Detrol LA vs Estrace Vaginal Cream for the Treatment of Overactive Bladder Symptoms (DRIVE)
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 Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Treatment
|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|
- 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 ] [ Designated as safety issue: No ]OAB-q scoring ranges from a lowest score of 8 to the highest score of 48. The higher score reflects greater severity of symptoms. The derived score is (Actual score - lowest raw score) divided by possible raw score range (40) times 100. Hence the lowest score is 0 and highest score is 100, with 100 being indicative of greater symptom severity. The mean and the standard deviation is reported for both arms.
- Subjective Patient Improvement in Irritative Urinary Symptoms at 1 Year of Treatment by the OAB-Q Questionnaire [ Time Frame: after 1 year of treatment ] [ Designated as safety issue: No ]
|Study Start Date:||April 2007|
|Study Completion Date:||December 2011|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
Active Comparator: 1
Women who also have some stress urinary symptoms as reported on the MESA questionnaire
Drug: Tolterodine LA
Tolterodine LA 4 mg once daily for 52 weeks
Active Comparator: 2
Women with only urge urinary symptoms
Drug: Estrace Vaginal Cream
17-B estradiol cream 0.5 grams nightly for 6 weeks then two times weekly for 46 weeks
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
|Principal Investigator:||Kimberly Gerten, M.D.||Park Nicollette, St. Louis, Minnesota|
|Principal Investigator:||Holly E. Richter, Ph.D., M.D.||University of Alabama at Birmingham|