Hormonal Status on Blood Flow and Tissue in Pelvic Organ Prolapse

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by The University of Texas, Galveston
Sponsor:
Information provided by (Responsible Party):
The University of Texas, Galveston
ClinicalTrials.gov Identifier:
NCT01886794
First received: June 14, 2013
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Pelvic Floor Disorders
Drug: Topical Vaginal Estrogen Cream/placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Official Title: Role of Hormonal Status on Vascularization and Vaginal Tissue in Women With Pelvic Organ Prolapse

Resource links provided by NLM:


Further study details as provided by The University of Texas, Galveston:

Primary Outcome Measures:
  • Composite of vaginal wall inflammatory markers and macrocirculatory and microcirculatory flow on pelvic floor dysfunction [ Time Frame: 1-month perioperative study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Composite of tissue matrix metalloproteinases, collagen/elastin structure, microvasculature and muscle thickness [ Time Frame: 1-month perioperative study ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: June 2013
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: Topical Vaginal Estrogen Cream/placebo
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.
Other Name: Premarin, Estrace
No Intervention: Pre-menopausal, no topical vaginal cream

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01886794

Contacts
Contact: Carrie Derkowski, BS 409-772-5164 caderkow@utmb.edu

Locations
United States, Texas
UTMB Speciality Care Center at Victory Lakes Recruiting
League City, Texas, United States, 77573
Contact: Tristi Muir, MD    409-747-6625    trmuir@utmb.edu   
Principal Investigator: Kathleen L Vincent, MD         
Sub-Investigator: Erin Conroy, MD         
Sponsors and Collaborators
The University of Texas, Galveston
Investigators
Principal Investigator: Tristi Muir, MD UTMB Galveston
  More Information

Additional Information:
No publications provided

Responsible Party: The University of Texas, Galveston
ClinicalTrials.gov Identifier: NCT01886794     History of Changes
Other Study ID Numbers: 13-114
Study First Received: June 14, 2013
Last Updated: April 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas, Galveston:
pelvic floor dysfunction
pelvic organ prolapse
vaginal estrogen effects

Additional relevant MeSH terms:
Pelvic Floor Disorders
Pelvic Organ Prolapse
Prolapse
Pathological Conditions, Anatomical
Pregnancy Complications
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 29, 2014