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NCT02176642 · ClinicalTrials.gov registry record · Phase 4
Comparison of Combination Therapy vs Single Agent Therapy for Treatment of Urge Incontinence.
A Phase 4 study, sponsored by Duke University.
- Terminated
- Registry status
- Phase 4
- Development phase
- 55
- Enrollment target
NCT02176642 is a Phase 4 study that was terminated before completion, run by Duke University. The registered enrollment target is 55 participants.
The verdict
NCT02176642, a Phase 4 study, was terminated before completion, sponsored by Duke University.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 55 participants
- Enrollment target
Study Summary
This is a randomized double-blind placebo-controlled clinical trial of posterior tibial nerve stimulation (PTNS) plus extended release oxybutynin versus PTNS alone (placebo pills) in women undergoing treatment of urgency urinary incontinence (UUI). The investigators hypothesize that combination therapy with PTNS and anticholinergic medication will result in a significant incremental improvement in UUI symptoms over that achieved with PTNS alone. In addition, the investigators hypothesize that the addition of anticholinergics to PTNS will result in a greater improvement in patients' perception of treatment response, symptom distress, and quality of life than PTNS alone. Specific Aim 1: To compare the change, from baseline, in mean number of UUI episodes per day using a 3-day bladder diary between PTNS plus anticholinergic medication versus PTNS plus placebo in women undergoing treatment for UUI. Specific Aim 2: To compare the change, from baseline, in a 24hr pad weight between PTNS plus anticholinergic medication versus PTNS plus placebo. Specific Aim 3: To compare subjective treatment response, symptoms distress, and quality of life between PTNS plus anticholinergic medication versus PTNS plus placebo utilizing the Patient Global Impression of Improvement (PGI-I) and the Overactive Bladder Questionnaire Short Form (OABq-SF). An interim analysis will be conducted by an independent entity after 50 participants have completed the study protocol. A Data Safety Monitoring Board is not utilized because the study utilizes FDA approved treatments for urgency urinary incontinence.
Interventions
- DRUG Placebo
- DEVICE Posterior Tibial Nerve Stimulation
- DRUG Oxybutynin extended release
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2014-08 |
| Est. Completion | 2016-11-21 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02176642
The ClinicalTrials.gov registry entry for NCT02176642 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02176642 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02176642 about?
NCT02176642 is a clinical study titled "Comparison of Combination Therapy vs Single Agent Therapy for Treatment of Urge Incontinence.". This is a randomized double-blind placebo-controlled clinical trial of posterior tibial nerve stimulation (PTNS) plus extended release oxybutynin versus PTNS alone (placebo pills) in women undergoing treatment of urgency urinary incontinence (UUI). The investigators hypothesize that combination the...
What is the current status of trial NCT02176642?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 55 participants. The study started on 2014-08. Estimated completion is 2016-11-21.
What interventions are being tested in trial NCT02176642?
The interventions under investigation include: Placebo (DRUG), Posterior Tibial Nerve Stimulation (DEVICE), Oxybutynin extended release (DRUG).
Who is sponsoring clinical trial NCT02176642?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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