Overgard 2008.
| Methods | Randomised: yes | |
| Participants | Recruitment: Pre‐operative Included: radical prostatectomy, all men Age: Group A 48 to 68 years, Group B 49 to 72 years |
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| Interventions | Intervention: post operative Group A (38) intervention: instructions on PFMT and physiotherapy, 45 minutes weekly. Patients were instructed to perform 3 sets of contractions daily at home, in either a supine, sitting or standing position. Digital anal palpation to teach correct contractions, as well as oral and written instructions DVD of instructions given to those living too far from hospital Group B (42) control: instructions on PFMT alone Duration of treatment: up to 1 year Length of follow‐up: 3, 6 and 12 months |
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| Outcomes | Self‐reported continence (not using pads) 3 months: A 16/35 (46%), B 17/40 (43%), P = 0.73 6 months: A 27/34 (79%), B 22/38 (58%), P = 0.061 12 months: A 33/36 (92%), B 28/39 (72%), P = 0.028 24 hour pad test: g/24hrs, mean (range) 3 months: A 17 (0‐282), B 7 (0‐46), P = 0.53 6 months: A 9 (0‐203), B 2 (0‐12), P = 0.73 12 months: A 2 (0‐55), B 1 (0‐14), P = 0.95 PFM strength (anal squeeze pressure, cm H2O), mean (SD) 3 months: A 50.7 (23.9), B 55.7 (25.6), P = 0.398 6 months: A 56.1 (21.7), B 65.8 (27.0), P = 0.117 12 months: A 64.0 (24.0), B 71.5 (26.2), P = 0.237. |
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| Notes | No SDs | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Norwegian University performed the computerised randomisation procedure immediately after pre‐operative test |
| Allocation concealment (selection bias) | Low risk | Norwegian University performed the computerised randomisation procedure immediately after pre‐operative test. Urologist no prior knowledge of randomisation procedure |
| 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 | No information. Therefore judged to be unclear risk |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Drop out rate was 6% Four lost to follow up in physiotherapy group, one lost in instructions only group |
| Selective reporting (reporting bias) | Low risk | Outcomes in methods reported |
| Financial support | Low risk | "The work was funded by The Norwegian Fund for Postgraduate Training in Physiotherapy and The Norwegian Cancer Society" |
| Approved by medical ethics committee | Low risk | "The study was approved by the Regional Committee for Medical and Health Research Ethics" |
| Informed consent | Low risk | "Eighty‐five men provided written informed consent" |
| ITT analysis | Low risk | Assumed from patient flow chart |