Loyola is a productive, innovative clinical research institution that has contributed to the first cycle of the Pelvic Floor Disorders Network and we are eager to build on the PFDN's excellent start. Our application documents: I. The Qualifications and Commitment of Institution and Key Personnel at Loyola A qualified and committed institution with a multidisciplinary faculty with experience in clinical trials design and conduct. A highly qualified and committed research team Lead by the same PI, Dr. Brubaker, this research team contains urogynecologists and urologists. Two of the faculty members received Master's Degrees in Clinical Research Design and Statistical Analysis and one is currently in this degree program. A cadre of study coordinators are cross-trained to meet the needs of the PFDN study roster. The team has a excellent collaborations within the Loyola faculty. II. Loyola's Participation in PFDN Protocols and Procedures High quality participation in PFDN protocols with excellent and consistent recruitment. We also demonstrate our consistent contributions in PFDN work, including dissemination of PFDN scientific findings. Loyola has been productive and has worked well with the PFDN team. Our first cycle application proposed the essence of the CARE trial, which was completed ahead of schedule and is under consideration for publication. III. A Feasible, Scientifically Relevant Concept Protocol (Randomized Surgical Trial): We believe we have demonstrated our ability to design and conduct high quality clinical trials. This application also describes a randomized surgical trial for women who select vaginal apical reconstruction. A comparison of the two most common techniques may inform a future study which seeks to determine which route of surgery (abdominal vs. vaginal) is best suited for an individual woman. This trial is a feasible, scientifically relevant randomized surgical trial. The draft protocol is suitable for PFDN Steering Committee discussion and revision, prior to implementation.

National Institute of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Cooperative Clinical Research--Cooperative Agreements (U10)
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Special Emphasis Panel (ZHD1-DSR-A (19))
Program Officer
Woo, Jason
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Loyola University Chicago
Obstetrics & Gynecology
Schools of Medicine
United States
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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
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
Brubaker, Linda; Wolfe, Alan J (2017) The female urinary microbiota, urinary health and common urinary disorders. Ann Transl Med 5:34
Brubaker, Linda; Wolfe, Alan J (2017) The Female Urinary Microbiota/Microbiome: Clinical and Research Implications. Rambam Maimonides Med J 8:
Brubaker, Linda; Wolfe, Alan J (2017) Microbiota in 2016: Associating infection and incontinence with the female urinary microbiota. Nat Rev Urol 14:72-74

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