Fecal Incontinence
Conditions
Brief 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
Stimulation using PTNS device for 30 minutes weekly for 12 weeks
Sham needle placement without active PTNS device for 30 minutes weekly for 12 weeks
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 18 years or older * Able to provide informed consent * Has severe fecal incontinence (defined as weekly episodes of incontinence of mucus, liquid or solid stool) * Available to present for weekly treatments * Available for follow-up at 3, 6, and 12 months
Exclusion criteria
1. Severe cardiopulmonary disease 2. Lesion of the Tibial Nerve 3. Use of a cardiac pacemaker or implantable defibrillator 4. History of inflammatory bowel disease 5. Active anal fissure, fistula, or abscess 6. Active rectal bleeding which has not been evaluated with appropriate testing, such as colonoscopy 7. Has a sphincter injury that needs sphincteroplasty 8. Wants to pursue aggressive surgical therapy with a colostomy or an artificial bowel sphincter 9. Severe distal venous insufficiency 10. Uncontrolled diabetes with peripheral nerve involvement 11. Immunosuppression 12. Pregnant or planning on becoming pregnant during treatment 13. Patients prone to bleeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Fecal Incontinence | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fecal Incontinence Severity Index (FISI) Score | 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| No Active Treatment Posterior tibial nerve stimulation: Sham needle placement without active PTNS device for 30 minutes weekly for 12 weeks | 2 |
| Stimulation/Treatment Posterior tibial nerve stimulation (PTNS): Stimulation using PTNS device for 30 minutes weekly for 12 weeks | 3 |
| Total | 5 |
Baseline characteristics
| Characteristic | No Active Treatment | Stimulation/Treatment | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 2 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Continuous | 50 years | 69 years | 61 years |
| Region of Enrollment United States | 2 participants | 3 participants | 5 participants |
| Sex: Female, Male Female | 2 Participants | 3 Participants | 5 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 2 | 2 / 3 |
| serious Total, serious adverse events | 0 / 2 | 0 / 3 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| No Active Treatment | Frequency of Fecal Incontinence | 7.5 number of accidents |
| Stimulation/Treatment | Frequency of Fecal Incontinence | 33 number of accidents |
Secondary
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
Population: Only 4 of the 5 subjects completed questionnaires at the completion of the trial. Therefore, these were the only subjects included in analysis.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| No Active Treatment | Change in Fecal Incontinence Quality of Life (FIQoL) Score | 11.5 mean score |
| Stimulation/Treatment | Change in Fecal Incontinence Quality of Life (FIQoL) Score | 6.5 mean score |
Secondary
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
Population: Only 4 of the 5 subjects completed questionnaires at the completion of the trial. Therefore, these were the only subjects included in analysis.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| No Active Treatment | Change in Fecal Incontinence Severity Index (FISI) Score | 6 mean score |
| Stimulation/Treatment | Change in Fecal Incontinence Severity Index (FISI) Score | .5 mean score |