Hormonal Status on Blood Flow and Tissue in Pelvic Organ Prolapse

The University of Texas System (UT)

Status and phase: Terminated; Phase 4

Conditions: Pelvic Floor Disorders

Treatments: Drug: Postmenopausal, topical vaginal estrogen cream; Drug: Placebo Comparator: Postmenopausal, topical placebo cream

Study type: Interventional

Funder types: Other

Identifiers

NCT01886794

13-114

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: Female

Ages: 21 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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10 participants in 3 patient groups, including a placebo group

Postmenopausal, topical vaginal cream

Experimental group

Description:

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.

Treatment:

Drug: Postmenopausal, topical vaginal estrogen cream

Pre-menopausal, no topical vaginal cream

No Intervention group

Description:

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.

Postmenopausal, topical placebo cream

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo Comparator: Postmenopausal, topical placebo cream