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

NCT01123135 | Withdrawn DMC

• 1 other identifier: 2008-6434
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Urinary Incontinence

Keywords

urodynamic stress incontinence; postmenopausal women

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

Vaginal ERT

ACTIVE COMPARATOR

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

Drug: Vaginal ERT

Placebo

PLACEBO COMPARATOR

1gm of placebo at bed time 3 times a week

Drug: Placebo

Interventions

Vaginal ERT DRUG

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

Vaginal ERT

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• English speaking
• Postmenopausal women (No menses for a minimum period of 1 year)
• Urodynamic stress urinary incontinence

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

UC Irvine Women's Healthcare

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Karen Noblett, MD

  UCI Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2010
• First Posted: May 14, 2010
• Study Start: July 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: March 26, 2021

Record last verified: 2021-03

Locations

US (1)