The objective of this application is to highlight the San Diego Pelvic Floor Consortium (SDPFC) site qualifications to continue in the next cycle of the Pelvic Floor Disorders Network (PFDN). The success of the SDPFC in the PFDN has largely been due to our proven two-site model, which combines the strength of a tertiary academic medical center (University of California San Diego ? UCSD) and a large volume community based health maintenance organization (Kaiser Permanente San Diego ? Kaiser). Our site has contributed meaningfully over the past two cycles by designing and selecting cutting edge clinical trials ideally suited to this multi-centered, multi-disciplinary research network. We intend to continue to foster novel research ideas and work collaboratively with the other clinical sites and the data-coordinating center to refine studies ideally suited to clinical trials requiring large-scales and diverse populations. We boast a history of successful concept development, experience in survey development and refinement, successful implementation and recruitment for large-scale clinical trials, extensive experience in implementation of randomized trials of behavioral and surgical interventions, and maintaining high retention rates and quality data. The 12 members of the SDPFC are a diverse group of urogynecologists and urologists with the depth and breadth of scientific and clinical expertise necessary for the PFDN to continue advancing the field of Female Pelvic Medicine & Reconstructive Surgery. Additionally, our site has a well-established research institution, funded by the NIH sponsored Clinical & Translational Science Award, with the full spectrum of resources and personnel available to conduct basic science, translational, epidemiologic, behavioral, and clinical research across a diverse racial/ethnic community. Our team has a strong history of collaboration in multicenter research and extensive track record in successful recruitment for the full spectrum of research possibilities for this network. The SDPFC is poised to continue to recruit subjects into existing and upcoming trials at the highest levels. We feel that the intellectual contributions, leadership experience, diversity and experience in collaborative research projects makes the SDPFC ideal for this network.

Public Health Relevance

Pelvic Floor Disorders (PFD) negatively impact millions of women and are major a source of personal and economic burden. Identification of safe and cost-effective treatment strategies for PFD often requires large-scale, multi-centered, randomized trials to quickly and accurately assess outcomes in a diverse population. The investigators in the San Diego Pelvic Floor Consortium, in collaboration with the other sites and data coordinating center, are poised to remain leaders in development of innovative research ideas, maintenance of high levels of recruitment and retention of subjects in clinical trials, and presentation of results in prestigious venues.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Clinical Research Cooperative Agreements - Single Project (UG1)
Project #
5UG1HD054214-14
Application #
9747102
Study Section
Special Emphasis Panel (ZHD1)
Program Officer
Halvorson, Lisa M
Project Start
2006-09-11
Project End
2021-06-30
Budget Start
2019-07-01
Budget End
2020-06-30
Support Year
14
Fiscal Year
2019
Total Cost
Indirect Cost
Name
University of California, San Diego
Department
Obstetrics & Gynecology
Type
Schools of Medicine
DUNS #
804355790
City
La Jolla
State
CA
Country
United States
Zip Code
92093
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
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
Wei, John T; Dunn, Rodney; Nygaard, Ingrid et al. (2017) Development and Validation of a Quantitative Measure of Adaptive Behaviors in Women With Pelvic Floor Disorders. Female Pelvic Med Reconstr Surg 23:232-237
Nager, Charles W; Zyczynski, Halina; Rogers, Rebecca G et al. (2016) The Design of a Randomized Trial of Vaginal Surgery for Uterovaginal Prolapse: Vaginal Hysterectomy With Native Tissue Vault Suspension Versus Mesh Hysteropexy Suspension (The Study of Uterine Prolapse Procedures Randomized Trial). Female Pelvic Med Reconstr Surg 22:182-9
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
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
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
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
Brubaker, Linda; Nager, Charles W; Richter, Holly E et al. (2014) Effectiveness of blinding: sham suprapubic incisions in a randomized trial of retropubic midurethral sling in women undergoing vaginal prolapse surgery. Am J Obstet Gynecol 211:554.e1-7

Showing the most recent 10 out of 12 publications