Improving biofeedback for the treatment of fecal incontinence in women: implementation of a standardized multi-site manometric biofeedback protocol

Abstract

Background: Standardized training and clinical protocols using biofeedback for the treatment of fecal incontinence (FI) are important for clinical care. Our primary aims were to develop, implement, and evaluate adherence to a standardized protocol for manometric biofeedback to treat FI. Methods: In a Pelvic Floor Disorders Network (PFDN) trial, participants were enrolled from eight PFDN clinical centers across the United States. A team of clinical and equipment experts developed biofeedback software on a novel tablet computer platform for conducting standardized anorectal manometry with separate manometric biofeedback protocols for improving anorectal muscle strength, sensation, and urge resistance. The training protocol also included education on bowel function, anal sphincter exercises, and bowel diary monitoring. Study interventionists completed online training prior to attending a centralized, standardized certification course. For the certification, expert trainers assessed the ability of the interventionists to perform the protocol components for a paid volunteer who acted as a standardized patient. Postcertification, the trainers audited interventionists during trial implementation to improve protocol adherence. Key Results: Twenty-four interventionists attended the in-person training and certification, including 46% advanced practice registered nurses (11/24), 50% (12/24) physical therapists, and 4% physician assistants (1/24). Trainers performed audio audits for 88% (21/24), representing 84 audited visits. All certified interventionists met or exceeded the prespecified 80% pass rate for the audit process, with an average passing rate of 93%. Conclusions & Inferences: A biofeedback protocol can be successfully imparted to experienced pelvic floor health care providers from various disciplines. Our process promoted high adherence to a standard protocol and is applicable to many clinical settings.

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Published Version (Please cite this version)

10.1111/nmo.12906

Publication Info

Markland, AD, JE Jelovsek, WE Whitehead, DK Newman, UU Andy, K Dyer, I Harm-Ernandes, S Cichowski, et al. (2017). Improving biofeedback for the treatment of fecal incontinence in women: implementation of a standardized multi-site manometric biofeedback protocol. Neurogastroenterology and Motility, 29(1). 10.1111/nmo.12906 Retrieved from https://hdl.handle.net/10161/15119.

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Jelovsek

John E Jelovsek

F. Bayard Carter Distinguished Professor of Obstetrics and Gynecology

Dr. Jelovsek is the F. Bayard Carter Distinguished Professor of OBGYN at Duke University and serves as Director of Data Science for Women’s Health. He is Board Certified in OBGYN by the American Board of OBGYN and in Female Pelvic Medicine & Reconstructive Surgery by the American Board of OBGYN and American Board of Urology. He has an active surgical practice in urogynecology based out of Duke Raleigh. He has expertise as a clinician-scientist in developing and evaluating clinical prediction models using traditional biostatistics and machine learning approaches. These “individualized” patient-centered prediction tools aim to improve decision-making regarding the prevention of lower urinary tract symptoms (LUTS) and other pelvic floor disorders after childbirth (PMID:29056536), de novo stress urinary incontinence and other patient-perceived outcomes after pelvic organ prolapse surgery, risk of transfusion during gynecologic surgery, and urinary outcomes after mid-urethral sling surgery (PMID: 26942362). He also has significant expertise in leading trans-disciplinary teams through NIH-funded multi-center research networks and international settings. As alternate-PI for the Cleveland Clinic site in the NICHD Pelvic Floor Disorders Network, he was principal investigator on the CAPABLe trial (PMID: 31320277), one of the largest multi-center trials for fecal incontinence studying anal exercises with biofeedback and loperamide for the treatment of fecal incontinence. He was the principal investigator of the E-OPTIMAL study (PMID: 29677302), describing the long-term follow up sacrospinous ligament fixation compared to uterosacral ligament suspension for apical vaginal prolapse. He was also primary author on research establishing the minimum important clinical difference for commonly used measures of fecal incontinence. Currently, he serves as co-PI in the NIDDK Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN) (U01DK097780-05) where he has been involved in studies in the development of Symptoms of Lower Urinary Tract Dysfunction Research Network Symptom Index-29 (LURN SI-29) and LURN SI-10 questionnaires for men and women with LUTS. He is also the site-PI for the PREMIER trial (1R01HD105892): Patient-Centered Outcomes of Sacrocolpopexy versus Uterosacral Ligament Suspension for the Treatment of Uterovaginal Prolapse.


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