The mission of the PFDN is to identify optimal diagnosis and management strategies for women with pelvic floor disorders (PFDs) and this is directly in line with Women and Infants Hospital (WIH)/Brown's mission and commitment. WIH is a women's hospital, focused solely on advancing women's health and research and our extremely high volume, stable patient base, expertise of our multi-disciplinary collaborative and established research infrastructure provide the ideal environment to conduct large-scale, clinical research at the highest level.
The aim of this application is for WIH/Brown to become the first PFDN site in New England by demonstrating: 1)our academic productivity and experience in multi-site, collaborative surgical, pharmaceutical and non-surgical clinical trials;2)highly committed investigators with expertise in research methods and a specialized research team qualified to conduct multiple protocols, manage high quality data, and maintain high recruitment and retention;3)a long-standing, formal relationship with multi-disciplinary collaborators committed to advancing the care of women with PFDs led by Urogynecology (including Urology, Colorectal surgery, Women's Gastroenterology, Women's Physical Therapy, and Women's Radiology);and 4)our high clinical volume (In 2009, the Division of Urogynecology evaluated 1211 new patients and performed 583 PFD surgical procedures;vaginal, abdominal, laparoscopic and robotic approaches are all represented). We present a concept proposal describing a 3-stage, randomized trial of a combined non-surgical and surgical approach to treatment of mixed urinary incontinence (MUl) in women who have failed conservative therapy and/or elect surgical treatment. Women suffering from MUl are at high risk for failure of segregated treatments and are often excluded from clinical trials focused on either stress or urge urinary incontinence alone. Clinical management of MUl remains a challenge and trials targeting this population are urgently needed. WIH has a long-standing history of supporting network collaboratives and our goal is to participate and become a leader in the PFDN in terms of protocol development and completion, data interpretation and quality, recruitment and retention and high quality dissemination of findings.

Public Health Relevance

Female pelvic floor disorders including urinary incontinence, pelvic organ prolapse and fecal incontinence are common, disabling conditions and are a significant public health issue. Although a variety of treatment options exist, high quality evidence to guide clinical management and to improve treatment specificity is still needed. Through the PFDN, WIH/Brown is committed to advancing high quality scientific evidence to help improve the care of women and reduce the burden of these 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 #
5U10HD069013-03
Application #
8495377
Study Section
Special Emphasis Panel (ZHD1-DSR-N (02))
Program Officer
Parrott, Estella C
Project Start
2011-08-16
Project End
2016-06-30
Budget Start
2013-07-01
Budget End
2014-06-30
Support Year
3
Fiscal Year
2013
Total Cost
$318,438
Indirect Cost
$99,580
Name
Women and Infants Hospital-Rhode Island
Department
Type
DUNS #
069851913
City
Providence
State
RI
Country
United States
Zip Code
02905
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
Sung, Vivian W; Rogers, Rebecca G; Bann, Carla M et al. (2014) Symptom outcomes important to women with anal incontinence: a conceptual framework. Obstet Gynecol 123:1023-30