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

NCT ID: NCT01123135

Last Updated: 2021-03-26

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2010-05-31

Brief Summary

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.

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.

Conditions

Stress Urinary Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Vaginal ERT

Vaginal ERT cream 1 gm at bed time 3 times a week

Group Type: ACTIVE_COMPARATOR

Vaginal ERT

Intervention Type: DRUG

1gm of estrogen vaginal cream \[EVC\] at bed time 3 times a week

Placebo

1gm of placebo at bed time 3 times a week

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Interventions

Vaginal ERT

1gm of estrogen vaginal cream \[EVC\] at bed time 3 times a week

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Eligibility 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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karen Noblett, MD

Role: PRINCIPAL_INVESTIGATOR

UCI Medical Center

Locations

UC Irvine Women's Healthcare

Orange, California, United States

Countries

United States

Other Identifiers

2008-6434

Identifier Type: -

Identifier Source: org_study_id