Ribeiro 2008.
| Methods | Randomised: yes | |
| Participants | Post‐operative intervention Included: radical prostatectomy, all men after catheter removal Age: 51 to 76 years |
|
| Interventions | Group A (36) intervention: PFMT plus BF weekly for 3 months Group B (37) control: PFMT oral instructions only Duration of treatment: weekly until continent or to a maximum of 3 months Length of follow‐up: 3 months after treatment finished |
|
| Outcomes | UI severity (24 hour pad test weights) 1 month (N, mean, SD): A 96 g (160) 36, B 355 (423) 37, P = 0.007 3 months: A 51 (119), 36, B 197 (269) 37 6 months: A 40 (77), 36, B 80 (176) 37 ICI‐SF score: 3 months:A 3.4 (3.7), 36, B 6.8 (5.6) 37, P = 0.022 6 months: A 2.7 (3.5), 36, B 4.3 (5.5) 37, P = 0.339 PFM Strength, A versus B: 1 month, P = 0.006; 3 months P < 0.001; 6 months P = 0.799 Quality of life (IIQ): 3 months: A 1.6 (2.7), 36, B 4.3 (6.2) 37 |
|
| Notes | Groups comparable at baseline before operation on age, BMI, voiding symptoms and PFMT strength | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No description. Therefore judged to be unclear risk |
| Allocation concealment (selection bias) | Unclear risk | "Randomised controlled trial" |
| Blinding of participants (performance bias) | High risk | Blinding to intervention not possible |
| Blinding of personnel (performance bias) | High risk | Blinding 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 | Low risk | 19: A:10 (2 refused further follow‐up, 7 post‐operative complications, 1 radiotherapy); B: 9 (6 refused further follow‐up, 2 post‐operative complications, 1 radiotherapy). No differential dropout |
| Selective reporting (reporting bias) | Low risk | Outcomes in methods reported |
| Financial support | Low risk | Grant FAPESP 2003/07656‐7 (Sao Paulo Research Foundation) |
| Approved by medical ethics committee | Low risk | "institutional review board approval" |
| Informed consent | Low risk | "All patients signed an informed consent before randomization" |
| ITT analysis | Low risk | Assumed from patient flow chart |