This application proposes work that advances the clinical and translational science of female pelvic floor disorders by continuing collaboration within the Pelvic Floor Disorders Network. The over-arching objective of this application is to contribute the skills and talents of Loyola investigators to on-going studies as well as the design, conduct and dissemination of studies in various stages of planning. Prior PFDN work has highlighted the striking prevalence of female pelvic floor disorders. This application describes the Loyola investigators (including past and on-going contributions), the potential participant population (including clinical volume numbers), facilities (including clinical and translational capabilities) and a concept for a proposed clinical study with concomitant translational aims. The proposal also describes our prior contributions as evidence of continuing success for the next funding cycle. Mixed urinary incontinence (MUI) is the area of research focus in the brief concept for the research proposal. Specifically, the concept proposes the broad skeleton design for a randomized clinical trial with 2-year follow-up to study women with MUI who plan surgery for treatment of stress urinary incontinence.
Three specific aims are planned for the concept. The clinical aim is to determine the utility of peri-operative urge urinary incontinence therapy on peri-operative urinary incontinence symptoms and urinary incontinence-related bother over two years.
The second aim i s translational and will continue PFDN work on describing the peri-operative urinary microbiome. In addition, the investigators will assess recruitment and retention issues for such a study. This work will scientifically complement the PFDN's established line of investigation which has been started as a supplementary study to the ABC (Anticholinergic and Botulinum Comparison) trial.

Public Health Relevance

American women are affected by pelvic floor disorders, including urinary incontinence, pelvic organ prolapse and fecal incontinence, yet there is insufficient clinical and translational science to provide effective, durable treatment. The etiology and pathophysiology of these common conditions are grossly understudied. Resources are required to seek clinical and translational advances in female pelvic floor disorders.

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 #
5U10HD041250-14
Application #
8699791
Study Section
Special Emphasis Panel (ZHD1-DSR-N (02))
Program Officer
Parrott, Estella C
Project Start
2001-09-01
Project End
2016-06-30
Budget Start
2014-07-01
Budget End
2015-06-30
Support Year
14
Fiscal Year
2014
Total Cost
$14,313
Indirect Cost
$4,739
Name
Loyola University Chicago
Department
Obstetrics & Gynecology
Type
Schools of Medicine
DUNS #
791277940
City
Maywood
State
IL
Country
United States
Zip Code
60153
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
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
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
Markland, Alayne; Wang, Lu; Jelovsek, J Eric et al. (2015) Symptom improvement in women after fecal incontinence treatments: a multicenter cohort study of the pelvic floor disorders network. Female Pelvic Med Reconstr Surg 21:46-52
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
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
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

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