McHugh 1986.
Methods | Randomised controlled trial. Analysis: unclear if intention to treat. Allocation: randomised to biofeedback or exercises, cross‐over design. |
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Participants | Setting and country: single centre, Canada. Inclusion criteria: regular and frequent (more than 8 of 28 days) "idiopathic" FI. Exclusion criteria: 93 patients who responded to initial dietary manipulation excluded. Number of participants: 18. 5 of 18 dropped out (all from exercise group) Age: mean 55.2 ± 11.4 years |
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Interventions | Biofeedback ‐ standardised protocol ‐ 3 sessions over 2 months. No details given. Exercises: Daily voluntary sphincter exercise programme using a home manometer. | |
Outcomes | Daily diaries of stains, accidents and stools Follow‐up period: 8 months study duration. |
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Notes | Abstract only. Insufficient data to allow statistical analyses. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No mention |
Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | No mention of blinding |
Incomplete outcome data (attrition bias) All outcomes | High risk | 5 of 18 dropped out (all from exercise group) |