Status:
COMPLETED
Detrol Long Acting (LA) vs Estrace Vaginal Cream for the Treatment of Overactive Bladder Symptoms
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
Pfizer
Conditions:
Overactive Bladder
Eligibility:
FEMALE
40-90 years
Phase:
NA
Brief 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...
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 predomi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT00465894
Start Date
April 1 2007
End Date
December 1 2011
Last Update
November 1 2018
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