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The UCSD Women's Pelvic Medicine Research group is a standing member of several NIH sponsored research consortiums including PFDN; Pelvic Floor Disorders network and PLUS; Prevention of Lower Urinary Tract Symptoms. The group also participates in industry sponsored studies and smaller clinical trials. Currently the group is participating in 6 active research protocols and maintaining records and compliance documents for approximately 10 open studies. The group anticipates continued grant support from federal and industry sources with new protocols under development and review.
The Pelvic Floor Disorders Network (PFDN) conducts a variety of clinical trials (medical, surgical and therapeutic) focused on treatment of women with pelvic floor disorders such as fecal/urinary incontinence and pelvic organ prolapse. The PFDN is a national research collaboration between seven universities and medical institutions around the nation. UCSD WPMC-R is currently conducting longitudinal follow up research protocol activities on approximately 40 active patients. The UCSD site is one of three San Diego based clinical trial sites along with Kaiser Permanente San Diego and Downey. Coordination and communication with investigators and research personnel at these site has been established for nearly 20 years.
The main follow up research activities center around randomized trials that conduct observational evaluations on women that undergo pelvic organ prolapse surgical repair and a randomized trial of botox vs. sling surgery for mixed urinary incontinence.
Additional PFDN protocols in startup phase will focus on surgical specimen collection, processing and shipment to a centralized biomed laboratory.
The Prevention of Lower Urinary Symptoms (PLUS) network is a trans-disciplinary group of investigators developing a research agenda for the prevention of lower urinary symptoms (LUTS) across the nation. The PLUS consortium is currently focused on instrument validation and qualitative research in the area of bladder health and prevention of LUTS. Protocol development is underway for a large scale, multi-centered, longitudinal cohort with in person assessments, specimen collections and survey follow up over a 5+ year period. The UCSD site is tasked with recruiting and enrolling bilingual Spanish/English speaking participants for our studies.
Recurrent Urinary Tract Infection and linking the host genome to the urinary microbiota clinical research study. This research study aims to find out more about recurrent urinary tract infection how it relates to the urinary microbiome and how to collect urine in order to better study its relationship.
Other industry sponsored clinical trials that are closing soon include observational longitudinal studies of women undergoing prolapse and incontinence surgeries.
When necessary, our unit provides research support to other principal investigators within the Obstetrics, Gynecology & Reproductive Sciences Department time and resources permitting.
Reports directly to the PI of Women's Pelvic Medicine Research. Assist with coordination and management of clinical trials including supporting all aspects of protocol research protocol development/management, including screening for patient eligibility, data collection (including non invasive physical examination procedures e.g. vital signs, bladder scanning) and analysis, ensuring protocol compliance, adverse event reports, monitoring treatment and toxicities, laboratory and specimen (e.g. urine, blood, stool, vaginal swabs, etc) collection, processing and submission, and maintenance of accurate and complete clinical research records.
Assist PI and Research Compliance Analyst with pre-screening patients for eligibility, maintaining screening and enrollment tables, review of lab result and lab data and help identify abnormal results. Assist with writing proposals, progress reports and manuscripts. Help development and distribution of recruitment materials. Assist the regulatory department with Human subject research submissions, renewals, and safety reports. Directly communicate with assigned physicians and research groups within and outside UCSD, including attending weekly meetings as Ast. Clinical Research Coordinator member within the PFDN and PLUS networks and local meetings with PIs. Provide direct assistance to the Research Compliance Analyst in reviewing and verifying university research account statements, professional fee statements, and invoicing.
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