Yokoyama 2004.
| Methods | Randomised: yes Method of allocation: not stated Blinding: not mentioned Dropouts: it appears that there are no dropouts but this is not specifically mentioned |
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| Participants | Recruitment: post‐operative Included: 36 men with urinary incontinence, >100g on 24hour pad test, one day after catheter removal Mean age: Group A 67.2 years, Group B 68.2 years, Group C 66.2 years |
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| Interventions | A (12) intervention: anal electrode for 15 minutes twice a day for 1 month B (12) intervention: extra‐corporeal magnetic innervation, neocontrol system, treatment sessions 20 minutes, twice a week for 2 weeks C (12) control: PFMT, digital anal teaching of correct contractions, then verbal and written instructions for home practice Length of follow‐up: 2, 3, 4, 5 and 6 months |
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| Outcomes | 24 hour pad test weight (grams) 3 months: A 34 g, B 7.3 g, C 50 g. 6 months: for all groups less than 10 g Quality of life measured by I‐QOL: improvement in all groups over time, no statistically significant difference between the groups Remaining UI at 6 months: A 2/12, B 1/12, C 2/12 |
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| Notes | Adverse effects: None in any of the groups, no discomfort or irritation from anal probe | |
| 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 | Randomly assigned |
| Blinding of participants (performance bias) | Unclear risk | No description. Therefore judged to be unclear risk |
| 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 | Numbers not given |
| Selective reporting (reporting bias) | Unclear risk | Protocol not available |
| Financial support | Unclear risk | Not reported |
| Approved by medical ethics committee | Low risk | "The local ethics committee approved the protocol procedure" |
| Informed consent | Low risk | "Each patient provided written informed consent" |
| ITT analysis | Unclear risk | Not reported. Therefore judged to be unclear risk |