Joseph 2000.
| Methods | Randomisation: yes Method of allocation: not described Blinding: none Dropouts: 3 did not return to clinic for all appointments, one had other health problems Intention to treat: no | |
| Participants | Recruitment: post‐operative Included: men incontinent post‐radical prostatectomy or post‐TURP. UI of at least 6 months duration N = 11 patients at least 6 months post‐surgery (4 radical retropubic, 6 radical peritoneal, 1 TURP) |
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| Interventions | Post‐operative intervention Group A (6): intervention: Instruction in PFMT including biofeedback with visual feedback as well as verbal to assist in identifying and discriminating muscles Group B (5): comparator: Instruction in PFMT, squeezing of finger during digital rectal examination Both: weekly visit for a total of 4 clinic visits Length of follow‐up: 12 months |
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| Outcomes | Main outcome: urine loss measure by standardised pad test, bladder diary, subjective estimation of degree of incontinence Secondary outcomes: leak point pressure measured by video‐urodynamics, Joseph Continence Assessment Tool Continence definition: subjective evaluation by participants Data collection: baseline, 3, 6, and 12 months No differences between the groups. Improvement seen in all patients at 12 months |
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| Notes | Data not published in article. Raw data supplied to review author (KFH) who calculated means and standard deviations. These were reviewed by a second review author (KNM) | |
| 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 | Reported as "Randomised". No additional information provided |
| Blinding of participants (performance bias) | High risk | Blinding to intervention not possible |
| Blinding of personnel (performance bias) | High risk | Blinding to intervention not possible |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported. Therefore judged to be unclear risk.\ |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Three dropouts |
| Selective reporting (reporting bias) | Unclear risk | Protocol not available |
| Financial support | Unclear risk | Not reported. Therefore judged to be unclear risk |
| Approved by medical ethics committee | Unclear risk | Not reported. Therefore judged to be unclear risk |
| Informed consent | Unclear risk | Not reported. Therefore judged to be unclear risk |
| ITT analysis | High risk | No |