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Hormonal Status on Blood Flow and Tissue in Pelvic Organ Prolapse

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ClinicalTrials.gov Identifier: NCT01886794
Recruitment Status : Recruiting
First Posted : June 26, 2013
Last Update Posted : May 3, 2017
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston

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.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Official Title: Role of Hormonal Status on Vascularization and Vaginal Tissue in Women With Pelvic Organ Prolapse
Study Start Date : June 2013
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Composite of vaginal wall inflammatory markers and macrocirculatory and microcirculatory flow on pelvic floor dysfunction [ Time Frame: 1-month perioperative study ]

Secondary Outcome Measures :
  1. Composite of tissue matrix metalloproteinases, collagen/elastin structure, microvasculature and muscle thickness [ Time Frame: 1-month perioperative study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01886794

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

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 Medical Branch, Galveston
Principal Investigator: Tristi Muir, MD UTMB Galveston

Additional Information:
Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT01886794     History of Changes
Other Study ID Numbers: 13-114
First Posted: June 26, 2013    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: December 2016

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

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