Hormonal Status on Blood Flow and Tissue in Pelvic Organ Prolapse

The University of Texas System (UT) logo

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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