Ghanem 2013.
Methods | RCT | |
Participants |
Time of recruitment: pre‐operative Population: 100 men undergoing a radical prostatectomy (whole population, with or without UI) Included: men undergoing RP for clinically localized prostate cancer. Excluded: patients who had previous pelvic organ surgeries, patients with central or peripheral neurologic diseases Age (mean, SD): not reported Dropouts: not reported Baseline characteristics: not reported |
|
Interventions |
Time of intervention: pre‐operative (post‐operative treatment for all men) A (50): pre‐operative PFMT for 2 weeks + post‐operative PFMT programme B (50): post‐operative PFMT programme only Duration of treatment Follow‐up: 3.5, 4.5, 12, 13 and 13.5 months |
|
Outcomes |
Primary outcome (number of men with UI) Number of incontinent men (defined as using > 1 pad on pad test) 12 months: A 2/50; B 3/50 13 months: A 2/50; B2/50 Other outcomes Quality of life ICS male SF questionnaire, results not reported |
|
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | “Patients were divided randomly” |
Allocation concealment (selection bias) | Unclear risk | Not reported. Therefore judged to be unclear risk |
Blinding of participants (performance bias) | High risk | Blinding to treatment not possible |
Blinding of personnel (performance bias) | Unclear risk | Not reported. Therefore judged to be unclear risk |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported. Therefore judged to be unclear risk |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Not reported. Therefore judged to be unclear risk |
Selective reporting (reporting bias) | Unclear risk | Protocol not available. Therefore judged to be unclear risk |
Financial support | Low risk | None |
Approved by medical ethics committee | Low risk | “Faculty of Physical Therapy Ethical committee, Cairo University” |
Informed consent | Low risk | Yes |
ITT analysis | Unclear risk | Not specified |