time points measured: 1, 4 and 12 weeks following 1st session. Time points reported: 1, 4 and 12 weeks following 1st session. Subgroups: none. Adverse events How measured: narratively. | |
| Funding sources | None. | |
| Declarations of interest | None known. | |
| Notes | None. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | They reported that their sample was randomly recruited. However, did not explain their method of randomisation. |
| Allocation concealment (selection bias) | Unclear risk | No information on selection bias. |
| Blinding of participants and personnel (performance bias) Subjective outcomes | Low risk | Blinding included the specification that neither participant nor investigator/follow‐up observer was aware of placebo or verum assignment. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Blinding included the specification that neither participant nor investigator/follow‐up observer was aware of placebo or verum assignment. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | All outcomes: outcome data available for all participants. |
| Selective reporting (reporting bias) | Low risk | No suspicion of selective reporting. Reference of study protocol within study report. |
| Other bias | Low risk | No other sources of bias identified. |
CFU: colony‐forming unit; CP: chronic prostatitis; CPPS: chronic pelvic pain syndrome; EMG: electromyography; EPS: expressed prostate secretions; ESWT: extracorporeal shockwave therapy; IPSS: International Prostate Symptom Score; HPF: high power field; IQR: interquartile range; min: minute; n: number of participants; NIH: National Institutes of Health; NIH‐CPSI: National Institutes of Health ‐ Chronic Prostatitis Symptom Index; NSAID: non‐steroidal anti‐inflammatory drug; PSSI: Prostatitis Symptom Severity Index; PTNS: posterior tibial nerve stimulation; SD: standard deviation; SE: standard error; TENS: transcutaneous electrical nerve stimulation; TRFH: transrectal radiofrequency hyperthermia; TUNA: transurethral needle ablation; WBC: white blood cell.