The objectives and aims of this application are for the San Diego site to continue its work In the Pelvic Floor Disorders Network (PFDN). The unique strength of our application is our proven two site model, which combines the strengths of 7 academic investigators at both a tertiary medical center and a large volume HMO. We would like to provide leadership, continuity, innovation, academic expertise, a captured diverse patient population, and a proven research infrastructure to the network. We have a track-record of being the top 2 recruitment in surgical trials for pelvic floor disorders and we want to continue that into the third cycle of the PFDN. As noted in the RFA,"""""""" In many cases, clinicians caring for women with pelvic floor disorders have adopted principles of care and surgical techniques before rigorous, objective, controlled evaluation has taken place. New devices and techniques have had a dramatic influence on surgical practice..."""""""".Our study addresses this concern. Vaginal mesh is probably the most controversial topic in pelvic floor disorders and a strong argument can be made that the PFDN is the best group to study it. A growing-trend of women is seeking uterine sparing surgery for prolapse and a growing trend of gynecologists and urologists are managing uterine prolapse with vaginal mesh kit procedures. Our proposed randomized trial of uterine sparing, grafted vaginal apical suspension vs. traditional hysterectomy with native tissue suspension addresses the very important question of whether it is necessary to remove the uterus to treat uterine prolapse. This proposed study recognizes the role of new devices and techniques that are changing our care of women with pelvic floor disorders. Our comprehensive outcome measures should allow us to answer whether these new uterine-sparing, apical vaginal procedures are reasonable alternatives to conventional vaginal hysterectomy and native tissue suspension.

Public Health Relevance

Our site's participation in the next cycle of the PFDN should allow successful network recruitment for surgical trials. Uterine prolapse is a very common pelvic floor disorder and we should determine the best vaginal surgical treatment for this condition. This proposed research study will answer whether uterine - sparing procedures are reasonable alternatives to hysterectomy for this condition.

National Institute of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
Application #
Study Section
Special Emphasis Panel (ZHD1-DSR-N (02))
Program Officer
Parrott, Estella C
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University of California San Diego
Obstetrics & Gynecology
Schools of Medicine
La Jolla
United States
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Jelovsek, J Eric; Chagin, Kevin; Lukacz, Emily S et al. (2018) Models for Predicting Recurrence, Complications, and Health Status in Women After Pelvic Organ Prolapse Surgery. Obstet Gynecol 132:298-309
Arya, Lily A; Richter, Holly E; Jelovsek, Eric et al. (2018) Metabolites and microbial composition of stool of women with fecal incontinence: Study design and methods. Neurourol Urodyn 37:634-641
Jelovsek, J Eric; Barber, Matthew D; Brubaker, Linda et al. (2018) Effect of Uterosacral Ligament Suspension vs Sacrospinous Ligament Fixation With or Without Perioperative Behavioral Therapy for Pelvic Organ Vaginal Prolapse on Surgical Outcomes and Prolapse Symptoms at 5 Years in the OPTIMAL Randomized Clinical Trial. JAMA 319:1554-1565
Rogers, Rebecca G; Nolen, Tracy L; Weidner, Alison C et al. (2018) Surgical Outcomes After Apical Repair for Vault Compared With Uterovaginal Prolapse. Obstet Gynecol 131:475-483
Newman, Diane K; Borello-France, Diane; Sung, Vivian W (2018) Structured behavioral treatment research protocol for women with mixed urinary incontinence and overactive bladder symptoms. Neurourol Urodyn 37:14-26
Rogers, Rebecca G; Nolen, Tracy L; Weidner, Alison C et al. (2018) Open sacrocolpopexy and vaginal apical repair: retrospective comparison of success and serious complications. Int Urogynecol J 29:1101-1110
Amundsen, Cindy L; Komesu, Yuko M; Chermansky, Christopher et al. (2018) Two-Year Outcomes of Sacral Neuromodulation Versus OnabotulinumtoxinA for Refractory Urgency Urinary Incontinence: A Randomized Trial. Eur Urol 74:66-73
Markland, Alayne D; Jelovsek, J Eric; Rahn, David D et al. (2017) Irritable Bowel Syndrome and Quality of Life in Women With Fecal Incontinence. Female Pelvic Med Reconstr Surg 23:179-183
Komesu, Yuko M; Richter, Holly E; Dinwiddie, Darrell L et al. (2017) Methodology for a vaginal and urinary microbiome study in women with mixed urinary incontinence. Int Urogynecol J 28:711-720
Wei, John T; Dunn, Rodney; Nygaard, Ingrid et al. (2017) Development and Validation of a Quantitative Measure of Adaptive Behaviors in Women With Pelvic Floor Disorders. Female Pelvic Med Reconstr Surg 23:232-237

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