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Is there a difference in treatment failure for vaginal mesh hysteropexy vs vaginal hysterectomy with uterosacral ligament suspension in women with uterovaginal prolapse?
In this randomized clinical trial that included 175 postmenopausal women with symptomatic uterovaginal prolapse undergoing surgical intervention, vaginal mesh hysteropexy compared with vaginal hysterectomy with uterosacral ligament suspension resulted in a hazard ratio for a composite measure of treatment failure of 0.62 after 3 years. This was not statistically significant, but the CI was wide and the P value was .06.
Although vaginal mesh hysteropexy did not result in a statistically significantly better outcome compared with vaginal hysterectomy with uterosacral ligament suspension, the wide CI for the treatment effect precludes a definitive conclusion, and further research is needed to assess whether vaginal mesh hysteropexy is more effective than vaginal hysterectomy with uterosacral ligament suspension.
Vaginal hysterectomy with suture apical suspension is commonly performed for uterovaginal prolapse. Transvaginal mesh hysteropexy is an alternative option.
To compare the efficacy and adverse events of vaginal hysterectomy with suture apical suspension and transvaginal mesh hysteropexy.
Design, Setting, Participants
At 9 clinical sites in the US Pelvic Floor Disorders Network, 183 postmenopausal women with symptomatic uterovaginal prolapse were enrolled in a randomized superiority clinical trial between April 2013 and February 2015. The study was designed for primary analysis when the last randomized participant reached 3 years of follow-up in February 2018.
Ninety-three women were randomized to undergo vaginal mesh hysteropexy and 90 were randomized to undergo vaginal hysterectomy with uterosacral ligament suspension.
Main Outcomes and Measures
The primary treatment failure composite outcome (re-treatment of prolapse, prolapse beyond the hymen, or prolapse symptoms) was evaluated with survival models. Secondary outcomes included operative outcomes and adverse events, and were evaluated with longitudinal models or contingency tables as appropriate.
A total of 183 participants (mean age, 66 years) were randomized, 175 were included in the trial, and 169 (97%) completed the 3-year follow-up. The primary outcome was not significantly different among women who underwent hysteropexy vs hysterectomy through 48 months (adjusted hazard ratio, 0.62 [95% CI, 0.38-1.02]; P = .06; 36-month adjusted failure incidence, 26% vs 38%). Mean (SD) operative time was lower in the hysteropexy group vs the hysterectomy group (111.5 [39.7] min vs 156.7 [43.9] min; difference, −45.2 [95% CI, −57.7 to −32.7]; P = <.001). Adverse events in the hysteropexy vs hysterectomy groups included mesh exposure (8% vs 0%), ureteral kinking managed intraoperatively (0% vs 7%), granulation tissue after 12 weeks (1% vs 11%), and suture exposure after 12 weeks (3% vs 21%).
Conclusions and Relevance
Among women with symptomatic uterovaginal prolapse undergoing vaginal surgery, vaginal mesh hysteropexy compared with vaginal hysterectomy with uterosacral ligament suspension did not result in a significantly lower rate of the composite prolapse outcome after 3 years. However, imprecision in study results precludes a definitive conclusion, and further research is needed to assess whether vaginal mesh hysteropexy is more effective than vaginal hysterectomy with uterosacral ligament suspension.
ClinicalTrials.gov Identifier: NCT01802281
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Corresponding Author: Charles W. Nager, MD, Department of Obstetrics, Gynecology, and Reproductive Sciences, UC San Diego Health, 9300 Campus Point Dr, Ste 7433, La Jolla, CA 92037 (firstname.lastname@example.org).
Accepted for Publication: August 6, 2019.
Author Contributions: Drs Nager and Wallace 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: Nager, Visco, Richter, Rardin, Rogers, Harvie, Zyczynski, Wallace.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: Nager, Visco, Richter, Rardin, Rogers, Harvie, Zyczynski, Mazloomdoost, Grey, Wallace.
Critical revision of the manuscript for important intellectual content: Nager, Visco, Richter, Rardin, Rogers, Harvie, Zyczynski, Paraiso, Mazloomdoost, Sridhar, Wallace.
Statistical analysis: Nager, Grey, Sridhar, Wallace.
Obtained funding: Visco, Richter, Rogers, Harvie, Wallace.
Administrative, technical, or material support: Nager, Visco, Rogers, Harvie, Paraiso, Mazloomdoost.
Supervision: Nager, Visco, Richter, Rardin, Harvie.
