The University of Alabama at Birmingham (UAB) is seeking to successfully compete in the third cycle of the NICHD sponsored Pelvic Floor Disorders Network. As a part of this important research infrastructure we have demonstrated our credible, productive, multidisciplinary clinical approach to the evaluation and treatment of women with pelvic floor disorders including urinary and fecal incontinence as well as pelvic organ prolapse. We have substantially contributed to the Network activities by participating at all levels of clinical trial design, implementation, recruitment, intervention implementation, retention and scientific reporting. We have reported outcomes and implication for care of these research initiatives at national and international scientific meetings and we are committed to continuing these activities. Through this application with its concept proposal, we wish to highlight our ability and commitment to continue these meaningful research activities. Current common treatment options for fecal incontinence (Fl) include behavioral therapy consisting of pelvic muscle exercises, diet and defecatory strategies and surgical approaches including anal sphincter repair, artificial bowel sphincter and as a last resort, colostomy. A significant proportion of women with Fl, however, do not gain benefit from behavioral therapy or sphincter repair yet do not wish to undergo colostomy. As the population of post-reproductive women continues to increase, it is imperative to study other treatment options that improve quality of life for this condition. An existing modality called sacral neuromodulation (SNM, Interstim(R)) has been FDA approved and utilized for the treatment of refractory urge incontinence. Two small randomized trials and several cohort studies have shown efficacy of sacral neuromodulation for the treatment of refractory Fl (although it is not yet FDA approved for this indication). We propose a randomized trial to credibly characterize the effect of SNM on Fl episodes, symptom specific quality of life, effect on other pelvic floor symptoms, sexual function, predictors of response, adverse events, cost effectiveness and the role of biomarkers in optimal and suboptimal responses to this treatment. This information will allow us to more effectively individualize treatment for women with this condition.

Public Health Relevance

In order to improve on the care and individualized treatment for women with pelvic floor disorders, it is important that a credible research program exists that helps guide provider care. The Pelvic Floor Disorders Network (NICHD) performs such research and we are competing to continue to participate in this important initiative. As a part of this application, we propose a concept describing a randomized trial of sacral neuromodulation for the treatment of women with fecal incontinence refractory to current standard of care treatments. This exciting new treatment modality may help a cohort of women with diminished quality of life.

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 #
5U10HD041261-12
Application #
8311566
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
$314,940
Indirect Cost
$99,964
Name
University of Alabama Birmingham
Department
Obstetrics & Gynecology
Type
Schools of Medicine
DUNS #
063690705
City
Birmingham
State
AL
Country
United States
Zip Code
35294
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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
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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
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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
Richter, Holly E; Whitehead, Nedra; Arya, Lily et al. (2015) Genetic contributions to urgency urinary incontinence in women. J Urol 193:2020-7
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

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