At a glance

ClinicalIndex Comparison Record

N/ACompleted· 307 enrolled

Drug / intervention

Tolterodine +1 moredrug

Likely dose

Tolterodine 4 mg once daily for 10 weeks (may be reduced to 2 mg daily for side effect management)AI-extracted

Key inclusion· 4

✓Female sex
✓Urge-predominant urinary incontinence
✓Incontinence symptoms for more than 3 months
✓Available for 8 months of follow-up

Key exclusion· 4

✕Pregnant or less than 6 months post-partum
✕Hypersensitivity or allergy to tolterodine
✕Systemic disease affecting bladder function (e.g., Parkinson's disease, Multiple Sclerosis, spinal cord injury)
✕Prior extensive behavioral treatment for incontinence

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00090584

NCT00090584N/ACompleted

Compare CT.gov

Behavior Enhances Drug Reduction of Incontinence

Carelon Research·interventional·Posted Aug 31, 2004·Updated Jun 17, 2013

In Brief

A clinical study evaluating Tolterodine and Behavioral training for Urinary Incontinence (UI). Completed, enrolled 307 participants across 9 sites.

Detailed Summary

The primary aim of this study is to test if the addition of behavioral treatment to drug therapy for the treatment of urge incontinence will increase the number of patients who can discontinue drug therapy and sustain a significant reduction of incontinence.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsUrinary Incontinence (UI)

CountriesUnited States

CollaboratorsEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Timeline

N/ACompletedFinished

200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartAug 2004

First PostedAug 2004

Primary CompletionDec 2005

Study CompletionAug 2006

TodayJul 2026

First PostedAug 31, 2004

Enrollment StartAug 1, 2004

Primary CompletionDec 1, 2005

Study CompletionAug 1, 2006

TodayJul 2, 2026

Enrollment to primary: 1.3 yearsPosted 21.8 years ago

Interventions

Tolterodinedrug

4mg/d for 10 weeks. Could be reduced to 2mg/d for managing side effects.

Behavioral trainingbehavioral

Training in pelvic floor muscle control and exercises; behavioral strategies to diminish urgency, suppress bladder contractions and prevent incontinence; delayed voiding; and individualized fluid management.