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Hormonal Status on Blood Flow and Tissue in Pelvic Organ Prolapse

Primary Purpose

Pelvic Floor Disorders

Status
Active
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Postmenopausal, topical vaginal estrogen cream
Placebo Comparator: Postmenopausal, topical placebo cream
Sponsored by
The University of Texas Medical Branch, Galveston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pelvic Floor Disorders focused on measuring pelvic floor dysfunction, pelvic organ prolapse, vaginal estrogen effects

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • UTMB Galveston

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Placebo Comparator

Arm Label

Postmenopausal, topical vaginal cream

Pre-menopausal, no topical vaginal cream

Postmenopausal, topical placebo cream

Arm 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.

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 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.

Outcomes

Primary Outcome Measures

Vaginal epithelial thickness
Measure of vaginal epithelial thickness obtained by optical coherence tomography

Secondary Outcome Measures

Histologic assessment of excised tissue
Evaluation of histology from surgery for collagen and elastin

Full Information

First Posted
June 14, 2013
Last Updated
February 14, 2023
Sponsor
The University of Texas Medical Branch, Galveston
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1. Study Identification

Unique Protocol Identification Number
NCT01886794
Brief Title
Hormonal Status on Blood Flow and Tissue in Pelvic Organ Prolapse
Official Title
Role of Hormonal Status on Vascularization and Vaginal Tissue in Women With Pelvic Organ Prolapse
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 2013 (undefined)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Medical Branch, Galveston

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Floor Disorders
Keywords
pelvic floor dysfunction, pelvic organ prolapse, vaginal estrogen effects

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Postmenopausal, topical vaginal cream
Arm Type
Experimental
Arm 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.
Arm Title
Pre-menopausal, no topical vaginal cream
Arm Type
No Intervention
Arm 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.
Arm Title
Postmenopausal, topical placebo cream
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Postmenopausal, topical vaginal estrogen cream
Other Intervention Name(s)
Estrace vaginal cream
Intervention Description
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
Intervention Name(s)
Placebo Comparator: Postmenopausal, topical placebo cream
Other Intervention Name(s)
Placebo vaginal cream
Intervention Description
Postmenopausal participants randomized to topical vaginal placebo for about one month's use prior to scheduled surgery.
Primary Outcome Measure Information:
Title
Vaginal epithelial thickness
Description
Measure of vaginal epithelial thickness obtained by optical coherence tomography
Time Frame
1-month perioperative study
Secondary Outcome Measure Information:
Title
Histologic assessment of excised tissue
Description
Evaluation of histology from surgery for collagen and elastin
Time Frame
1-month perioperative study

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen Vincent, MD
Organizational Affiliation
UTMB Galveston
Official's Role
Principal Investigator
Facility Information:
Facility Name
UTMB Galveston
City
Galveston
State/Province
Texas
ZIP/Postal Code
77550
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.utmbhealth.com/PelvicHealth
Description
Link to the clinic where recruitment will be performed

Learn more about this trial

Hormonal Status on Blood Flow and Tissue in Pelvic Organ Prolapse

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