Effect of Preoperative Estrogen Treatment on Connective Tissues of the Pelvic Floor

Study ID
STU 042011-101

Cancer Related
No

Healthy Volunteers
Yes

Study Sites

  • Parkland Health & Hospital System
  • Parkland Health & Hospital System
  • UT Southwestern Ambulatory Services
  • UT Southwestern Ambulatory Services
  • UT Southwestern University Hospital—St. Paul
  • UT Southwestern University Hospital—St. Paul

Contact
Elva Moore
214-645-3833
kelly.moore@utsouthwestern.edu

Principal Investigator
David Rahn

Summary

Estrogen treatment is commonly used by pelvic surgeons in preoperative regimens for reconstructive surgery of the pelvic floor. There is no information regarding the efficacy of this treatment on vaginal wall connective tissue and if this treatment is of any benefit before or after surgical repair of pelvic organ prolapse. Since failure rates of reconstructive surgery are high, a positive effect of estrogen on the vaginal wall may lead to increased success rates. We plan to conduct a randomized controlled clinical trial to prospectively analyze the effect of preoperative vaginal estrogen treatment on elastic fiber synthesis and degradation in the vaginal wall. 30 postmenopausal women with pelvic organ prolapse undergoing surgical repair will be randomized to two treatment regimens: (i) 6-8 weeks of preoperative vaginal cream, or (ii) 6-8 weeks of preoperative placebo cream. Vaginal wall biopsies will be obtained at the time of surgery for analysis.

Participant Eligibility

 Symptomatic apical vaginal prolapse greater than or equal to Stage 2 (i.e., apical bulge extends to at least 1 cm of the hymen or beyond)
 Women between 1 and 10 years after menopause. Menopause is defined as one year of amenorrhea or surgical ovariectomy.
 Age 40-70 years old
 Planned surgical repair for pelvic organ prolapse
 No estrogen replacement therapy in the last 1 month
 Physically capable of daily application of vaginal cream