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

University of California Irvine (UCI)

Status: Withdrawn

Conditions: Stress Urinary Incontinence

Treatments: Drug: Vaginal ERT; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01123135

2008-6434

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

Vaginal ERT

Active Comparator group

Description:

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

Treatment:

Drug: Vaginal ERT

Placebo

Placebo Comparator group

Description:

1gm of placebo at bed time 3 times a week

Treatment:

Drug: Placebo