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 #
5U10HD041250-13
Application #
8495363
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
2013-07-01
Budget End
2014-06-30
Support Year
13
Fiscal Year
2013
Total Cost
$13,021
Indirect Cost
$4,311
Name
Loyola University Chicago
Department
Obstetrics & Gynecology
Type
Schools of Medicine
DUNS #
791277940
City
Maywood
State
IL
Country
United States
Zip Code
60153
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
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
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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