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

Sponsor

University of California, Irvine (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01123135

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stress Urinary Incontinence	Drug: Vaginal ERT Drug: Placebo	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 1, 2009

Actual Primary Completion Date :

May 1, 2010

Actual Study Completion Date :

May 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Vaginal ERT Vaginal ERT cream 1 gm at bed time 3 times a week	Drug: Vaginal ERT 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

Arm

Intervention/Treatment

Active Comparator: Vaginal ERT

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

Drug: Vaginal ERT

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

Outcome Measures

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. [Exam at baseline and 12 weeks]

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. [Exam at baseline and 12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UC Irvine Women's Healthcare	Orange	California	United States	92868

Sponsors and Collaborators

University of California, Irvine

Investigators

Principal Investigator: Karen Noblett, MD, UCI Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of California, Irvine

ClinicalTrials.gov Identifier:

NCT01123135

Other Study ID Numbers:

2008-6434

First Posted:

May 14, 2010

Last Update Posted:

Mar 26, 2021

Last Verified:

Mar 1, 2021

Keywords provided by University of California, Irvine

urodynamic stress incontinence

postmenopausal women

Additional relevant MeSH terms:

Urinary Incontinence

Urinary Incontinence, Stress

Study Results

No Results Posted as of Mar 26, 2021