Randomized Controlled Trial of Tolterodine in Combination With or Without Low-Dose Intravaginal Estradiol Cream for the Treatment of Overactive Bladder in Post-Menopausal Women (DRIVE)

NCT00465894 NA COMPLETED Results posted

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.

Details

Lead sponsor	University of Alabama at Birmingham
Phase	NA
Status	COMPLETED
Enrolment	58
Start date	2007-04
Completion	2011-12

Conditions

• Overactive Bladder

Interventions

• Extended Release Tolterodine LA
• Intra Vaginal Estradiol Cream

Primary outcomes

• Evaluate Subjective Patient Change in Irritative Urinary Symptoms as Measured by the Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score — From baseline through 12 Weeks of Intervention
  The first part of the OAB-q consists of eight questions assessing symptom bother with a possible score from 0 to 100 with a higher score indicating greater symptom bother.