Marchiori 2010.
| Methods | RCT | |
| Participants |
Time of recruitment: post‐operative Population: men with incontinence after retropubic radical prostatectomy, open or laparoscopic Included: moderate to severe incontinence at 30 days after catheter removal Excluded: lack of cooperation, pre‐operative incontinence, early recovery of continence Age (mean): A 67; B 66.5 Dropouts: “Survey questionnaire were correctly filled in and returned by fewer than 10% of the patients” Baseline characteristics: comparable at baseline |
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| Interventions |
Time of intervention: post‐operative treatment A (166): one‐to‐one guided PFMT + biofeedback during first session, second session involved 10 sets of pelvic floor electrical stimulation lasting 15 mins each, instructed to: carry out three sets of 30 contractions a day at home for the first month after catheter removal (16 days after surgery) B (166): received oral and written information on pelvic floor anatomy and on PFME, instructed to: perform three sets of 30 contractions a day at home for the first month after catheter removal (16 days after surgery) and continue for duration of All men received oral and written information on pelvic floor anatomy and on PFME, pelvic floor muscle endurance assessed by digital anal control + PFMT consisting of 3 sets of 30 contractions daily for the first month after catheter removal Duration of treatment Follow up: 3 months, 6 months and 12 months |
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| Outcomes |
Primary outcome (number of men with UI) Number of incontinent men (defined as 0 or 2 minipads daily) 3 months: A 36/166; B 81/166 6.5 months: A 1/166; B 28/166 12 months: A 0/166; B 0/166 Other outcomes Median time of continence recovery, days: A 44 ± 2, B 76 ± 4, P ≤ 0.01 Quality of life ICIQ‐male: Results not reported RAND 36‐Item Health Survey questionnaire: results not reported |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | “Prospectively randomized” Sequence generation not reported |
| Allocation concealment (selection bias) | Unclear risk | "Prospectively randomized" |
| Blinding of participants (performance bias) | High risk | Blinding to intervention not possible |
| Blinding of personnel (performance bias) | High risk | Blinding to intervention not possible |
| 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 | High risk | Not reported for primary outcome |
| Selective reporting (reporting bias) | High risk | No reporting of primary outcome |
| Financial support | Unclear risk | Not reported. Therefore judged to be unclear risk |
| Approved by medical ethics committee | Unclear risk | Not reported. Therefore judged to be unclear risk |
| Informed consent | Unclear risk | Not reported. Therefore judged to be unclear risk |
| ITT analysis | Unclear risk | Not reported. Therefore judged to be unclear risk |