Morihiro 2011.
| Methods | RCT abstract only | |
| Participants |
Time of recruitment: not reported Population: men having laparoscopic radical prostatectomy Included: patients who underwent laparoscopic radical prostatectomy performed by a single surgeon Excluded: not reported Age (mean, SD): not reported Dropouts: not reported Baseline characteristics: comparable at baseline |
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| Interventions |
Time of intervention: post‐operative treatment for all men A (20): PFMT + sacral surface therapeutic ES (ssTES), ssTES 2 times a day for 15 minutes each, lasting 1 month after catheter removal (day 5) B (14): PFMT only, carried out alone Duration of treatment: 1 month Follow‐up: 1 month, 3 months, 6 months and 12 months post‐operatively |
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| Outcomes |
Primary outcome (number of men with UI) Number of incontinent men (defined as requirement for a pad to keep clothing dry) 6 months: A 3/20; B 6/14 12 months: A 0/20; B 5/14 Other outcomes Recovery rate of urinary continence (defined as no requirement for a pad to keep clothing dry) 6 months: A 17/20, B 8/14 12 months: A 20/20, B 9/14, P = 0.007 Quality of life |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | “randomly assigned” |
| Allocation concealment (selection bias) | Unclear risk | "randomly assigned" |
| Blinding of participants (performance bias) | High risk | Blinding to intervention not possible |
| Blinding of personnel (performance bias) | Unclear risk | No description. Therefore judged to be unclear risk |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No description. Therefore judged to be unclear risk |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Not enough information. 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 | “ethics committee of Kitasato university of medicine” |
| Informed consent | Low risk | Yes |
| ITT analysis | Unclear risk | No description. Therefore judged to be unclear risk |