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Does combining perioperative behavioral and pelvic floor muscle therapy with midurethral sling result in greater improvement in mixed urinary incontinence symptoms than does a sling alone?
In this randomized clinical trial that included 480 women, incontinence symptoms (measured by the Urogenital Distress Inventory Long Form; range, 0-300 points; minimal clinically important difference, 35 points) decreased by 128.2 points in the combined therapy group and 114.7 points in the surgery alone group, resulting in a statistically significant between-group difference that did not meet the threshold for clinical importance.
Among women with mixed urinary incontinence, the addition of perioperative behavioral and pelvic floor muscle therapy to midurethral sling surgery resulted in a difference in urinary incontinence symptoms that may not be clinically important.
Mixed urinary incontinence, including both stress and urgency incontinence, has adverse effects on a woman’s quality of life. Studies evaluating treatments to simultaneously improve both components are lacking.
To determine whether combining behavioral and pelvic floor muscle therapy with midurethral sling is more effective than sling alone for improving mixed urinary incontinence symptoms.
Design, Setting, and Participants
Randomized clinical trial involving women 21 years or older with moderate or severe stress and urgency urinary incontinence symptoms for at least 3 months, and at least 1 stress and 1 urgency incontinence episode on a 3-day bladder diary. The trial was conducted across 9 sites in the United States, enrollment between October 2013 and April 2016; final follow-up October 2017.
Behavioral and pelvic floor muscle therapy (included 1 preoperative and 5 postoperative sessions through 6 months) combined with midurethral sling (n = 209) vs sling alone (n = 207).
Main Outcomes and Measures
The primary outcome was change between baseline and 12 months in mixed incontinence symptoms measured by the Urogenital Distress Inventory (UDI) long form; range, 0 to 300 points; minimal clinically important difference, 35 points, with higher scores indicating worse symptoms.
Among 480 women randomized (mean [SD] age, 54.0 years [10.7]), 464 were eligible and 416 (86.7%) had postbaseline outcome data and were included in primary analyses. The UDI score in the combined group significantly decreased from 178.0 points at baseline to 30.7 points at 12 months, adjusted mean change −128.1 points (95% CI, −146.5 to −109.8). The UDI score in the sling-only group significantly decreased from 176.8 to 34.5 points, adjusted mean change −114.7 points (95% CI, −133.3 to −96.2). The model-estimated between-group difference (−13.4 points; 95% CI, −25.9 to −1.0; P = .04) did not meet the minimal clinically important difference threshold. Related and unrelated serious adverse events occurred in 10.2% of the participants (8.7% combined and 11.8% sling only).
Conclusions and Relevance
Among women with mixed urinary incontinence, behavioral and pelvic floor muscle therapy combined with midurethral sling surgery compared with surgery alone resulted in a small statistically significant difference in urinary incontinence symptoms at 12 months that did not meet the prespecified threshold for clinical importance.
ClinicalTrials.gov Identifier: NCT01959347
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Corresponding Author: Vivian W. Sung, MD, MPH, Women and Infants Hospital of Rhode Island, Division of Urogynecology and Reconstructive Pelvic Surgery, 101 Plain St, Fifth Floor, Providence, RI 02903 (email@example.com).
Accepted for Publication: July 31, 2019.
Author Contributions: Dr Gantz and Mr Carper had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Sung, Borello-France, Newman, Richter, Lukacz, Moalli, Weidner, Smith, Dunivan, Ridgeway, Gantz.
Acquisition, analysis, or interpretation of data: Sung, Lukacz, Moalli, Weidner, Smith, Dunivan, Ridgeway, Nguyen, Mazloomdoost, Carper, Gantz.
Drafting of the manuscript: Sung, Newman, Richter, Lukacz, Moalli, Weidner, Smith, Dunivan, Ridgeway, Mazloomdoost, Carper, Gantz.
Critical revision of the manuscript for important intellectual content: Sung, Borello-France, Newman, Richter, Lukacz, Moalli, Weidner, Smith, Dunivan, Ridgeway, Nguyen, Mazloomdoost, Gantz.
Statistical analysis: Newman, Richter, Carper, Gantz.
Obtained funding: Sung, Lukacz, Moalli, Smith, Gantz.
Administrative, technical, or material support: Newman, Richter, Moalli, Dunivan, Nguyen, Gantz.
Supervision: Sung, Richter, Weidner, Smith, Dunivan, Mazloomdoost, Gantz.
Other - training of interventionists for the behavioral protocol: Borello-France.
Conflict of Interest Disclosures: Dr Sung reported receiving grants from the National Institute of Child Health and Human Development (NICHD), National Institute on Aging (NIA), and Patient-Centered Outcomes Research Institute (PCORI). Dr Borello-France reported receiving grants from the NICHD. Dr Newman reported receiving grants from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and editorial fees from Digital Science Press. Dr Richter reported receiving grants from the NICHD, PCORI through Brown University, Renovia, the National Institutes of Health (NIH) through Washington University, and the NICHD, and other support from BlueWind Medical and UpToDate. Dr Lukacz reported receiving grants from the NICHD, the NIDDK, Boston Scientific, and Cogentix/Uroplasty, personal fees from Axonics, and other support from UpToDate. Dr Moalli reported receiving grants from Boston Scientific, the NIH, the NICHD, the Department of Defense, and Caldera. Dr Weidner reported receiving grants from the NIH and other support from UroCure. Dr Smith reported receiving editorial fees for a section in Gray's Anatomy. Dr Dunivan reported receiving grants from the NIDDK, NICHD, and Viveve and travel reimbursement for work for American College of Obstetricians and Gynecologists and American Board of Obstetrics and Gynecology. Dr Ridgeway reported receiving grants from the NICHD and personal fees from Coloplast Inc and Ethicon Inc. Dr Nguyen reported receiving grants from the NIDDK, Boston Scientific, and the NICHD. Dr Mazloomdoost reported receiving grants from Boston Scientific and being an employee of the NIH. Dr Carper reporting receiving grants from the NICHD. Dr Gantz reported receiving grants from the NICHD. No other disclosures were reported.
