Goode 2009.
| Methods | Randomised controlled trial | |
| Participants | Recruitment: post‐operative Included: men incontinent 1 to 16 years after radical prostatectomy (mean years since operation: A 5.1, B 3.9, C 5.1) N = 208 (prior to dropout). Analysis of 172 men at 8 weeks Age between 51 to 84 years % of men with prior PFMT instruction: A 36%, B 56%, C 47% % of men using antimuscarinics: A 16%, B 20%, C 28% % of men with urgency UI: A 1%, B 3%, C 2% % of men with stress UI: A 44%, B 47%, C 44% % of men with mixed UI: A 54%, B 50%, C 54% |
|
| Interventions | A (70): behavioural therapy with PFMT alone for 8 weeks B (70): behavioural therapy with biofeedback and electrical stimulation for 8 weeks C (68): control, no treatment for 8 weeks, then offered choice of intervention A or B Behavioural therapy consisted of pelvic floor muscle exercises and bladder control strategies in both groups Dropouts: A 19 at 6 months, 23 at 12 months; B 22 at 6 months, 36 at 12 months; C 3 at 8 weeks Length of follow‐up: 12 months for groups A and B C transferred to treatment at 8 weeks so no further follow up possible |
|
| Outcomes | Frequency of UI, mean accidents in a week Number of continent men at 8 weeks: A 11/70, B 12/70, C 4/68 Incontinence episodes per day at 8 weeks (mean, SD, N): A 1.86 (0.56) 58; B 1.71 (0.54) 54; C: 3 (1.17) 64 Change in quality of life at 8 weeks using EPIC UI subscale (bigger change is better, mean, SD, N): A 13.1 (15.5) 58; B 12.3 (14.6) 54; C 2.9 (12.4) 64 Adverse events: A 0/70, B 2/70 (haemorrhoidal irritation), C 0/68 Patient's Global Perceptions of Improvement (much better): A 90%, B 91%, C 10% Completely satisfied with treatment progress: A 47%, B 47%, C not reported Compliance with PFMT and bladder control strategies at 8 weeks: A 100%, B 93% Compliance at 6 months: A 82%, B 84% Compliance at 12 months: A 91%, B 81% |
|
| Notes | Some baseline differences between groups, did not quite reach statistical significance High dropout rates No data available for control group after eight weeks as all received treatment |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Stratified by site, type and frequency of UI, generated by computer programme |
| Allocation concealment (selection bias) | Low risk | Sealed envelopes, opened sequentially |
| Blinding of participants (performance bias) | High risk | Blinding to intervention not possible |
| Blinding of personnel (performance bias) | Unclear risk | Data entry staff blinded to group |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Outcomes from questionnaires completed by men, data entry staff blinded to group |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Analysis and reported tables on 172 men |
| Selective reporting (reporting bias) | Low risk | Results of outcomes reported |
| Financial support | Low risk | National Institutes of Health ‐ National Institute of Diabetes and Digestive and Kidney Diseases, grant R01 DK60044‐01A2 |
| Approved by medical ethics committee | Low risk | Approved by "University of Alabama at Birmingham Institutional Review Board" |
| Informed consent | Low risk | Yes |
| ITT analysis | Unclear risk | Not specified |