title: 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.
  
  
  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
  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.
authors.affiliation: Division of Gerontology, Geriatrics and Palliative Care, Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.|Geriatric Research, Education, and Clinical Center, The Birmingham Veterans Affairs Medical Center, Birmingham, AL, USA.
authors.forename: A D
authors.initials: AD
authors.lastname: Markland
authors.affiliation: Obstetrics, Gynecology & Women's Health Institute, Cleveland Clinic, Cleveland, OH, USA.
authors.forename: J E
authors.initials: JE
authors.lastname: Jelovsek
authors.affiliation: Division of Gastroenterology and Hepatology, Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.|Division of Urogynecology, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
authors.forename: W E
authors.initials: WE
authors.lastname: Whitehead
authors.affiliation: Division of Urology, Department of Surgery, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.
authors.forename: D K
authors.initials: DK
authors.lastname: Newman
authors.affiliation: Department of Obstetrics and Gynecology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.
authors.forename: U U
authors.initials: UU
authors.lastname: Andy
authors.affiliation: Department of Obstetrics and Gynecology, Kaiser Permanente, San Diego, CA, USA.
authors.forename: K
authors.initials: K
authors.lastname: Dyer
authors.affiliation: Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, NC, USA.
authors.forename: I
authors.initials: I
authors.lastname: Harm-Ernandes
authors.affiliation: Departments of Obstetrics and Gynecology and Surgery, University of New Mexico Health Sciences Center, Albuquerque, NM, USA.
authors.forename: S
authors.initials: S
authors.lastname: Cichowski
authors.affiliation: Division of Gerontology, Geriatrics and Palliative Care, Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.|Geriatric Research, Education, and Clinical Center, The Birmingham Veterans Affairs Medical Center, Birmingham, AL, USA.
authors.forename: J
authors.initials: J
authors.lastname: McCormick
authors.affiliation: Department of Obstetrics and Gynecology, Alpert Medical School of Brown University, Providence, RI, USA.
authors.forename: C
authors.initials: C
authors.lastname: Rardin
authors.affiliation: Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.
authors.forename: G
authors.initials: G
authors.lastname: Sutkin
authors.affiliation: RTI International, Research Triangle Park, NC, USA.
authors.forename: A
authors.initials: A
authors.lastname: Shaffer
authors.affiliation: The Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD, USA.
authors.forename: S
authors.initials: S
authors.lastname: Meikle
mesh_terms: D001676:Biofeedback, Psychology / Q000379:methods*; D015928:Cognitive Behavioral Therapy / Q000379:methods* / Q000592:standards; D005242:Fecal Incontinence / Q000523:psychology* / Q000628:therapy*; D005260:Female; D006801:Humans; D008365:Manometry / Q000379:methods* / Q000592:standards; D016896:Treatment Outcome
keywords: anal sphincter exercises; anorectal manometry; factorial design; fecal incontinence; manometry-assisted biofeedback; pelvic floor disorders; randomized placebo-controlled trial; treatment fidelity; urge resistance training