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Understanding the Response to Fesoterodine Through Genetic Evaluation in the Elderly (URGE)
Urge urinary incontinence, characterized by unpredictable and embarrassing large volume urine leakage, is a major health issue for elderly women, as it is incredibly common and significantly impairs quality of life. Although anticholinergic medications are the most common therapy, the investigators are unable to predict an individual's response to a particular drug in terms of both effectiveness and side effects. Through genetic evaluation, the investigators have the potential to personalize and optimize drug therapy for millions of elderly women suffering from urge incontinence.
Details
| Lead sponsor | University of North Carolina, Chapel Hill |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 61 |
| Start date | 2012-09 |
| Completion | 2017-12-31 |
Conditions
- Urge Urinary Incontinence
Interventions
- Fesoterodine Fumarate
Primary outcomes
- Percentage With Treatment Success — 4 weeks
Treatment Success (Yes/No) was defined by the Treatment Benefit Scale (TBS). TBS is a 4-point scale which was dichotomized into Yes/No for the Treatment Success outcome. The scale asks participants to rate "My condition has been improved: 1= greatly improved, 2=improved, 3=not changed, 4= worsened." If a participant responded 1 (greatly improved) or 2 (improved), they were considered as a "Yes" for Treatment Success. If a participant responded 3 (not changed) or 4 (worsened), then they were considered as a "No" for Treatment Success.
Countries
United States