Robinson 2009.
Methods | Randomisation: randomly assigned via sealed envelopes | |
Participants | Number of men 54 but no numbers in groups Recuitment: post‐operatively Included: radical prostatectomy, all with UI who were 50 + years, English speaking and were within a 50 mile radius of treatment centre Age: mean 59.5 (6.3) years |
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Interventions | Group A intervention: routine brief verbal and written PFMT plus one PFMT session and 3 weekly nurse phone calls Group B intervention: routine brief verbal and written PFMT plus four BF enhanced PFMT sessions and 4 weekly nurse phone calls Group C control: routine brief verbal and written PFMT Duration of treatment: 3 months Length of follow‐up: 9 months |
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Outcomes | Urine stream interruption test (PFM strength) Mishell Uncertainty in Illness Scale Broome Pelvic Muscle self‐Efficacy Scale UI frequency (3 day bladder diary) 24 hour pad test (volume of urine lost) Male Urogenital Distress Inventory (UI distress) Male Urinary Symptom Impact Questionnaire (QoL) |
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Notes | No useable data in abstract | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Via sealed envelopes |
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 | No description. Therefore judged to be unclear risk |
Selective reporting (reporting bias) | Unclear risk | Protocol not available |
Financial support | Low risk | "NIH/NINR" |
Approved by medical ethics committee | Low risk | "Yes" |
Informed consent | Low risk | "Following informed consent" |
ITT analysis | Unclear risk | Not specified. Therefore judged to be unclear risk |