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Unable to determine a suitable placebo.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaginal ERT | Active Comparator | Vaginal ERT cream 1 gm at bed time 3 times a week |
|
| Placebo | Placebo Comparator | 1gm of placebo at bed time 3 times a week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaginal ERT | Drug | 1gm of estrogen vaginal cream [EVC] at bed time 3 times a week |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Exam at baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Exam at baseline and 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen Noblett, MD | UCI Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Irvine Women's Healthcare | Orange | California | 92868 | United States |
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| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Placebo |
| Drug |
Placebo |
|
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |