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. 2014 Mar 26;2014(3):CD008486. doi: 10.1002/14651858.CD008486.pub2

Heymen 1999.

Methods Study design: randomised controlled trial
Total study duration: no follow‐up beyond end of treatment
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
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
Outcomes Change in frequency of unassisted bowel movements (UBM) (meaning of UBM not defined)
Laxative use
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