Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Clinical Trial Phase 4 study, sponsored by Duke University.
NCT02176642 is a Phase 4 study that was terminated before completion, run by Duke University. The registered enrollment target is 55 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To compare the change, from baseline, in median 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. UUI change score will be calculated \[post-treatment UUI/day minus pre-treatment UUI/day\].
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 |
Why NCT02176642 stopped before completion
NCT02176642 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02176642 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02176642's enrollment target sits among peer trials
55 1218th of 2000 higher than 778 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01638676 · 55 participants · Phase 1
A Phase I/II Trial of Vemurafenib and Metformin to Melanoma Patients
- NCT01906385 · 55 participants · Phase 1
Maximum Tolerated Dose, Safety, and Efficacy of Rhenium Nanoliposomes in Recurrent Glioma (ReSPECT)
- NCT03007030 · 55 participants · Phase 2
Brentuximab Vedotin in Treating Patients With CD30+ Malignant Mesothelioma That Cannot Be Removed by Surgery
- NCT03152058 · 55 participants · Phase 2
IMPACT Study: IMProve Pregnancy in APS With Certolizumab Therapy
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia