| Methods | Study design: parallel group randomised trial. Study dates: June 2007 to December 2007. Setting: outpatient. Country: China. | |
| Participants | Inclusion criteria: aged ≥ 18 years, with course of disease of ≥ 3 months with an NIH‐CPSI pain subscore and urinary symptom subscore ≥ 1 who had received antibiotics, alpha‐blockers and NSAIDs treatment and were found ineffective. Exclusion criteria: history of urinary system infection in last 3 months, history of urinary or rectal tumour, neurological disease and narrowing of urinary tract or history of urinary tract surgery. Sample size: 140. Age (years): overall: 18˜48; mean: 30. Baseline NIH‐CPSI score: Group A: 25.82 (SD 2.34); Group B: 26.92 (SD 3.18); Group C: 26.35 (SD 2.19); Group D: 25.3 (SD 6.09). Sex: men. | |
| Interventions | Group A (n = 20): usual care (see cointerventions). Group B (n = 40): biofeedback. Display the EMG of the pelvic floor muscle to participant. Instruct participant on changes of EMG during contraction and relaxation of anus. Ask participant to contract (10˜20 seconds) and relax (10˜20 seconds) the anus according to instructions on display. Repeatedly for 20 min, 5 times each week; total 2 weeks. Group C (n = 40): electrical stimulation. Electrical stimulation by anal electrodes. Intensity: 6˜23 mA, stimulation 10˜20 seconds, relaxation 10˜20 seconds. Repeat the cycle for 20 min; 5 times each week; total 2 weeks. Group D (n = 40): biofeedback + electrical stimulation. Anus contraction (10˜20 seconds) ‐> relaxation (10˜20 seconds) ‐> electrical stimulation (Intensity: 6˜23 mA, 10˜20 seconds) ‐> relaxation (10˜20 seconds). Repeat the cycle for 20 min; 5 times each week; total 2 weeks. Cointerventions: avoid alcohol and spicy food; avoid sitting for too long and holding in urine; avoid catching a cold; be physically active and do exercise; have sex regularly; warm sitz bath regularly; discontinue any antibiotics, alpha‐blockers and other medications during the trial; persistence in pelvic floor muscle training. | |
| Outcomes | Prostatitis symptoms How measured: NIH‐CPSI global and subscore. Time points measured: before and 1 month after treatment. Time points reported: before and 1 month after treatment. Subgroups: none. Adverse events How measured: narratively. | |
| Funding sources | Not mentioned. | |
| Declarations of interest | Not mentioned. | |
| Notes | None. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Paper reported that 'patients were randomly assigned to …' However, we do not know what the method of randomisation was. |
| Allocation concealment (selection bias) | Unclear risk | Allocation concealment not described. |
| Blinding of participants and personnel (performance bias) Subjective outcomes | High risk | Paper did not report blinding of participants or personnel. However, the visible difference between the interventions made blinding unlikely. |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Blinding of outcome assessment not described. Self‐reported outcomes, participants not blinded. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | All outcomes: outcome data available for all participants. |
| Selective reporting (reporting bias) | Unclear risk | Unclear whether there was selective outcome reporting. |
| Other bias | Low risk | No other sources of bias identified. |