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NCT01666405 · ClinicalTrials.gov registry record · Phase 1
Prospective, Multicenter Trial to Investigate the Safety and Efficacy of Percutaneous Tibial Nerve Stimulation for the Treatment of Fecal Incontinence
A Phase 1 study, sponsored by Uroplasty.
- Terminated
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT01666405: Clinical Trial Phase 1 study, sponsored by Uroplasty.
NCT01666405 is a Phase 1 study that was terminated before completion, run by Uroplasty. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01666405, a Phase 1 study, was terminated before completion, sponsored by Uroplasty.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the effectiveness of percutaneous tibial nerve stimulation (PTNS) therapy with the Urgent® PC Neuromodulation System (Uroplasty, Inc., Minnetonka, MN, USA) for the treatment of fecal incontinence (FI).
Primary Outcome
To assess the effectiveness of PTNS by measuring the proportion of patients with ≥50% decrease in the number of fecal incontinence episodes per week based on the results of the 14-day bowel diary at 18 weeks compared to baseline
Interventions
- DEVICE Urgent(R) PC Neuromodulation System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2012-08 |
| Est. Completion | 2015-04 |
| Phase | Phase 1 |
Why NCT01666405 stopped before completion
NCT01666405 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 1 intervention - of which Urgent(R) PC Neuromodulation System is the first listed.
NCT01666405 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01666405 about?
NCT01666405 is a clinical study titled "Prospective, Multicenter Trial to Investigate the Safety and Efficacy of Percutaneous Tibial Nerve Stimulation for the Treatment of Fecal Incontinence". The purpose of this study is to determine the effectiveness of percutaneous tibial nerve stimulation (PTNS) therapy with the Urgent® PC Neuromodulation System (Uroplasty, Inc., Minnetonka, MN, USA) for the treatment of fecal incontinence (FI).
What is the current status of trial NCT01666405?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2012-08. Estimated completion is 2015-04.
What interventions are being tested in trial NCT01666405?
The interventions under investigation include: Urgent(R) PC Neuromodulation System (DEVICE).
Who is sponsoring clinical trial NCT01666405?
This trial is sponsored by Uroplasty, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01666405's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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