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.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
5U10HD054214-07
Application #
8313627
Study Section
Special Emphasis Panel (ZHD1-DSR-N (02))
Program Officer
Parrott, Estella C
Project Start
2006-09-11
Project End
2016-06-30
Budget Start
2012-07-01
Budget End
2013-06-30
Support Year
7
Fiscal Year
2012
Total Cost
$326,757
Indirect Cost
$56,914
Name
University of California San Diego
Department
Obstetrics & Gynecology
Type
Schools of Medicine
DUNS #
804355790
City
La Jolla
State
CA
Country
United States
Zip Code
92093
Nager, Charles W; Zyczynski, Halina; Rogers, Rebecca G et al. (2016) The Design of a Randomized Trial of Vaginal Surgery for Uterovaginal Prolapse: Vaginal Hysterectomy With Native Tissue Vault Suspension Versus Mesh Hysteropexy Suspension (The Study of Uterine Prolapse Procedures Randomized Trial). Female Pelvic Med Reconstr Surg 22:182-9
Sung, Vivian W; Borello-France, Diane; Dunivan, Gena et al. (2016) Methods for a multicenter randomized trial for mixed urinary incontinence: rationale and patient-centeredness of the ESTEEM trial. Int Urogynecol J 27:1479-90
Amundsen, Cindy L; Richter, Holly E; Menefee, Shawn A et al. (2016) OnabotulinumtoxinA vs Sacral Neuromodulation on Refractory Urgency Urinary Incontinence in Women: A Randomized Clinical Trial. JAMA 316:1366-1374
Visco, Anthony G; Zyczynski, Halina; Brubaker, Linda et al. (2016) Cost-Effectiveness Analysis of Anticholinergics Versus Botox for Urgency Urinary Incontinence: Results From the Anticholinergic Versus Botox Comparison Randomized Trial. Female Pelvic Med Reconstr Surg 22:311-6
Komesu, Yuko M; Richter, Holly E; Dinwiddie, Darrell L et al. (2016) Methodology for a vaginal and urinary microbiome study in women with mixed urinary incontinence. Int Urogynecol J :
Visco, Anthony G; Brubaker, Linda; Jelovsek, J Eric et al. (2016) Adherence to Oral Therapy for Urgency Urinary Incontinence: Results from the Anticholinergic Versus Botox Comparison (ABC) Trial. Female Pelvic Med Reconstr Surg 22:24-8
Lukacz, Emily S; Warren, Lauren Klein; Richter, Holly E et al. (2016) Quality of Life and Sexual Function 2 Years After Vaginal Surgery for Prolapse. Obstet Gynecol 127:1071-9
Pearce, Meghan M; Zilliox, Michael J; Rosenfeld, Amy B et al. (2015) The female urinary microbiome in urgency urinary incontinence. Am J Obstet Gynecol 213:347.e1-11
Richter, Holly E; Whitehead, Nedra; Arya, Lily et al. (2015) Genetic contributions to urgency urinary incontinence in women. J Urol 193:2020-7
Richter, Holly E; Nager, Charles W; Burgio, Kathryn L et al. (2015) Incidence and Predictors of Anal Incontinence After Obstetric Anal Sphincter Injury in Primiparous Women. Female Pelvic Med Reconstr Surg 21:182-9

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