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NCT01786967 · ClinicalTrials.gov registry record · Phase 3

Understanding the Response to Fesoterodine Through Genetic Evaluation in the Elderly (URGE)

A Phase 3 study, sponsored by University of North Carolina, Chapel Hill.

Completed
Registry status
Phase 3
Development phase
61
Enrollment target

NCT01786967: Completed Phase 3 study, sponsored by University of North Carolina, Chapel Hill.

NCT01786967 is a Phase 3 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 61 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01786967, a Phase 3 study, has completed, sponsored by University of North Carolina, Chapel Hill.

COMPLETED
Registry status
Phase 3
Development phase
61 participants
Enrollment target

Study Summary

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.

Primary Outcome

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 cons

Interventions

  • DRUG Fesoterodine Fumarate

Trial Details

FieldValue
Enrollment Target 61 participants
Start Date 2012-09
Est. Completion 2017-12-31
Phase Phase 3

What the finished NCT01786967 record still lists

NCT01786967 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).

The record links to 0 conditions, and to 1 intervention - of which Fesoterodine Fumarate is the first listed.

NCT01786967 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01786967 about?

NCT01786967 is a clinical study titled "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 ...

What is the current status of trial NCT01786967?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 61 participants. The study started on 2012-09. Estimated completion is 2017-12-31.

What interventions are being tested in trial NCT01786967?

The interventions under investigation include: Fesoterodine Fumarate (DRUG).

Who is sponsoring clinical trial NCT01786967?

This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01786967's enrollment target sits among peer trials

61 1803rd of 2000 higher than 197 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01786967, the US trial registry maintained by the National Library of Medicine. NCT01786967 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.