Mathewson‐Chapman 97.
| Methods | Randomised: yes, block procedure Method of allocation: not reported Blinding: none Dropouts: 2, not accounted for Intention to treat: not clear | |
| Participants | Recruitment: pre‐operative Included: all men undergoing radical prostatectomy N = 53 men Randomised pre‐operatively |
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| Interventions | Pre and post‐operative intervention Group A (27) intervention: pre‐operatively received further instruction and practice with PME protocol home exercises and biofeedback (anal probe) (Incare 8900); practiced at home 3 times a week, starting with daily 15 PFMT and increasing by 10 every 4 weeks to a maximum of 35 PFMT Group B (24) control: post‐operatively no further interventions until week 5 when pelvic muscle strength was assessed Both: pre‐operatively, both groups received 30 minutes' prostate education programme and baseline 'perineal muscle evaluation' (not defined); as well all were taught to contract the perineal muscle and hold for a few seconds prior to standing, lifting or coughing and limit the amount of tea, chocolate, alcohol and over‐the‐counter medications Length of follow‐up: 12 weeks |
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| Outcomes | Main outcome: urine loss measured by 24 hour pad test, frequency of micturitions (self‐recorded bladder diary), number of pads used; days to achieve continence from baseline Secondary outcomes: perineal muscle strength (method not described) Continence definition: self‐report of return of continence Data collection: 3 day bladder diaries at weeks 2, 5, 9 and 12. 24 hour pad test at weeks 5 and 12 |
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| Notes | Inclusion of other modalities such as caffeine limitation and using perineal muscles during any event which increased abdominal stress may have masked any treatment benefit Extra information obtained from thesis |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Block procedure |
| Allocation concealment (selection bias) | Unclear risk | No description. Therefore judged to be unclear risk |
| 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 | No description. Therefore judged to be unclear risk |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Two dropouts |
| Selective reporting (reporting bias) | Low risk | Outcomes in methods reported |
| Financial support | Unclear risk | Not reported |
| Approved by medical ethics committee | Low risk | "Permission to conduct this study was obtained from the Univerisity of Florida Health Center Institutional Review Board (IRB)." |
| Informed consent | Low risk | "The informed consent was explained to each subject, and his signature was obtained to confirm consent to participate in the study" |
| ITT analysis | Unclear risk | Not specified. Therefore judged to be unclear risk |