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. 2018 Jan 26;2018(1):CD012551. doi: 10.1002/14651858.CD012551.pub2
Methods Study design: parallel group randomised trial.
Study dates: study dates not available.
Setting: outpatient.
Country: UK.
Participants Inclusion criteria: aged ≤ 70 years with diagnosis of CP/CPPS type IIIa or IIIb; each participant had previously undergone treatment with alpha‐blockers, antibiotics and several other therapies.
Exclusion criteria: prostate cancer, pelvic radiotherapy, positive culture in prostatic secretion.
Sample size: 21.
Age (years): overall 47.8 (range 25‐67).
Baseline NIH‐CPSI score: PSSI: Group 1 mean: 38.8; Group 2 mean: 39.3.
Sex: men.
Interventions Group 1 (n = 11): participants seated in Neotonus Electromagnetic Chair, for 2 consecutive 15‐min periods (1st period 10 Hz, 2nd period 50 Hz). Treatment included 2 sessions weekly for 4 weeks.
Group 2 (n = 10): participants seated in chair, ventilation mechanism activated, but no active stimulation applied.
Cointerventions: not available.
Outcomes Prostatitis symptoms
How measured: symptom questionnaire (9 items in a visual analogue scale, score 0 to 90); adapted from Nickel's questionnaire removing the digital rectal question (10 points). Pain and micturition subscores.
Time points measured: baseline, 3 months and 1 year.
Time points reported: baseline, 3 months and 1 year.
Adverse events
How measured: narratively.
Funding sources 'Neotonus™ provided the electromagnetic chair.'
Declarations of interest Not available.
Notes None.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: 'computer generated, blocked randomization.'
Allocation concealment (selection bias) Unclear risk No information available.
Blinding of participants and personnel (performance bias) Subjective outcomes Unclear risk Participants blinded using a sham procedure; however, no information regarding study personnel.
Blinding of outcome assessment (detection bias) All outcomes Low risk Quote: 'Patients were informed about the nature of the treatment, the treatment schedule and the possibility that they might be randomized to placebo but they were not given a detailed description of what local pelvic sensations, if any, to expect during treatment, so as not to bias blinding.'
Incomplete outcome data (attrition bias) All outcomes High risk Follow‐up data (all outcomes) available for all men. 11/11 in Group 1 and 7/10 in Group 2 (3 did not complete treatment) at 3 months. 8/11 in Group 1 and 5/10 in Group 2 at 1 year. Data on micturition subscore not available for Group 1.
Selective reporting (reporting bias) High risk Results presented without SD. Urinary scores at 1 year reported graphically in Group 1. Confidence intervals did not match central estimates.
Other bias Low risk No other sources of bias detected.