The Loyola team plans to participate in the Clinical Trials Network in order to advance its understanding of the clinical care of women with pelvic floor disorders. The multi-disciplinary team has the volume and proven ability to participate in clinical trials. As requested in the RFA, a concept protocol is offered that studies clinically relevant aspects of the urinary continence mechanism in women with advanced pelvic organ prolapse. Specifically, the applicant proposes to compare routine versus selective urethropexy at the time of sacrocolpopexy in women with advanced pelvic organ prolapse (POP). This protocol will complement the ongoing, NIDDK trial which randomized genuine stress incontinence (GSI) patients to the Burch urethropexy versus the pubovaginal sling. Women with advanced POP are excluded from that trial, yet constitute a large number of affected patients. The applicant seeks to determine the efficacy and side effect rates for the Burch urethropexy in this setting. The concept protocol compares two common clinical methods of treatment in order to determine the optimal method. In addition, the applicant is planning to study the level of testing necessary to select the best protocol for the individual patient. Finally, the concept protocol will use the data from this clinical trials network to propose a standardized nomenclature to describe the status of the urinary continence status in women with advanced POP. Simply put, the concept protocol will: Determine which advanced POP patients need which urinary testing, if any; Determine the efficacy and side effects (across the whole pelvic floor) of routine versus selective Burch urethropexy; and Propose a data-based standardized nomenclature to describe the urinary continence status of women with advanced POP.

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 #
1U10HD041250-01
Application #
6401662
Study Section
Special Emphasis Panel (ZHD1-DRG-D (13))
Program Officer
Weber, Anne M
Project Start
2001-09-01
Project End
2006-06-30
Budget Start
2001-09-01
Budget End
2002-06-30
Support Year
1
Fiscal Year
2001
Total Cost
$295,423
Indirect Cost
Name
Loyola University Chicago
Department
Obstetrics & Gynecology
Type
Schools of Medicine
DUNS #
791277940
City
Maywood
State
IL
Country
United States
Zip Code
60153
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
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
Brubaker, Linda; Wolfe, Alan J (2017) The female urinary microbiota, urinary health and common urinary disorders. Ann Transl Med 5:34
Brubaker, Linda; Wolfe, Alan J (2017) The Female Urinary Microbiota/Microbiome: Clinical and Research Implications. Rambam Maimonides Med J 8:
Brubaker, Linda; Wolfe, Alan J (2017) Microbiota in 2016: Associating infection and incontinence with the female urinary microbiota. Nat Rev Urol 14:72-74

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