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.
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.
|Jelovsek, J Eric; Chagin, Kevin; Brubaker, Linda et al. (2014) A model for predicting the risk of de novo stress urinary incontinence in women undergoing pelvic organ prolapse surgery. Obstet Gynecol 123:279-87|
|Jelovsek, John Eric; Chen, Zhen; Markland, Alayne D et al. (2014) Minimum important differences for scales assessing symptom severity and quality of life in patients with fecal incontinence. Female Pelvic Med Reconstr Surg 20:342-8|
|Moalli, Pamela; Brown, Bryan; Reitman, Maureen T F et al. (2014) Polypropylene mesh: evidence for lack of carcinogenicity. Int Urogynecol J 25:573-6|
|Grimes, Cara L; Lukacz, Emily S; Gantz, Marie G et al. (2014) What happens to the posterior compartment and bowel symptoms after sacrocolpopexy? evaluation of 5-year outcomes from E-CARE. Female Pelvic Med Reconstr Surg 20:261-6|
|Sung, Vivian W; Rogers, Rebecca G; Bann, Carla M et al. (2014) Symptom outcomes important to women with anal incontinence: a conceptual framework. Obstet Gynecol 123:1023-30|
|Barber, Matthew D; Brubaker, Linda; Burgio, Kathryn L et al. (2014) Comparison of 2 transvaginal surgical approaches and perioperative behavioral therapy for apical vaginal prolapse: the OPTIMAL randomized trial. JAMA 311:1023-34|
|Amundsen, Cindy L; Richter, Holly E; Menefee, Shawn et al. (2014) The Refractory Overactive Bladder: Sacral NEuromodulation vs. BoTulinum Toxin Assessment: ROSETTA trial. Contemp Clin Trials 37:272-83|
|Gutman, Robert E; Nygaard, Ingrid E; Ye, Wen et al. (2013) The pelvic floor complication scale: a new instrument for reconstructive pelvic surgery. Am J Obstet Gynecol 208:81.e1-9|
|Nygaard, Ingrid; Brubaker, Linda; Zyczynski, Halina M et al. (2013) Long-term outcomes following abdominal sacrocolpopexy for pelvic organ prolapse. JAMA 309:2016-24|
|Brubaker, Linda; Richter, Holly E; Barber, Matthew D et al. (2013) Pelvic floor disorders clinical trials: participant recruitment and retention. Int Urogynecol J 24:73-9|
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