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Detrol LA vs Estrace Vaginal Cream for the Treatment of Overactive Bladder Symptoms

Information source: University of Alabama at Birmingham
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Overactive Bladder

Intervention: Tolterodine LA (Drug); Estrace Vaginal Cream (Drug)

Phase: N/A

Status: Completed

Sponsored by: University of Alabama at Birmingham

Official(s) and/or principal investigator(s):
Kimberly Gerten, M.D., Principal Investigator, Affiliation: Park Nicollette, St. Louis, Minnesota
Holly E. Richter, Ph.D., M.D., Principal Investigator, Affiliation: University of Alabama at Birmingham

Summary

The purpose of this study is to determine if long acting tolterodine confers more benefit than intravaginal low dose estrogen in the treatment of Overactive Bladder Syndrome at 12 weeks post-treatment initiation. The hypothesis is that low dose intra-vaginal estrogen confers greater benefit than tolterodine in the treatment of Overactive Bladder symptoms.

Clinical Details

Official title: Randomized Controlled Trial of Tolterodine in Combination With or Without Low-Dose Intra-Vaginal Estradiol Cream for the Treatment of Overactive Bladder in Post-Menopausal Women

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Subjective Patient Improvement in Irritative Urinary Symptoms as Measured by the Overactive Bladder Questionnaire (OAB-q) After 12 Weeks Intervention

Secondary outcome: Subjective Patient Improvement in Irritative Urinary Symptoms at 1 Year of Treatment by the OAB-Q Questionnaire

Detailed description: Lower urinary tract bladder storage symptoms include urinary frequency, urinary urgency, nocturia and urge incontinence. Overactive Bladder (OAB)Syndrome is a condition in which urgency is the predominant symptom with or without urge incontinence and is usually accompanied by frequency and nocturia. The mainstay of treatment of women with OAB syndrome is treatment with anticholinergic medication as well as behavioral therapy. This method of treatment has demonstrated a 60% response rate as reported in the Cochrane Database of Systemic Reviews. In addition to anticholinergic therapy, vaginal atrophy is often corrected as part of a pharmacologic treatment plan. Vaginal atrophy is a condition this is vastly prevalent in post-menopausal women. It is thought to affect up to 48% of post-menopausal women. Many women with this condition experience vaginal dryness, irritation, painful intercourse, as well as urinary symptoms including dysuria, urgency, frequency, nocturia, incontinence and recurrent urinary tract infections. Comparison: Tolterodine LA compared to low dose intra-vaginal estrogen cream for the treatment of OAB symptoms

Eligibility

Minimum age: 40 Years. Maximum age: 90 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Irritative voiding symptoms to include sensory urgency, frequency, urge incontinence,

nocturia

- Postmenopausal women with a prior oophorectomy or 1 year from last menstrual period

- Women age 40-90

- Women with hysterectomy with preserved ovaries must be age 55 or greater or have a

documented FSH>40 to ensure post-menopausal status

- Community dwelling

- Ambulatory

- Ability to participate in a 12 month study

Exclusion Criteria:

- Post-void residual volume>150ml

- Glaucoma without ophthalmologist clearance

- Hormone replacement therapy in the past 6 months

- Current anticholinergic treatment

- Breast cancer

- Impaired mental status

- Undiagnosed vaginal bleeding in the past 12 months

- Endometrial thickness on pelvic ultrasound >5mm

- History of thromboembolic event

- Gynecologic cancer

- Untreated urinary tract infection (would be eligible after treatment) Stage III

pelvic organ prolapse or greater

- Recent diuretic medication changes (one month from change)

- Neurologic condition affecting bladder function (Multiple Sclerosis, Parkinsons,

spinal cord injury, spina bifida)

- Congestive heart failure

- Prior pelvic irradiation

- Interstitial cystitis

Locations and Contacts

Additional Information

Starting date: April 2007
Last updated: September 21, 2012

Page last updated: August 23, 2015

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