Methods | Study design: parallel group randomised trial. Study dates: November 1987 to July 1991. Setting: presumably national, outpatient. Country: presumably Italy. | |
Participants | Inclusion criteria: participants with chronic abacterial prostatitis or prostatodynia. Mean duration of subjective symptoms, as assessed by a modified Boyarsky scale, 2.3 years (range 8 months ‐ 4 years). Of the participants with these diagnoses, only those who had experienced reoccurrence of the subjective symptoms after antibiotic therapy were eligible to enter study. Exclusion criteria: type of pathology not explicitly stated. However, likely the authors excluded participants with bacterial prostatitis and prostate tumours if based on diagnostic tests to identify chronic abacterial participants. Sample size: 54. Age (years): Mean age overall: 38.2 years (range 21 to 45); Group 1: 38.4; Group 2: 39.6; Group 3: 36.2. Baseline NIH‐CPSI score: not available. Sex: men. | |
Interventions | Group 1: 1 session of transrectal hyperthermia weekly for 4 weeks. Group 2: 1 session of transrectal hyperthermia weekly for 6 weeks. Group 3: 2 sessions of transrectal hyperthermia weekly for 3 weeks. 'The Prostathermer 99D system (Biodan Ltd, Rehovot, Israel) was used to deliver hyperthermia. The target temperature was reached within the first ten minutes of treatment and maintained throughout the whole session. Briefly, the system is composed of a rectal heat applicator with a source of microwaves at 915 MHz, and a series of thermosensors for monitoring rectal temperature, a cooling system for the anterior rectal wall, a specifically designed urethral catheter with three thermosensors for the assessment of prostatic urethra temperatures, and a computer system for data analysis and storage. Hyperthermia was administered on an outpatient basis and participants required only local anesthesia, with 2% xylocaine jelly before insertion of the catheter.' Cointerventions: all the participants received antibiotic therapy with doxycycline 100 mg twice daily for 2 weeks prior to trial. | |
Outcomes | Adverse events How measured: narratively. | |
Funding sources | None. | |
Declarations of interest | None. | |
Notes | Urinary symptoms measured using a modified Borsky scale (not a prespecified outcome of this review). | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: 'Patients were randomly assigned to three different therapeutic protocols, reported in Table 1.' No additional information provided. |
Allocation concealment (selection bias) | Unclear risk | No information available. |
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 | Low risk | All outcomes: outcome data available for all randomised participants. |
Selective reporting (reporting bias) | Unclear risk | Insufficient information for judgement. |
Other bias | Unclear risk | No information provided to compare the 3 groups on duration of symptoms. Authors measured subjective symptoms using a tool of uncertain validity (McNaughton 2001). |