Detrol Long Acting (LA) vs Estrace Vaginal Cream for the Treatment of Overactive Bladder Symptoms

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: Female

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. Secondary outcomes were to assess if the addition of the other therapy to the treatment regimen conferred benefit at 24 weeks and 52 weeks.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Alabama at Birmingham
• Collaborator: Pfizer
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Polyestradiol phosphate; Tolterodine Tartrate

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 follicle-stimulating hormone (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