Hormonal Status on Blood Flow and Tissue in Pelvic Organ Prolapse

• Status: Active, not recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Medical Branch, Galveston
• Treatments: Estrogens; Estrogens, Conjugated (USP)

Criteria

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