Skip to main content
. 2018 Jan 26;2018(1):CD012551. doi: 10.1002/14651858.CD012551.pub2
Methods Study design: parallel group randomised trial.
Study dates: December 2003 to July 2004.
Setting: outpatient, academic hospital.
Country: South Korea.
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.
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.
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.
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.