WithdrawnNot Applicable

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

Stopped: Unable to determine a suitable placebo.

United States0Started 2009-07

Plain-language 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.

Who can participate

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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.

Timeframe: Exam at baseline and 12 weeks

Trial details

NCT IDNCT01123135

SponsorUniversity of California, Irvine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-05

View on ClinicalTrials.gov More Stress Urinary Incontinence trials

Who can participate

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.