Hormonal Status on Blood Flow and Tissue in Pelvic Organ Prolapse

Pelvic Floor Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01886794
• Other study ID #: 13-114
• Status: Terminated
• Phase: Phase 4
• Start date: June 6, 2013
• Est. completion date: December 11, 2023

Study information

• Verified date: March 2024
• Source: The University of Texas Medical Branch, Galveston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: December 11, 2023
• Est. primary completion date: December 11, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Floor Disorders
• Pelvic Organ Prolapse
• Prolapse

Intervention

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.
• Placebo Comparator: Postmenopausal, topical placebo cream
Postmenopausal participants randomized to topical vaginal placebo for about one month's use prior to scheduled surgery.

Locations

Country	Name	City	State
United States	UTMB Galveston	Galveston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vaginal epithelial thickness	Measure of vaginal epithelial thickness obtained by optical coherence tomography	1-month perioperative study
Secondary	Histologic assessment of excised tissue	Evaluation of histology from surgery for collagen and elastin	1-month perioperative study

External Links

•   Link to the clinic where recruitment will be performed