Hormonal Status on Blood Flow and Tissue in Pelvic Organ Prolapse

Phase 4

Terminated

• Conditions: Pelvic Floor Disorders
• Interventions: Drug: Postmenopausal, topical vaginal estrogen cream

• Registration Number: NCT01886794
• Lead Sponsor: The University of Texas Medical Branch, Galveston

Brief 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.

Study Timeline

• Study Start: 2013-06-06
• Study First Submitted: 2013-06-14
• Study First Submitted QC: 2013-06-21
• Study First Posted: 2013-06-26
• Primary Completion: 2023-12-11
• Study Completion: 2023-12-11
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-08
• Last Update Posted: 2024-03-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 10

Inclusion Criteria

• 21 to 70 years of age
• Stage II or greater pelvic organ prolapse (POP)
• Individuals electing surgery to treat their POP
• Willing and able to comply with study procedures
• Willing and able to provide written informed consent

Exclusion Criteria

• Contraindication for estrogen cream
• Any medical condition that in the opinion of the investigator would place the subject at increased risk for participation
• History of connective tissue disease
• Previous hysterectomy or pelvic organ prolapse surgery
• Known allergic reaction to any agent required by the protocol
• Use of hormone therapy in postmenopausal women in the last 90 days
• Pregnant or lactating females
• History of prior noncompliance or the presence or history of psychiatric condition that would in the opinion of the investigator make it difficult for the subject to comply with study procedures or follow instructions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Postmenopausal, topical vaginal cream	Postmenopausal, topical vaginal estrogen cream	Postmenopausal participants randomized to topical vaginal cream containing estrogen or placebo for about one month's use prior to scheduled surgery. These will include those women randomized to estrogen cream.

Primary Outcome Measures

Name	Time	Method
Vaginal epithelial thickness	1-month perioperative study	Measure of vaginal epithelial thickness obtained by optical coherence tomography

Secondary Outcome Measures

Name	Time	Method
Histologic assessment of excised tissue	1-month perioperative study	Evaluation of histology from surgery for collagen and elastin

Trial Locations

Locations (1)

UTMB Galveston; 🇺🇸 Galveston, Texas, United States