Trial Outcomes & Findings for Does Percutaneous Tibial Nerve Stimulation (PTNS) Improve Outcomes in Patients Presenting With Fecal Incontinence (NCT NCT01274585)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

5 participants

Primary outcome timeframe

Diary kept for 14 days following treatment

Results posted on

2018-01-05

Participant Flow

Participant milestones

Participant milestones
Measure	No Active Treatment Posterior tibial nerve stimulation: Sham needle placement without active PTNS device for 30 minutes weekly for 12 weeks	Stimulation/Treatment Posterior tibial nerve stimulation (PTNS): Stimulation using PTNS device for 30 minutes weekly for 12 weeks
Overall Study STARTED	2	3
Overall Study COMPLETED	2	3
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Does Percutaneous Tibial Nerve Stimulation (PTNS) Improve Outcomes in Patients Presenting With Fecal Incontinence

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	No Active Treatment n=2 Participants Posterior tibial nerve stimulation: Sham needle placement without active PTNS device for 30 minutes weekly for 12 weeks	Stimulation/Treatment n=3 Participants Posterior tibial nerve stimulation (PTNS): Stimulation using PTNS device for 30 minutes weekly for 12 weeks	Total n=5 Participants Total of all reporting groups
Age, Continuous	50 years n=93 Participants	69 years n=4 Participants	61 years n=27 Participants
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Age, Categorical >=65 years	1 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants
Sex: Female, Male Female	2 Participants n=93 Participants	3 Participants n=4 Participants	5 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	2 participants n=93 Participants	3 participants n=4 Participants	5 participants n=27 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	No Active Treatment n=2 Participants Posterior tibial nerve stimulation: Sham needle placement without active PTNS device for 30 minutes weekly for 12 weeks	Stimulation/Treatment n=3 Participants Posterior tibial nerve stimulation (PTNS): Stimulation using PTNS device for 30 minutes weekly for 12 weeks
Frequency of Fecal Incontinence	7.5 number of accidents Interval 2.0 to 13.0	33 number of accidents Interval 3.0 to 77.0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	No Active Treatment n=2 Participants Posterior tibial nerve stimulation: Sham needle placement without active PTNS device for 30 minutes weekly for 12 weeks	Stimulation/Treatment n=2 Participants Posterior tibial nerve stimulation (PTNS): Stimulation using PTNS device for 30 minutes weekly for 12 weeks
Change in Fecal Incontinence Severity Index (FISI) Score	6 mean score Interval 5.0 to 7.0	.5 mean score Interval 0.0 to 1.0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	No Active Treatment n=2 Participants Posterior tibial nerve stimulation: Sham needle placement without active PTNS device for 30 minutes weekly for 12 weeks	Stimulation/Treatment n=2 Participants Posterior tibial nerve stimulation (PTNS): Stimulation using PTNS device for 30 minutes weekly for 12 weeks
Change in Fecal Incontinence Quality of Life (FIQoL) Score	11.5 mean score Interval 7.0 to 16.0	6.5 mean score Interval 2.0 to 11.0

Adverse Events

No Active Treatment

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Stimulation/Treatment

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	No Active Treatment n=2 participants at risk Posterior tibial nerve stimulation: Sham needle placement without active PTNS device for 30 minutes weekly for 12 weeks	Stimulation/Treatment n=3 participants at risk Posterior tibial nerve stimulation (PTNS): Stimulation using PTNS device for 30 minutes weekly for 12 weeks
Skin and subcutaneous tissue disorders pain at needle site	50.0% 1/2 • Number of events 1	66.7% 2/3 • Number of events 2
Skin and subcutaneous tissue disorders hematoma at needle site	50.0% 1/2 • Number of events 1	0.00% 0/3
Musculoskeletal and connective tissue disorders tingling in lower back	50.0% 1/2 • Number of events 1	0.00% 0/3
Gastrointestinal disorders abdominal cramping	50.0% 1/2 • Number of events 1	0.00% 0/3
Musculoskeletal and connective tissue disorders numbness	0.00% 0/2	33.3% 1/3 • Number of events 1
Gastrointestinal disorders GI bug	0.00% 0/2	66.7% 2/3 • Number of events 2

Additional Information

Does Percutaneous Tibial Nerve Stimulation (PTNS) Improve Outcomes in Patients

Massachusetts General Hospital

Phone: 617-643-0541

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place