The Effect of Vaginal Estrogen Cream on Subjective and Objective Symptoms of Urodynamic Stress Incontinence

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by University of California, Irvine.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT01123135
First received: May 6, 2010
Last updated: November 16, 2010
Last verified: November 2010
  Purpose

This is a randomized, double blinded placebo controlled trial over a period of 3 months. Study subjects will be randomized into 2 groups: Those receiving drug (1gm of estrogen vaginal cream [EVC] at bed time 3 times a week), and those receiving placebo.


Condition Intervention
Urodynamic Stress Incontinence
Drug: Estrogen cream
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Vaginal Estrogen Cream on Subjective and Objective Symptoms of Urodynamic Stress Incontinence

Resource links provided by NLM:


Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • To determine the effects of vaginal estrogen replacement versus placebo on the subjective improvement of stress urinary incontinence symptoms with the use of validated questionnaires. [ Time Frame: Exam at baseline and 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determine effects of vaginal ERT vs placebo on objective improvement in urethral function by comparing pre and post treatment urethral closure pressures. Determine incidence of UTIs at the beginning of study compared to the end of the study. [ Time Frame: Exam at baseline and 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 108
Study Start Date: July 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vaginal ERT
1gm of estrogen vaginal cream [EVC] at bed time 3 times a week
Drug: Estrogen cream
1gm of estrogen vaginal cream [EVC] at bed time 3 times a week
Placebo Comparator: Placebo
1gm of placebo at bed time 3 times a week
Drug: Placebo
Placebo

Detailed Description:
  1. This will be a randomized, double blinded placebo controlled trial over a period of 3 months. Study subjects will be randomized into 2 groups: Those receiving drug (1gm of estrogen vaginal cream [EVC] at bed time 3 times a week), and those receiving placebo. Study subjects will be patients diagnosed with stress urinary incontinence by urodynamic evaluation. They will have filled out the IIQ-7 and UDI-6 validated questionnaires as is routine for all patients being evaluated for stress incontinence. After enrollment and informed consent, their initial screening will include a Pap smear for vaginal maturation.
  2. Subjects will then be seen at 4, 8 and 12 weeks. At each visit, they will turn in their medication tubes and receive new study medication. They will also be screened for any adverse reaction to the study medication at each visit.
  3. At the end of the study period, the subjects will fill out the same validated questionnaire as they did at the beginning of the study and they will also have their urethral pressure profile and PAP smear repeated.
  4. The urethral pressure profile is part of the standard complex urodynamic testing that all patients undergo for evaluation and diagnosis of urodynamic stress incontinence. Urethral Pressure Profile is a technique used to provide information about the ability of the urethra to prevent leakage. The Urethral Pressure Profile is a specific study, in which a special design catheter is pulled through the urethra at a slow, continuous rate. The resulting "bell shaped" curve illustrates the function of the urethra from the beginning of the bladder neck out through the meatus.
  5. The placebo cream will be a pharmacologically inert formulation which will be packaged similarly to the active premarin cream and visually indistinguishable from the active drug to both the study subjects and researchers.
  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • English speaking
  • Postmenopausal women (No menses for a minimum period of 1 year)
  • Urodynamic stress urinary incontinence

Exclusion Criteria:

  • History of breast or uterine cancer
  • History of venous thrombolic event
  • Hormone replacement therapy within 3 months of study
  • Sensitivity or allergy to premarin cream
  • Current use of any medications for urge or stress incontinence
  • Prior surgery for stress incontinence
  • Overactive bladder or Detrussor instability
  • Active vaginal/ bladder infection (patients will be treated and have a negative test for cure in order to be enrolled in the study)
  • History of pelvic or vaginal radiation therapy
  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: NCT01123135

Contacts
Contact: Karen Noblett, MD 714.456.8564 knoblett@uci.edu

Locations
United States, California
UC Irvine Women's Healthcare Recruiting
Orange, California, United States, 92868
Contact: Karen Knoblett, MD    714-456-8564    knoblett@uci.edu   
Principal Investigator: Karen Noblett, MD         
Sub-Investigator: Ene George, MD         
Sub-Investigator: Danielle Markle, MD         
Sub-Investigator: Jennifer Lee, MD         
Sponsors and Collaborators
University of California, Irvine
Investigators
Principal Investigator: Karen Noblett, MD UCI Medical Center
  More Information

No publications provided

Responsible Party: Karen Noblett, MD, UCI Medical Center
ClinicalTrials.gov Identifier: NCT01123135     History of Changes
Other Study ID Numbers: 2008-6434
Study First Received: May 6, 2010
Last Updated: November 16, 2010
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by University of California, Irvine:
urodynamic stress incontinence
postmenopausal women

Additional relevant MeSH terms:
Urinary Incontinence, Stress
Urinary Incontinence
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014