Conflict of Interest Disclosures: All of the authors reported funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institutes of Health Office of Research on Women’s Health and that Boston Scientific Corporation provided partial study support through an unrestricted grant to the data coordinating center. Dr Visco reported stock ownership in NinoMed. Dr Rardin reported grants from Pelvalon, Inc, Colace Therapeutics, and the Foundation for Female Health Awareness outside the submitted work. Dr Rogers reported receiving personal fees from the International Urogynecologic Association as the editor in chief for the International Urogynecology Journal, the American Board of Obstetrics and Gynecology as a member of the subspecialty board for the Female Pelvic Medicine and Reconstructive Surgery, and the American College of Obstetrics and Gynecology for teaching at the annual meeting, and royalties for writing for UpToDate on chapters describing the epidemiology of prolapse, its diagnosis and evaluation, as well as a chapter on the sexual function of women with pelvic floor disorders. Dr Paraiso reported receiving grants from Colopast and Caldera outside the submitted work. No other disclosures were reported.
Funding/Support: The study was conducted by the Eunice Kennedy Shriver National Institute of Child Health and Development–sponsored Pelvic Floor Disorders Network (grant numbers U10 HD054214, U10 HD041267, U10 HD041261, U10 HD069013, U10 HD069025, U10 HD069010, U10 HD069006, U10 HD054215, and U01 HD069031). The project was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institutes of Health Office of Research on Women’s Health. Boston Scientific Corporation provided partial study support through an unrestricted grant.
Role of the Funder/Sponsor: The funders had no role in 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: Emily S. Lukacz, Michael E. Albo, Marianna Alperin, Anna C. Kirby, Kimberly Ferrante, Erika Wasenda, Joann Columbo, Erika Ruppert, Kyle Herrala, Sherella Johnson (UC San Diego Health, San Diego, CA); Shawn A. Menefee, Jasmine Tan-Kim, Gouri B. Diwadkar, Keisha Y. Dyer, Linda M. Mackinnon, Gisselle Zazueta-Damian (Kaiser Permanente–San Diego); Alison Weidner, Cindy Amundsen, Nazema Siddiqui, Amie Kawasaki, Shantae McLean, Mary Raynor, Nicole Longoria, Akira Hayes, Robin Gilliam, Acacia Harris (Duke University Medical Center, Durham, NC). R. Edward Varner, Robert L. Holley, Tracey Wilson, Alicia Ballard, David Ellington, Ryanne Johnson, Alyssa Long, Lisa Pair, Velria Willis, Alice Howell, Nancy Saxon, Kathy Carter, Robin Willingham, Jill Hyde, Sunita Patel (University of Alabama at Birmingham, Dept. OB/GYN, Birmingham, AL). Vivian W. Sung, Deborah L. Myers, Cassandra Carberry, B. Star Hampton, Kyle Wohlrab, Nicole Korbly, Ann S. Meers, Samantha Douglas, Elizabeth-Ann Viscione (Alpert Medical School of Brown University, Providence, RI). Yuko Komesu, Gena Dunivan, Peter Jeppson, Sara Cichowski, Julia Middendorf, Karen Box (University of New Mexico). Lily Arya, Uduak Andy, Ariana Smith, Lorraine Flick. Michelle Kingslee, Teresa Carney, Donna Thompson (University of Pennsylvania, Philadelphia, PA). Michael Bonidie, Jerry Lowder, Pamela Moalli, Jonathan Shepherd, Gary Sutkin, Judy Gruss, Karen Mislanovich, Kate Amodei (Magee-Womens Research Institute, University of Pittsburgh, Dept. of OB/GYN & Reproductive Sciences, Pittsburgh, PA). Ly Pung, Annette Graham, Geetha Krishnan, Kathleen Dastoli, Maryori Edington, Matthew Barber, Cecile Unger, Mark Walters, Eric Jelovsek, Beri Ridgeway (Cleveland Clinic Foundation, Cleveland, OH). Marie Gantz, Sonia Thomas, Amanda Shaffer, Tracey Grant, Kelly Koeller-Anna, Ben Carper, Emily Honeycutt, Ryan Whitworth, Tracey Davis, Katrina Burson, Kendra Glass, James Pickett (RTI International, Research Triangle Park, NC), AnnaMarie Connellly (University of North Carolina, Chapel Hill, NC). Data and Safety Monitoring Board: Kay Dickersin (chair), (Johns Hopkins Bloomberg School of Public Health), Paul Tulikangas (chair) (University of Connecticut Hartford Hospital) Leslie Rickey (Yale New Haven Hospital), Donna McClish (Virginia Commonwealth University), David Shade (The Johns Hopkins University), Ashok Tuteja (University of Utah), Lan Kong (Penn State University College of Medicine), Susan Yount (Frontier Nursing University, Lexington KY), Luohua Jiang (Texas A&M Health Science University), Missy Lavender (Women’s Health Foundation), Kate O’Dell (UMass Memorial Medical Center), Kate Ryan (National Women’s Health Network).
Data Sharing Statement: See Supplement 3.
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