Heymen 1999.
Methods | Study design: randomised controlled trial Total study duration: no follow‐up beyond end of treatment |
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Participants | 36 patients referred to tertiary centre with pelvic floor dyssynergia, who required laxatives, enemas, digitation or combination to achieve bowel movement (26 female, 10 male) gender split between groups was not reported Age ‐ mean 61 years (range 18 to 82 years); duration of symptoms not reported Baseline comparability not reported |
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Interventions | Randomised to four groups All patients in intervention and comparison groups also educated as to normal bowel function, posture, not to prolong defecation attempts beyond 10 to 15 minutes, not to strain and to schedule bowel movements after meals or exercise Intervention group: Group 1: Weekly one hour EMG biofeedback ‐ use of intra‐anal sensor with EMG display of muscle activity Comparison groups: Group 2. EMG biofeedback plus balloon distention sensory training (using flexible manometry catheter with balloon attached and inflated up to 140 mL) 3. EMG biofeedback plus home trainer EMG biofeedback unit 4. EMG biofeedback plus balloon distention sensory training plus home trainer EMG biofeedback unit |
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Outcomes | Change in frequency of unassisted bowel movements (UBM) (meaning of UBM not defined) Laxative use |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not reported |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding (performance bias and detection bias) All outcomes | High risk | Not blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No attrition reported |
Selective reporting (reporting bias) | Unclear risk | Not registered on a clinical trials registry |
Other bias | High risk | Primary outcome was assessed by unblinded therapist making contact with patients by telephone |