Detrol LA vs Estrace Vaginal Cream for the Treatment of Overactive Bladder Symptoms
Information source: University of Alabama at Birmingham
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Overactive Bladder
Intervention: tolterodine LA (Drug); Estrace Vaginal Cream (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: University of Alabama at Birmingham Official(s) and/or principal investigator(s):
Kimberly Gerten, M.D., Principal Investigator, Affiliation: University of Alabama at Birmingham
Holly E. Richter, Ph.D., M.D., Study Director, Affiliation: University of Alabama at Birmingham
Overall contact:
Kathy Carter, RN, Phone: 205-934-1776, Email: kcarter@uab.edu
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: Treatment, Randomized, Double Blind (Caregiver, Investigator), Active Control, Crossover Assignment
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
Kathy Carter, RN, Phone: 205-934-1776, Email: kcarter@uab.edu
University of Alabama at Birmingham, Birmingham, Alabama 35233, United States; Recruiting
Kimberly Gerten, M.D., Principal Investigator
Additional Information
Starting date: April 2007
Ending date: December 2009
Last updated: June 3, 2008
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