Effect of Preoperative Estrogen Treatment on Connective Tissues of the Pelvic Floor
Status:
Completed
Trial end date:
2013-04-01
Target enrollment:
Participant gender:
Summary
This is a study to determine how vaginal estrogen cream given for several weeks before pelvic
reconstructive therapy will effect elastic fiber assembly in the muscularis layer of the
vaginal wall. Postmenopausal women with at least Stage 2 pelvic organ prolapse will receive
either estrogen vaginal cream or placebo cream 6-8 weeks prior to reconstructive surgery. At
time of surgery, full thickness biopsies will be obtained from a standardized location at the
top of vagina. The investigators will measure the thickness of the vaginal muscularis,
elastic fiber number and morphology, and analyze if elastic fiber synthesis or degradation is
affected by estrogen therapy. The results will provide important data to support a larger
clinical trial to determine if preoperative and maintenance estrogen therapy alter long-term
success rates of pelvic reconstructive surgery for pelvic organ prolapse.
Phase:
Phase 4
Details
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborator:
American Urogynecologic Society Foundation Astellas Research Award