Zhang 2007.
| Methods | Randomised: yes Method of allocation: not stated Blinding: none Dropouts: two did not complete the control follow‐up assessment because they believed the control group was not helpful |
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| Participants | 58 men approached, 33 consented, 3 dropouts Recruitment: post‐operative Included: all incontinent men 6 months after radical prostatectomy |
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| Interventions | Group A (14) intervention: PFMT plus BF using rectal electrical sensor, initial 45 minute session with physical therapist then written instructions to carry out at home three times a day for 10 minutes. Plus support group, 6 meetings in 3 months with a health psychologist Group B (15) control: PFMT plus BF using rectal electrical sensor, initial 45 minute session with physical therapist then written instructions to carry out at home three times a day for 10 minutes |
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| Outcomes | Length of follow‐up: 3 months Frequency of PFMT: 4 to 7 times per week A 12/14, B 6/13, P = 0.077 Use of pad or brief: A 7/14 (50%), B 11/13 (85%), P = 0.057 Not able to control urge to urinate and prevent leakage: A 4/14, B 8/13, P = 0.085 Nocturia per week (mean): A 13, B 15.08, P = 0.484 VAS for severity of UI: A 3.21, B 4.65, P = 0.057 (t = ‐1.902) QoL measured by Illness Intrusiveness Questionnaires (IIRS): A 10.96, B 17.27, P = 0.037 Mann Whitney U = 48.5 |
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| Notes | ||
| 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" |
| Blinding of participants (performance bias) | High risk | Group therapy (unable to blind to intervention) |
| Blinding of personnel (performance bias) | Unclear risk | A research assistant, who was a doctoral candidate in medical anthropology, collected data under supervision |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not specified. Therefore judged to be unclear risk |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Two dropouts in the control group |
| Selective reporting (reporting bias) | Low risk | Outcomes reported |
| Financial support | Low risk | "This study was supported by an American Cancer Society pilot research grant and the Frances Payne Bolton School of Nursing at Case Western Reserve University" |
| Approved by medical ethics committee | Unclear risk | Not reported. Therefore judged to be unclear risk |
| Informed consent | Unclear risk | "33 patients consented to participate" |
| ITT analysis | Unclear risk | Not reported. Therefore judged to be unclear risk |
ExMI = extra‐corporeal magnetic innervation; g = gram(s); PFMT = pelvic floor muscle training; TURP = transurethral resection of the prostate; UI = urinary incontinence