Solomon 2003.
Methods | Randomised controlled trial. Analysis: not intention to treat. |
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Participants | Setting and country: single centre, Australia. Inclusion criteria: failed dietary and medical treatment. Exclusion criteria: No anatomic defect in external sphincter, IBD, peri‐anal inflammation, diarrhoea, rectal prolapse. Number of participants: 120 randomised, 102 completed Age: mean age 62 years Sex:107 women, 13 men Other characteristics of participants: |
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Interventions | Five thirty minute sessions over four months. Group 1: Anal sphincter exercises taught on digital examination. Group 2: Anal sphincter exercises taught with transanal ultrasound feedback. Group 3: Anal sphincter exercises taught with manometric feedback. | |
Outcomes | Scores, VAS, investigators assessment, quality of life, manometry, fatigue rate Follow‐up period: end of treatment. |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Opaque envelopes organised centrally |
Allocation concealment (selection bias) | Low risk | Opaque envelopes organised centrally |
Blinding (performance bias and detection bias) All outcomes | Low risk | Outcome assessor blinded |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 120 randomised, 102 completed (groups not stated) |