Hormonal Status on Blood Flow and Tissue in Pelvic Organ Prolapse

Sponsor

The University of Texas Medical Branch, Galveston (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01886794

Collaborator

(none)

Enrollment

Location

Arms

138

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Pelvic Floor Disorders	Drug: Postmenopausal, topical vaginal estrogen cream Drug: Placebo Comparator: Postmenopausal, topical placebo cream	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Other

Official Title:

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

Study Start Date :

Jun 1, 2013

Anticipated Primary Completion Date :

May 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
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.	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. Other Names: Estrace vaginal 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.	Drug: Placebo Comparator: Postmenopausal, topical placebo cream Postmenopausal participants randomized to topical vaginal placebo for about one month's use prior to scheduled surgery. Other Names: Placebo vaginal cream

Arm

Intervention/Treatment

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.

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.

Other Names:

Estrace vaginal 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

Drug: Placebo Comparator: Postmenopausal, topical placebo cream

Postmenopausal participants randomized to topical vaginal placebo for about one month's use prior to scheduled surgery.

Other Names:

Placebo vaginal cream

Outcome Measures

Primary Outcome Measures

Vaginal epithelial thickness [1-month perioperative study]
Measure of vaginal epithelial thickness obtained by optical coherence tomography

Secondary Outcome Measures

Histologic assessment of excised tissue [1-month perioperative study]
Evaluation of histology from surgery for collagen and elastin

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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