NCT01886794

Hormonal Status on Blood Flow and Tissue in Pelvic Organ Prolapse

Role of Hormonal Status on Vascularization and Vaginal Tissue in Women With Pelvic Organ Prolapse

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: The University of Texas Medical Branch, Galveston · Academic / Other
• Sex: Female
• Age: 21 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Our primary aim in the current study is to determine important tissue differences, including muscle and connective tissue changes, between postmenopausal women and reproductive age women with pelvic floor dysfunction to help develop targeted and noninvasive treatments.

Detailed description

Our primary aim in the current study is to determine important tissue differences, including muscle and connective tissue changes, between postmenopausal women and reproductive age women with pelvic floor dysfunction to help develop targeted and noninvasive treatments. We will perform in vivo evaluations with colposcopy and OCT to determine epithelial thickness and overall mucosal health prior to surgery. At the time of surgery, we will obtain tissue for histologic and imaging analysis.

Conditions

• Pelvic Floor Disorders

Interventions

Type	Name	Description
DRUG	Postmenopausal, topical vaginal estrogen cream	Topical vaginal estrogen cream is commonly but not universally used to improve the health of vaginal tissue prior to surgery. This study will provide data regarding estrogen effects for post-menopausal women undergoing pelvic organ prolapse.
DRUG	Placebo Comparator: Postmenopausal, topical placebo cream	Postmenopausal participants randomized to topical vaginal placebo for about one month's use prior to scheduled surgery.

Timeline

• Start date: 2013-06-06
• Primary completion: 2023-12-11
• Completion: 2023-12-11
• First posted: 2013-06-26
• Last updated: 2025-10-29
• Results posted: 2025-10-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study