Methods |
Study design: parallel group randomised trial. Study dates: study dates not available. Setting: outpatient. Country: UK. |
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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. |
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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. |
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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. |
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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. |