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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. 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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01274585
The ClinicalTrials.gov registry entry for NCT01274585 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Posterior tibial nerve stimulation (PTNS) is the first listed.
NCT01274585 reports 0 study locations.
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.
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