Hoffman 2005.
| Methods | Randomised: yes Method of allocation: computerised randomisation Blinding: unclear Dropouts: 1 participant from each intervention group had dropped out by discharge; 15 dropouts from the perineal group, 31 from the anal group and 5 from the control group dropped out by 3 months Intention to treat: no | |
| Participants | Recruitment: post‐operative Included: men incontinent post‐radical prostatectomy in an inpatient rehabilitation program N= 180 men (prior to dropouts). Randomly assigned to 3 groups (60 in each group) |
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| Interventions | Post‐operative intervention
Group A (60) intervention: perineal ES plus physiotherapy (PFMT) Group B (60) intervention: anal ES plus physiotherapy (PFMT) Group C (60) control: PFMT alone. Length of follow‐up: 3 months |
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| Outcomes | Main outcome: urine loss measure on 1 hour pad test Secondary outcomes: quality of life (QLQ‐C30) Continence definition: self‐reports of incontinence Data collection: admission and discharge from the rehabilitation program and at 3 months after discharge All groups improved on continence and quality of life. Use of ES was only of additional value in a compliant subgroup. Perineal ES was better accepted than anal |
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| Notes | Additional data supplied to KFH by author | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Computerised randomisation |
| Allocation concealment (selection bias) | Unclear risk | Method of allocation concealment not specified |
| Blinding of participants (performance bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of personnel (performance bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Insufficient information to permit judgement |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Dropouts: 22 out of 60 in anal ES group, 4 out of 60 in perineal ES group. No reasons for dropouts given |
| Selective reporting (reporting bias) | Unclear risk | Protocol not available |
| 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 | High risk | No intention‐to‐treat analysis; insufficient information on methods of statistical analysis; interventions unclear and insufficiently specified |