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

May 6, 2010
November 16, 2010
July 2009
December 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01123135 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
The Effect of Vaginal Estrogen Cream on Subjective and Objective Symptoms of Urodynamic Stress Incontinence
The Effect of Vaginal Estrogen Cream on Subjective and Objective Symptoms of Urodynamic Stress Incontinence

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.

  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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Urodynamic Stress Incontinence
  • Drug: Estrogen cream
    1gm of estrogen vaginal cream [EVC] at bed time 3 times a week
  • Drug: Placebo
    Placebo
  • Active Comparator: Vaginal ERT
    1gm of estrogen vaginal cream [EVC] at bed time 3 times a week
    Intervention: Drug: Estrogen cream
  • Placebo Comparator: Placebo
    1gm of placebo at bed time 3 times a week
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
108
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Female
Not Provided
No
Contact: Karen Noblett, MD 714.456.8564 knoblett@uci.edu
United States
 
NCT01123135
2008-6434
Yes
Karen Noblett, MD, UCI Medical Center
University of California, Irvine
Not Provided
Principal Investigator: Karen Noblett, MD UCI Medical Center
University of California, Irvine
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP