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 #
5U10HD041250-12
Application #
8308278
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
2012-07-01
Budget End
2013-06-30
Support Year
12
Fiscal Year
2012
Total Cost
$13,548
Indirect Cost
$4,486
Name
Loyola University Chicago
Department
Obstetrics & Gynecology
Type
Schools of Medicine
DUNS #
791277940
City
Maywood
State
IL
Country
United States
Zip Code
60153
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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
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
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
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
Kenton, Kimberly; Barber, Matthew; Wang, Lu et al. (2012) Pelvic floor symptoms improve similarly after pessary and behavioral treatment for stress incontinence. Female Pelvic Med Reconstr Surg 18:118-21
Visco, Anthony G; Brubaker, Linda; Richter, Holly E et al. (2012) Anticholinergic versus botulinum toxin A comparison trial for the treatment of bothersome urge urinary incontinence: ABC trial. Contemp Clin Trials 33:184-96

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