An interventional study of Posterior tibial nerve stimulation (PTNS) and Posterior tibial nerve stimulation in Fecal Incontinence, sponsored by Massachusetts General Hospital. Terminated at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-05.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Treatment
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).
312 studies on the registry are indexed under Fecal Incontinence; 57 are open to participants now.
This study's enrollment of 5 is below the median of 50 across 216 interventional studies indexed under Fecal Incontinence.
Browse Fecal Incontinence studies →Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: Posterior tibial nerve stimulation
Device: Posterior tibial nerve stimulation (PTNS)
Stimulation using PTNS device for 30 minutes weekly for 12 weeks
Also known as: Urgent PC
Sham needle placement without active PTNS device for 30 minutes weekly for 12 weeks
Frequency of Fecal Incontinence
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.
Time frame: Diary kept for 14 days following treatment
Change in Fecal Incontinence Severity Index (FISI) Score
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.
Time frame: 12 weeks
Change in Fecal Incontinence Quality of Life (FIQoL) Score
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.
Time frame: 12 weeks
| Milestone | No Active Treatment | Stimulation/Treatment |
|---|---|---|
| Started | 2 | 3 |
| Completed | 2 | 3 |
| Not completed | 0 | 0 |
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.
| number of accidents | No Active Treatment | Stimulation/Treatment |
|---|---|---|
| Frequency of Fecal Incontinence | 7.5 (2 to 13) | 33 (3 to 77) |
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.
| mean score | No Active Treatment | Stimulation/Treatment |
|---|---|---|
| Change in Fecal Incontinence Severity Index (FISI) Score | 6 (5 to 7) | .5 (0 to 1) |
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.
| mean score | No Active Treatment | Stimulation/Treatment |
|---|---|---|
| Change in Fecal Incontinence Quality of Life (FIQoL) Score | 11.5 (7 to 16) | 6.5 (2 to 11) |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| No Active Treatment | — | 0/2 (0%) | 2/2 (100%) |
| Stimulation/Treatment | — | 0/3 (0%) | 2/3 (66.7%) |
| Event | No Active Treatment | Stimulation/Treatment |
|---|---|---|
| pain at needle siteSkin and subcutaneous tissue disorders | 1/2 | 2/3 |
| GI bugGastrointestinal disorders | 0/2 | 2/3 |
| hematoma at needle siteSkin and subcutaneous tissue disorders | 1/2 | 0/3 |
| tingling in lower backMusculoskeletal and connective tissue disorders | 1/2 | 0/3 |
| abdominal crampingGastrointestinal disorders | 1/2 | 0/3 |
| numbnessMusculoskeletal and connective tissue disorders | 0/2 | 1/3 |
| Age, Continuous(years) | No Active Treatment | Stimulation/Treatment | Total |
|---|---|---|---|
| Mean | 50 (33 to 66) | 69 (63 to 74) | 61 (33 to 74) |
| Age, Categorical(Participants) | No Active Treatment | Stimulation/Treatment | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 1 | 1 | 2 |
| >=65 years | 1 | 2 | 3 |
| Sex: Female, Male(Participants) | No Active Treatment | Stimulation/Treatment | Total |
|---|---|---|---|
| Female | 2 | 3 | 5 |
| Male | 0 | 0 | 0 |
| Region of Enrollment(participants) | No Active Treatment | Stimulation/Treatment | Total |
|---|---|---|---|
| United States | 2 | 3 | 5 |
This study is terminated, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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Massachusetts General Hospital