Funding/Support: Supported by grants from the NICHD and NIH Office of Research on Women’s Health (U10 HD041261, U10 HD069013, U10 HD054214, U10 HD054215, U10 HD041267, U10 HD069025, U10 HD069010, U10 HD069006, and U01 HD069031).
Role of the Funder/Sponsor: The NIH and NICHD staff had input into the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Group Information: The NICHD Pelvic Floor Disorders Network members are Women and Infants Hospital of Rhode Island: Deborah L. Myers, MD, Charles R. Rardin, MD, B. Star Hampton, MD, Cassandra Carberry, MD, Kyle Wohlrab, MD, Nicole Korbly, MD, Ann Meers, RN, Alexandra Lynch, BA, Kathryn Rhodes, BA, Wendy Fox, PT, DPT, Leslie Choquette, MSPT, Michelle Clark, MSPT, and Melissa Nassaney, DPT; University of Alabama at Birmingham: R. Edward Varner, MD, Alicia Ballard, MD, David R. Ellington, MD, Robert L. Holley, MD, Velria Willis, BSN, Nancy Saxon, BSN, Kathy Carter, BSN, Robin Willingham, BSN Julie Burge, BS, and Ryanne Johnson, MSN, CRNP; San Diego Site (University of California San Diego and Kaiser Permanente): Charles Nager, MD, Mike Albo, MD, Marianna Alperin, MD, JoAnn Columbo, BSc; Cindy Furey, RPT; Patricia Riley, RN, Lynn Hall RNP, Christine Doan, PA, Karen VandeVegte, PT, Karl M. Luber, MD, Jasmine Tan-Kim, MD, Keisha Y. Dyer, MD, Gouri B. Diwadkar, MD, Shawn A. Menefee, MD, Linda M. Mackinnon, MPH, and Gisselle Zazueta-Damian; Kaiser Permanente Downey: Sharon Jakus-Waldman, MD, MPH, Christina Liao, MD, Nancy Flores, RA, Mary Simmons, PT, DPT, and Arty Patel, PT, DPT, CSCS; University of Pittsburgh Medical Center: Halina Zyczynski, MD, Gary Sutkin, MD, Michael Bonidie, MD, Mary Ackenbom, MD, Judy Gruss, RN, Jaqueline Noel, MS, Lindsay Baranski, MS, Lori Geraci, BA, Ellen Eline, CRNP, and Karen Mislanovich, RN; Duke University Medical Center: Cindy Amundsen, MD, Anthony Visco, MD, Nazema Siddiqui, MD, MHS; Amie Kawasaki, MD, Shantae McLean, MPH, Mary Raynor, RN, Dominique Clark, BA, Weatherly Cook, RN, Nicole Longoria, PA-C, Akira Hayes, MS, and Ingrid Harm-Ernandes, PT; University of Pennsylvania Health System: Lily Arya, MD, Heidi Harvie, MD, Uduak Andy, MD, Lorraine Flick, MS, Michelle Kinglee, AS, Mary Wang, DNP, Donna Thompson, MSN, CRNP, and Teresa Carney, RN, BSN; University of New Mexico: Rebecca Rogers, MD, Yuko Komesu, MD, Peter Jeppson, MD, Sara Cichowski, MD, Karen Taylor, BA, Cassandra Castaneda, BA, Reynette Beynon, BA, Amanda Summers, BA, Sue Lee, BS, Kathleen Hopkins, MA, Julia Middendorf, RN, BSN, Christy Miller, BS, MPT, Erin Yane, BA, MPT, and Barbara White, BS; Cleveland Clinic Foundation: Matthew Barber, MD, Marie Paraiso, MD, Megan Tarr, MD, Eric Jelovsek, MD, Cecile Unger, MD, Ly Pung, RN, Annette Graham, RN, Kathleen Dastoli, RN, Maryori Edington, AAS, Elizabeth O’Dougherty, PT, Jill Dubbs, DPT, and Megan Edgehouse, PT; and Research Triangle Institute: Dennis Wallace, PhD, Carolyn Huitema, MS, Tracy Nolen, PhD, Kevin A. Wilson, MS, Brenda Hair, AAS, Kendra Glass, Daryl Matthews, AA, Maura Bearden, BS, James W. Pickett II, BS, Yan Tang, MS, Amanda Shaffer, MS, Kristin Zaterka-Baxter, BS, Lindsay Morris, BS, Kathryn Cleffi, MPH, and Carla Bann, PhD.
PFDN Data Safety and Monitoring Board Members: Kay Dickersin, PhD, Johns Hopkins Bloomberg School of Public Health, Luohua Jiang, PhD, Texas A&M Health Science University, Missy Lavender, MBA, Women’s Health Foundation, Kate O’Dell, PhD, UMass Memorial Medical Center, Kate Ryan, National Women’s Health Network, Paul Tulikangas, MD, University of Connecticut Hartford Hospital, Lan Kong, PhD, Penn State University College of Medicine, Donna McClish, PhD, Virginia Commonwealth University, Leslie Rickey, MD, MPH, Yale New Haven Hospital, David Shade, JD, The Johns Hopkins University, and Ashok Tuteja, MD, MPH, University of Utah, Susan Yount, PhD, American College of Nurse Midwives.
Data Sharing Statement: See Supplement 4.
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