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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Caregiver, Investigator), Active Control, Crossover Assignment

Study Primary Completion Date: November 2009

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

Intervention(s) in this Clinical Trial

• Drug: tolterodine LA
  • tolterodine LA 4 mg once daily for 52 weeks
• Drug: Estrace Vaginal Cream
  • 17-B estradiol cream 0.5 grams nightly for 6 weeks then two times weekly for 46 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Women who also have some stress urinary symptoms as reported on the MESA questionnaire
• Active Comparator: 2
  • Women with only urge urinary symptoms

Primary Measures

• Subjective patient improvement in irritative urinary symptoms as measured by the Overactive Bladder Questionnaire (OAB-q) after 12 weeks intervention
  • Time Frame: after 12 weeks of intervention
    Safety Issue?: No

Secondary Measures

• Subjective patient improvement in irritative urinary symptoms at 1 year of treatment by the OAB-Q questionnaire
  • Time Frame: after 1year of treatment
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: 90 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: University of Alabama at Birmingham

Overall Clinical Trial Officials and Contacts

Kimberly Gerten, M.D. Principal Investigator University of Alabama at Birmingham  

Overall Contact: Kathy Carter, RN 205-934-1776 kcarter@uab.edu

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00465894

Study ID Number: F061208008

ClinicalTrials.gov Identifier: NCT00465894

Health Authority: United States: Institutional Review Board