Methods |
Study design: parallel group randomised trial. Study dates: December 2003 to July 2004. Setting: outpatient, academic hospital. Country: South Korea. |
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Participants |
Inclusion criteria: aged ≥ 18 years with pelvic pain defined as pain in bladder, groin, genitals or lower abdomen or perineal or (peri)anal areas (or a combination) without clear abnormalities on urological examination, and ability to communicate, understand and comply with requirements of study. These participants had type IIIb CP/CPPS. Exclusion criteria: symptoms for < 6 months, acute or chronic urethritis, urinary stones, bacterial or inflammatory CP/CPPS, bladder cancer, prostate cancer, urethral strictures, neurogenic bladder dysfunction, restricted mobility and antimicrobial or anti‐inflammatory medication up to 4 weeks before enrolment in our study; documented history of prostatic intraepithelial neoplasia on biopsy, serum prostate‐specific antigen levels > 20 ng/mL, history of prostate surgery or radiotherapy and acute urinary retention or an indwelling catheter. Sample size: 40. Age (years): Group 1: 49 (range 41.5‐52); Group 2: 42 (28.8‐49.5). Baseline NIH‐CPSI score: Group 1: 17 (IQR 13 to 24); Group 2: 21 (IQR 15.8 to 30). Sex: men. |
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Interventions |
Group 1 (n = 21): terazosin (see cointerventions). Group 2 (n = 19): extracorporeal magnetic innervation using Neoconrol system (Neotonus Inc., Marietta, GA, USA) that generated a magnetic field directed in seat of chair and concentrated in region of pelvic muscles. 2 sessions weekly for 6 weeks, lasting 20 min each. The 1st 10 min used 10 Hz field, 2 min rest, and then an additional 10 min of 50 Hz field. Cointerventions: all participants received terazosin 2 mg/day for 1st 7 days, and continued to receive 4 mg daily for following 5 weeks. |
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Outcomes |
Prostatitis symptoms How measured: NIH‐CPSI score. Time points measured: before and after treatment (6 weeks). Time points reported: before and after treatment (6 weeks). Urinary symptoms How measured: IPSS score. Time points measured: before and after treatment (6 weeks). Time points reported: before and after treatment (6 weeks). Adverse events How measured: narratively. |
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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 | Quote: 'Patients were randomized according to the closed‐envelop method at a 1:1 ratio to either terazosin monotherapy.' Unclear what method was used for random sequence generation. |
Allocation concealment (selection bias) | Unclear risk | Quote: 'Patients were randomized according to the closed‐envelop method at a 1:1 ratio to either terazosin monotherapy.' Unclear whether they were opaque envelopes. |
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 | Protocol not available. |
Other bias | Low risk | No other sources of bias identified. |