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
Recruitment status was Recruiting
Sponsor:
University of California, Irvine
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
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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:
- 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.
- 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.
- 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.
- 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.
- 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
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 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 May 23, 2013