Hormonal Status on Blood Flow and Tissue in Pelvic Organ Prolapse
Purpose
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.
Condition
- Pelvic Floor Disorders
Eligibility
- Eligible Ages
- Between 21 Years and 70 Years
- Eligible Genders
- Female
- Accepts Healthy Volunteers
- No
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
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Other
- Masking
- Triple (Participant, Care Provider, Investigator)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Postmenopausal, topical vaginal 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. |
|
No Intervention Pre-menopausal, no topical vaginal cream |
Pre-menopausal, no topical vaginal cream. These women will be examined at different stages in their menstrual cycle in order to compare characteristics of the cycle at high and lower estrogen timepoints. |
|
Placebo Comparator Postmenopausal, topical placebo 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 placebo. |
|
More Details
- Status
- Terminated
- Sponsor
- The University of Texas Medical Branch, Galveston
Study Contact
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.