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NCT01274585 · ClinicalTrials.gov registry record · NA
Does Percutaneous Tibial Nerve Stimulation (PTNS) Improve Outcomes in Patients Presenting With Fecal Incontinence
A NA study, sponsored by Massachusetts General Hospital.
- Terminated
- Registry status
- NA
- Development phase
- 5
- Enrollment target
NCT01274585: Clinical Trial NA study, sponsored by Massachusetts General Hospital.
NCT01274585 is a NA study that was terminated before completion, run by Massachusetts General Hospital. The registered enrollment target is 5 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01274585, a NA study, was terminated before completion, sponsored by Massachusetts General Hospital.
- TERMINATED
- Registry status
- NA
- Development phase
- 5 participants
- Enrollment target
Study Summary
The primary objective of this study is to determine whether Percutaneous Tibial Nerve Stimulation (PTNS), a minimally invasive, simple, cost effective, and outpatient treatment of patients with urinary incontinence, can also be used to treat fecal incontinence. Specifically, the primary endpoint of this study is to determine, in a randomized controlled patient blinded study, whether PTNS decrease the episodes of fecal incontinence by 50% in the patients treated with PTNS when compared to placebo as documented by a 2 week patient bowel diary after treatment. The investigators secondary endpoints will consist of measurements of the impact of PTNS on the severity of incontinence (defined as a decrease in the mean Fecal Incontinence Severity Index (FISI) score ), as well as on the patient quality of life factors related to fecal incontinence (defined as a decrease in the mean Fecal Incontinence Quality of Life (FIQoL) scale).
Primary Outcome
Patient kept 2 week bowel diary after completion of treatment. Bowel diary were collected to assess frequency of fecal incontinence in the two week span.
Interventions
- DEVICE Posterior tibial nerve stimulation (PTNS)
- DEVICE Posterior tibial nerve stimulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2011-01 |
| Est. Completion | 2013-10 |
| Phase | NA |
Why NCT01274585 stopped before completion
NCT01274585 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 2 interventions - of which Posterior tibial nerve stimulation (PTNS) is the first listed.
NCT01274585 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01274585 about?
NCT01274585 is a clinical study titled "Does Percutaneous Tibial Nerve Stimulation (PTNS) Improve Outcomes in Patients Presenting With Fecal Incontinence". The primary objective of this study is to determine whether Percutaneous Tibial Nerve Stimulation (PTNS), a minimally invasive, simple, cost effective, and outpatient treatment of patients with urinary incontinence, can also be used to treat fecal incontinence. Specifically, the primary endpoint of ...
What is the current status of trial NCT01274585?
This trial is currently terminated. It is a NA study. The enrollment target is 5 participants. The study started on 2011-01. Estimated completion is 2013-10.
What interventions are being tested in trial NCT01274585?
The interventions under investigation include: Posterior tibial nerve stimulation (PTNS) (DEVICE), Posterior tibial nerve stimulation (DEVICE).
Who is sponsoring clinical trial NCT01274585?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01274585's enrollment target sits among peer trials
5 1988th of 2000 higher than 5 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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