Status:
TERMINATED
Hormonal Status on Blood Flow and Tissue in Pelvic Organ Prolapse
Lead Sponsor:
The University of Texas Medical Branch, Galveston
Conditions:
Pelvic Floor Disorders
Eligibility:
FEMALE
21-70 years
Phase:
PHASE4
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 f...
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 f...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 6 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 11 2023
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT01886794
Start Date
June 6 2013
End Date
December 11 2023
Last Update
October 29 2025
Active Locations (1)
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1
UTMB Galveston
Galveston, Texas, United States, 77550