Wille 2003.
| Methods | Randomised: yes Method of allocation: not described Blinding: not mentioned Dropouts: numbers participating at 3 and 12 months identified (for pad test, N = 116 at baseline, 79 at 3 months and 124 at 12 months), reason for dropouts not described | |
| Participants | Recruitment: pre‐operative Included: all men undergoing radical prostatectomy N = 139 randomised (number in each group at various data collection points varied) |
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| Interventions | Post‐operative intervention Group A (47): PFMT alone Group B (46): PFMT + ES; PFMT as above plus instructed by dedicated in ES via surface anal electrode and bio‐impulser (biphasic pulse with 1 second bursts, 5 second pulse width, 2 second pulse trains Group C (46): PFMT + ES + biofeedback. As above plus biofeedback (anal probe) 15 minutes twice daily for 3 months All groups A and B and C: PFMT by physiotherapist, 20‐30 minute sessions for 3 days, instructed to perform exercises twice daily for 3 months plus 3 week rehabilitation program after discharge. Regular interaction with health professional for 6 weeks after surgery, encouraged to performed treatment for 3 months post‐surgery Length of follow‐up: 12 months |
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| Outcomes | Main outcome: urine loss measure by continence questionnaire and 20 minute provocative pad test Continence definition: reported use of 0 to 1 pads on questionnaire (subjective) or loss of less than 1 gram of urine on pad test Data collection: baseline (after catheter removal), 3 months and 12 months post‐operatively Willingness to undergo surgery again: A 73%, B 83%, C 73% Quality of life EORCT QLQ‐C30: scores for physical; role; emotional; social; and global quality of life were not significantly different between the groups at 3 or 12 months (no SDs provided) No significant differences in continence rates between the three groups at baseline, 3 months or 12 months (objective) |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "Prospective randomized trial" Method of sequence generation not specified |
| Allocation concealment (selection bias) | Unclear risk | "Prospective randomized trial" Method of sequence generation not specified |
| 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 | Not reported |
| Incomplete outcome data (attrition bias) All outcomes | High risk | "Results at baseline after catheter removal, at 3 and 12 months postoperatively were available for 139, 120 and 128 (questionnaires at three different time points) and 116, 79 and 124 (pad test at three different time points) patients, respectively". However, no information about individual groups |
| 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 | Low risk | "Informed consent was obtained" |
| ITT analysis | Unclear risk | Not reported. Therefore judged to be unclear risk |