Hormonal Status on Blood Flow and Tissue in Pelvic Organ Prolapse

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-06

Study Completion Date

2023-12-11

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pelvic Floor Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Postmenopausal, topical vaginal estrogen cream

Intervention Type DRUG

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type PLACEBO_COMPARATOR

Placebo Comparator: Postmenopausal, topical placebo cream

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Placebo Comparator: Postmenopausal, topical placebo cream

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

Intervention Type DRUG

Other Intervention Names

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Estrace vaginal cream Placebo vaginal cream

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No