Does Percutaneous Tibial Nerve Stimulation (PTNS) Improve Outcomes in Patients Presenting With Fecal Incontinence
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|ClinicalTrials.gov Identifier: NCT01274585|
Recruitment Status : Terminated (Study was terminated due to low recruitment rates)
First Posted : January 11, 2011
Results First Posted : February 13, 2014
Last Update Posted : January 5, 2018
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).
|Condition or disease||Intervention/treatment||Phase|
|Fecal Incontinence||Device: Posterior tibial nerve stimulation (PTNS) Device: Posterior tibial nerve stimulation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Does Percutaneous Tibial Nerve Stimulation (PTNS) Improve Outcomes in Patients Presenting With Fecal Incontinence|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||October 2013|
|Sham Comparator: No active treatment||
Device: Posterior tibial nerve stimulation
Sham needle placement without active PTNS device for 30 minutes weekly for 12 weeks
Device: Posterior tibial nerve stimulation (PTNS)
Stimulation using PTNS device for 30 minutes weekly for 12 weeks
Other Name: Urgent PC
- Frequency of Fecal Incontinence [ Time Frame: Diary kept for 14 days following treatment ]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.
- Change in Fecal Incontinence Severity Index (FISI) Score [ Time Frame: 12 weeks ]Fecal Incontinence Severity Index (FISI) is a tool used to stratify severity of fecal incontinence in the subjects. The range of score is from 0 to 61 where the higher score correlates with more severe symptoms of incontinence.
- Change in Fecal Incontinence Quality of Life (FIQoL) Score [ Time Frame: 12 weeks ]The Fecal incontinence Quality of Life (FIQoL) score evaluates how fecal incontinence impacts the subjects quality of life. The scale ranges from 37 to 159 where the higher the score, the better the quality of life associated with symptoms.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01274585
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Liliana Bordeianou, MD||Massachusetts General Hospital|