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.

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 #
5U10HD041250-10
Application #
7877885
Study Section
Special Emphasis Panel (ZHD1-DSR-A (19))
Program Officer
Woo, Jason
Project Start
2001-09-01
Project End
2011-06-30
Budget Start
2010-07-01
Budget End
2011-06-30
Support Year
10
Fiscal Year
2010
Total Cost
$253,192
Indirect Cost
Name
Loyola University Chicago
Department
Obstetrics & Gynecology
Type
Schools of Medicine
DUNS #
791277940
City
Maywood
State
IL
Country
United States
Zip Code
60153
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
Mueller, Elizabeth R; Wolfe, Alan J; Brubaker, Linda (2017) Female urinary microbiota. Curr Opin Urol 27:282-286
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
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
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
Brubaker, Linda; Wolfe, Alan (2016) The urinary microbiota: a paradigm shift for bladder disorders? Curr Opin Obstet Gynecol 28:407-12
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

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