Moore 2004.
| Methods | Randomised: yes (order of product testing: in threes to treatment block of 4 periods (1 no device, 3 with devices)
Block, multiple period cross‐over design using Latin square configuration
Method of allocation: sealed envelopes. Blinding: research assistant not involved in study chose envelope; but research assistant and participants could not be blinded to intervention Dropouts: none Intention to treat: not discussed |
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| Participants | Recruitment: post‐operative Included: men incontinent post‐radical prostatectomy who required continuous pad protection for stress incontinence Inclusion criteria: normal perineal and penile sensation, intact penile skin, sufficient manual dexterity Exclusion criteria: overactive bladder, neurological disorders affecting sensation or circulation, cognitive impairment. N = 12 men |
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| Interventions | Post‐operative intervention Each participant had 4 periods (each lasted 1 day) Group A: no device Group B: C3 device Group C: U‐Tex device Group D: Cunningham clamp |
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| Outcomes | Main outcome: 4 hour pad test Secondary outcomes: resistive index, cavernosal flow None of the devices completely eliminated urine loss when applied at a comfortable pressure. Each device showed improvement in terms of urine lost, with Cunningham clamp having the lowest mean loss Cunningham clamp significantly lowered flow, but ranked positively by participants |
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| Notes | Unable to blind participants and research assistant to intervention Sample size calculation given and required size achieved | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "A computer‐generated randomized list of device assignments was prepared by one of the investigators" Block, multiple period crossover design using Latin square configuration |
| Allocation concealment (selection bias) | Low risk | Sealed envelopes, research assistant not involved in study chose envelope |
| 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 | "A research assistant not directly involved with recruitment or data collection entered the data" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No dropouts |
| Selective reporting (reporting bias) | Low risk | Outcomes reported |
| Financial support | Low risk | "This study was supported by the University of Alberta Internal Allocations Fund and Department of Radiology, University of Alberta Hospital." |
| Approved by medical ethics committee | Low risk | "The Institutional review Board at the University of Alberta approved the study" |
| Informed consent | Low risk | "the study was explained and informed consent obtained" |
| ITT analysis | Unclear risk | Not specified. Therefore judged to be unclear risk |