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.
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.
|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|
|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|
|Markland, Alayne D; Jelovsek, J Eric; Rahn, David D et al. (2017) Irritable Bowel Syndrome and Quality of Life in Women With Fecal Incontinence. Female Pelvic Med Reconstr Surg 23:179-183|
|Komesu, Yuko M; Richter, Holly E; Dinwiddie, Darrell L et al. (2017) Methodology for a vaginal and urinary microbiome study in women with mixed urinary incontinence. Int Urogynecol J 28:711-720|
|Richter, Holly E; Moalli, Pamela; Amundsen, Cindy L et al. (2017) Urinary Biomarkers in Women with Refractory Urgency Urinary Incontinence Randomized to Sacral Neuromodulation versus OnabotulinumtoxinA Compared to Controls. J Urol 197:1487-1495|
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