Symptom Outcomes Important to Women With Anal Incontinence: A Conceptual Framework

Sung, Vivian W. MD, MPH; Rogers, Rebecca G. MD; Bann, Carla M. PhD; Arya, Lily MD; Barber, Matthew D. MD, MHS; Lowder, Jerry MD; Lukacz, Emily S. MD, MAS; Markland, Alayne DO; Siddiqui, Nazema MD, MHS; Wilmot, Amanda BSc; Meikle, Susan F. MD, MSPH; for the Pelvic Floor Disorders Network

doi: 10.1097/AOG.0000000000000236
Contents: Original Research

OBJECTIVE: To develop a framework that describes the most important symptom outcomes for anal incontinence treatment from the patient perspective.

METHODS: A conceptual framework was developed by the Pelvic Floor Disorders Network based on four semistructured focus groups and confirmed in two sets of 10 cognitive interviews including women with anal incontinence. We explored: 1) patient-preferred terminology for describing anal incontinence symptoms; 2) patient definitions of treatment “success”; 3) importance of symptoms and outcomes in the framework; and 4) conceptual gaps (defined as outcomes not previously identified as important). Sessions were conducted according to grounded theory transcribed, coded, and qualitatively and quantitatively analyzed to identify relevant themes. Content and face validity of the framework were further assessed using cognitive interviews.

RESULTS: Thirty-four women participated in focus groups and 20 in cognitive interviews. Overall, 29 (54%) were aged 60 years or older, 42 (78%) were white, and 10 (19%) had a high school degree or less. Two overarching outcome themes were identified: “primary bowel leakage symptoms” and “ancillary bowel symptoms.” Subdomains important in primary bowel leakage symptoms included leakage characteristics (symptom frequency, amount of leakage, symptom bother) and conditions when bowel leakage occurs (predictability, awareness, urgency). Subdomains important under ancillary bowel symptoms included emptying disorders (constipation, obstructed defecation, and wiping issues) and discomfort (pain, burning). New outcomes identified included predictability, awareness, wiping issues, and discomfort.

CONCLUSION: Women with anal incontinence desire a wide range of symptom outcomes after treatment. These are captured in our conceptual framework, which can aid clinicians and researchers in assessing anal incontinence.

LEVEL OF EVIEDENCE: II

Women with accidental bowel leakage experience and desire the assessment of a wide range of symptom outcomes, which are captured in our conceptual framework.

Division of Urogynecology and Reconstructive Pelvic Surgery, Department of Obstetrics and Gynecology, Alpert Medical School of Brown University, Providence, Rhode Island; the Division of Urogynecology, Department of Obstetrics and Gynecology, University of New, Mexico, Albuquerque, New Mexico; the Program for Research in Survey Methodology, RTI International, Research Triangle Park, North Carolina; the Division of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Pennsylvania Health System Department, Philadelphia, Pennsylvania; the Center for Urogynecology and Reconstructive Pelvic Surgery, Obstetrics, Gynecology and Women's, Health Institute, Cleveland Clinic, Cleveland, Ohio; the Women's Center for Bladder and Pelvic Health, Department of Obstetrics and Gynecology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania; the Department of Reproductive Medicine, UC San Diego Health Systems, San Diego, California; the Birmingham and Atlanta Geriatric Research, Education, and Clinical Center, Department of Veterans Affairs Medical Center, Division of Gerontology, Geriatrics, and Palliative Care, Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama; the Division of Urogynecology, Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, North Carolina; and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.

Corresponding author: Vivian W. Sung, MD, MPH, Division of Urogynecology and Reconstructive Pelvic Surgery, Women and Infants' Hospital and Warren Alpert Medical School at Brown University, 695 Eddy Street, Lower Level, Providence, RI 02903; e-mail: vsung@wihri.org.

Supported by National Institutes of Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development grants K23HD060665 (Principal Investigator: Sung) and HD054215, HD041261, HD041267, HD069010, HD069013, HD069006, HD054214, HD069025, HD069031, and the National Institutes of Health Office of Research on Women's Health.

Presented at the American Urogynecologic Society 34th Annual Scientific Meeting, October 16–19, 2013, Las Vegas, Nevada.

Financial Disclosure Dr. Rogers is a data safety monitoring board chair for the TRANSFORM trial, sponsored by American Medical Systems. She receives royalties from UpToDate for her chapter on pelvic organ prolapse. Dr. Lukacz has been a consultant and received research grants from Renew Medical, Inc, and Pfizer. She has received a research grant from Boston Scientific, has been a consultant to AMS, and she has received a stipend for continuing medical education program development from MedEdicus. She has also received an educational grant from Johnson & Johnson and Ethicon; research grant support from the National Institutes of Health (NIH) and the Eunice Kennedy Shriver National Institute of Child Health and Human Development; research grant support, travel reimbursement, and honoraria from the NIH and the National Institute of Diabetes and Digestive and Kidney Diseases; research funding from AUGS; and medicolegal expert witness fees from various sources. The other authors did not report any potential conflicts of interest.

© 2014 by The American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.