Glazener RP 2011.
| Methods | RCT | |
| Participants | Recruitment: post‐operative Included: men with persistent urinary incontinence at 6 weeks after radical prostatectomy Excluded: radiotherapy planned; unable to comply with study or intervention; previous formal PFMT Age (mean, SD): A 62.4 (5.8); B 62.3 (5.6) |
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| Interventions | A (205): one‐to‐one therapy sessions including PFMT and BT if OAB or urgency symptoms + PFMT and lifestyle leaflet Duration of treatment: 4 sessions in 3 months starting 6 weeks after surgery B (206): control group with standard care + lifestyle leaflet only, no individual PFMT instruction or sessions |
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| Outcomes | UI defined as positive response to ICIQ‐SF questionnaire UI at 3 months: A 172/200, B 176/198 UI at 6 months: A 158/197, B 158/197 UI at 9 months: A 144/191, B 157/194 UI at 12 months: A 148/196, B 151/195 Severe UI at 12 months: A 74/196, B 78/195 UI episodes at 12 months from diaries (mean (SD N): A 3 (3.8) 105, B 2.9 (3) 106 ICI‐Q score at 12 months (mean (SD N): A 4.9 (4.1) 196, B 5.4 (4.5) 195 QoL due to UI at 12 months (mean (SD N): A 1.4 (2) 193, B 1.7 (2.3) 193 Use of pads at 12 months: A 63/159, B 68/161 Men not doing PFMT at 12 months: A 63/191, B 91/189 Erectile dysfunction (no erection): A 105/189, B 105/190 QALYs virtually identical Cost: NHS intervention cost was GBP 181 higher in intervention group (95% CI 107 to 255) Other outcomes: use of other protection, catheters, sheath catheters, urinary frequency, nocturia, faecal incontinence, urgency, constipation, EQ5D, SF‐12 |
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| Notes | Low dropout rates ICI‐Q score: 0 = no UI, no effect on QoL; 21 = maximum amount, frequency and effect on QoL QoL due to UI measured using ICIQ‐SF: 0 = no effect, 10 = maximum effect Compliance with therapy high |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer generated, minimised on centre, age and pre‐existing urinary incontinence |
| Allocation concealment (selection bias) | Low risk | Remote computer allocation |
| Blinding of participants (performance bias) | High risk | Blinding to intervention not possible for men |
| Blinding of personnel (performance bias) | High risk | Blinding to intervention not possible for therapists |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Outcomes from questionnaires completed by men, data entry clerks blinded to group |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No differential dropout from the groups |
| Selective reporting (reporting bias) | Low risk | Outcomes in methods were reported |
| Financial support | Low risk | "The trial was funded by the National Institute of Health Research Health Technology Assessment (NIHR HTA) Programme (project number 03‐14‐03) and will be published in full in Health Technology Assessment. HSRU, HERU, and NMAHP RU are funded by the Chief Scientist Office of the Scottish Government Health Directorates" |
| Approved by medical ethics committee | Low risk | "Our trials were approved by the Multicentre Research Ethics Committee, Edinburgh, Scotland and overseen by an independent trial steering committee and a separate independent data monitoring committee" |
| Informed consent | Low risk | "All men gave signed informed consent" |
| ITT analysis | Low risk | "We used intention‐to‐treat analysis" |