Pelvic floor disorders are common, bothersome, and inadequately treated. The overarching aim of the investigators from the proposed University of Utah Pelvic Floor Disorders Network Clinical Site is to improve women's health in the area of pelvic floor dysfunction. To this end, site specific aims include: 1) Identifying priority areas of research, 2) Developing assessment tools, 3) Developing and implementing PFDN protocols 4) Recruiting and enrolling subjects in PFDN protocols, 5) Achieving on-target recruitment goals and high subject retention 6) Ensuring high-quality data 7) Transmitting data accurately to the Data Coordinating Center, 8) Participating in data analysis, 9) Disseminating results to the research community, and 10) Producing high-quality publications The broad scientific aim for the randomized clinical trial outlined in this proposal is to evaluate whether a pessary placed immediately after vaginal surgery for pelvic organ prolapse improves anatomic success compared to usual care.

Public Health Relevance

One in four American women has moderate to severe symptoms of pelvic floor disorders. Improving prevention, diagnosis and treatment of these disorders is crucial. The University of Utah has contributed substantially to our knowledge in this area and has demonstrated its ability to fully participate in the cooperative mechanism of the Pelvic Floor Disorders Network. Through continued participation in this network, the multi-disciplinary team of Utah site investigators plan to progress women's healthcare further.

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 #
5U10HD054136-07
Application #
8305420
Study Section
Special Emphasis Panel (ZHD1-DSR-N (02))
Program Officer
Parrott, Estella C
Project Start
2006-09-01
Project End
2016-06-30
Budget Start
2012-07-01
Budget End
2013-06-30
Support Year
7
Fiscal Year
2012
Total Cost
$14,726
Indirect Cost
$4,876
Name
University of Utah
Department
Obstetrics & Gynecology
Type
Schools of Medicine
DUNS #
009095365
City
Salt Lake City
State
UT
Country
United States
Zip Code
84112
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
Brubaker, Linda; Nager, Charles W; Richter, Holly E et al. (2014) Urinary bacteria in adult women with urgency urinary incontinence. Int Urogynecol J 25:1179-84
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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