Methods |
Study design: parallel group randomised trial. Study dates: 2003‐2005. Setting: academic hospital, outpatient. Country: Germany. |
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Participants |
Inclusion criteria: aged 18‐70 years, referred by urologists properly assessed with full examination. Exclusion criteria: chronic diseases (autoimmune, neoplastic, metabolic disease, benign hyperplasia, chronic cystitis), surgery in the lower abdomen. Sample size: 35. Age (years): Group 1: 46.4 (SD 12.6); Group 2: 47.9 (SD 8.2). Baseline NIH‐CPSI score: Group 1 22.85 (SD 6.89); Group 2: 22.95 (SD 8.46). Sex: men. |
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Interventions |
Group 1 (n = 20): osteopathic treatment based of osteopathic theory of structural dysfunction; involved direct techniques (e.g. manipulation, mobilisation, muscle energy techniques, myofascial approaches) and indirect techniques (functional techniques, visceral techniques and cranial techniques). Prostate, coccygeal and rectal disorders were treated internally (rectal) and externally. Involved 5 × 45‐minute sessions distributed in weeks 1, 2, 3, 5 and 8. Group 2 (n = 15): sham exercise programme with period of warm up, stretching, limb exercises, breathing exercises and pelvic floor exercise. Participants received 5 × 30‐minute sessions. Cointerventions: no other treatments allowed. Only medication prior to commencement of urogenital symptoms. |
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Outcomes |
Prostatitis symptoms How measured: NIH‐CPSI score and quality of life subscore. Time points measured: baseline, 8 weeks (end of treatment), 6 weeks' follow‐up after treatment and 1.5 years later (this time point only Group 1). Time points reported: baseline, 8 weeks (end of treatment), 6 weeks' follow‐up after treatment and 1.5 years later (this time point only Group 1). Urinary symptoms How measured: IPSS. Time points measured: baseline, 8 weeks (end of treatment), 6 weeks' follow‐up after treatment and 1.5 years later (this time point only Group 1). Time points reported: baseline, 8 weeks (end of treatment), 6 weeks' follow‐up after treatment and 1.5 years later (this time point only Group 1). |
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Funding sources | Not available. | |
Declarations of interest | Authors declared no conflict of interests. | |
Notes | There was a 5‐year report of this trial but only of intervention arm. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated sequence. |
Allocation concealment (selection bias) | Low risk | Central allocation. |
Blinding of participants and personnel (performance bias) Subjective outcomes | High risk | Participants and personnel not blinded. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Participants not blinded. |
Incomplete outcome data (attrition bias) All outcomes | High risk | All outcomes: no outcome data for 2/15 participants in Group 2, whereas outcome data available for 20/20 participants in Group 1 (unbalanced attrition). |
Selective reporting (reporting bias) | Unclear risk | Protocol not available. |
Other bias | Low risk | No other sources of bias identified. |