Purpose The purposes of this study were: (1) to examine the efficacy of anorectal biofeedback (AB) for constipation compared to a biofeedback control (BC) treatment and (2) to examine the extent to which self-reported childhood sexual/physical abuse predicted biofeedback outcome. Methods Twenty-one patients with pelvic floor dyssynergia were randomized to either (1) an AB arm, where patients learned to isolate the anal sphincter using an electromyog-raphy probe, or (2) a BC arm that controlled for the nonspecific effects of biofeedback, where patients learned to relax trapezius or temporalis muscles with EMG feedback. Both treatments were delivered by registered nurses for six sessions. Prior to randomization and post-treatment, patients completed the validated Constipation Severity Instrument and two measures of quality of life (QOL), the Irritable Bowel Syndrome-QOL, and the SF-36. Generalized estimating equations examined the within-group and between-group differences over time. Results Pre- and post-treatment data were obtained for six AB and nine BC patients. AB patients' overall constipation severity scores decreased by 35.5% (vs. 15.3%), and their obstructive defecation symptom scores decreased by 37.9% (vs. 19.7%) compared to BC. A similar pattern was shown on the IBS-QOL. On the SF-36 Mental Health Composite (MCS), AB scores improved 28.0% compared to BC scores, which worsened 12.7%. Those without (vs. with) a childhood sexual/physical abuse history showed improvement on the MCS post-biofeedback. Conclusions While our sample was statistically underpowered, AB produced clinical improvements in constipation severity and QOL.
Bibliographical noteFunding Information:
Tx treatment, AB anorectal biofeedback group, BC biofeedback control group, CSI constipation severity instrument, CSI OD constipation severity instrument obstructive defecation subscale, MCS SF-36 mental health composite scale Acknowledgments This clinical trial was registered at clinicaltrials. gov under NCT00502957. Support for this research comes from a Research Evaluation and Allocation Committee grant from the University of California, San Francisco, awarded to Dr. Varma. There are no financial relationships to disclose for any of the authors.
- Anorectal biofeedback
- Clinical trial
- Quality of life