Trial Outcomes & Findings for Long Term Efficacy of Sacral Nerve Modulation (SNM) in Patients With Constipation or Stool Incontinence (NCT NCT02836717)
NCT ID: NCT02836717
Last Updated: 2023-09-18
Results Overview
Treatment is considered a success if a patients reports a subjective 50% reduction in disease related complaints
Recruitment status
COMPLETED
Target enrollment
101 participants
Primary outcome timeframe
5 years
Results posted on
2023-09-18
Participant Flow
Participant milestones
| Measure |
FI Group
Patients suffering from fecal incontinence (only).
|
Con Group
Patients suffering from fecal constipation (only).
|
FI+Con Group
Patients suffering from fecal incontinence and constipation.
|
|---|---|---|---|
|
Test Phase
STARTED
|
73
|
16
|
12
|
|
Test Phase
COMPLETED
|
59
|
8
|
12
|
|
Test Phase
NOT COMPLETED
|
14
|
8
|
0
|
|
Study Phase
STARTED
|
59
|
8
|
12
|
|
Study Phase
COMPLETED
|
45
|
1
|
11
|
|
Study Phase
NOT COMPLETED
|
14
|
7
|
1
|
Reasons for withdrawal
| Measure |
FI Group
Patients suffering from fecal incontinence (only).
|
Con Group
Patients suffering from fecal constipation (only).
|
FI+Con Group
Patients suffering from fecal incontinence and constipation.
|
|---|---|---|---|
|
Test Phase
Lack of Efficacy
|
14
|
8
|
0
|
|
Study Phase
Adverse Event
|
2
|
0
|
0
|
|
Study Phase
Lack of Efficacy
|
8
|
6
|
1
|
|
Study Phase
Withdrawal by Subject
|
1
|
0
|
0
|
|
Study Phase
Death
|
1
|
0
|
0
|
|
Study Phase
abdominal surgeries
|
2
|
1
|
0
|
Baseline Characteristics
Long Term Efficacy of Sacral Nerve Modulation (SNM) in Patients With Constipation or Stool Incontinence
Baseline characteristics by cohort
| Measure |
FI Group
n=73 Participants
Patients suffering from fecal incontinence (only).
|
Con Group
n=16 Participants
Patients suffering from fecal constipation (only).
|
FI+Con Group
n=12 Participants
Patients suffering from fecal incontinence and constipation.
|
Total
n=101 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
71 years
n=5 Participants
|
72 years
n=7 Participants
|
70 years
n=5 Participants
|
72 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
82 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Region of Enrollment
Switzerland
|
73 participants
n=5 Participants
|
16 participants
n=7 Participants
|
12 participants
n=5 Participants
|
101 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: Rate of successfully treated patients based on time-to-event ("Kaplan-Meier") statistic
Treatment is considered a success if a patients reports a subjective 50% reduction in disease related complaints
Outcome measures
| Measure |
All Patients
n=79 Participants
All patients in study
|
FI Group
n=59 Participants
Patients suffering from fecal incontinence (only).
|
Con Group
n=8 Participants
Patients suffering from fecal constipation (only).
|
FI+Con Group
n=12 Participants
Patients suffering from fecal incontinence and constipation.
|
|---|---|---|---|---|
|
Percentage of Patients Considering the Treatment a Success After 5 Years
|
81.7 percentage of success
Interval 72.6 to 91.9
|
87.3 percentage of success
Interval 78.1 to 97.6
|
31.2 percentage of success
Interval 10.2 to 95.5
|
91.7 percentage of success
Interval 77.3 to 100.0
|
SECONDARY outcome
Timeframe: 1 yearTreatment is considered a success if a patient reports a subjective 50% reduction in disease related complaints
Outcome measures
| Measure |
All Patients
n=79 Participants
All patients in study
|
FI Group
n=59 Participants
Patients suffering from fecal incontinence (only).
|
Con Group
n=8 Participants
Patients suffering from fecal constipation (only).
|
FI+Con Group
n=12 Participants
Patients suffering from fecal incontinence and constipation.
|
|---|---|---|---|---|
|
Percentage of Patients Considering the Treatment a Success After 1 Years
|
96.0 percentage of success
Interval 91.7 to 100.0
|
98.2 percentage of success
Interval 94.7 to 100.0
|
87.5 percentage of success
Interval 67.3 to 100.0
|
91.7 percentage of success
Interval 77.3 to 100.0
|
SECONDARY outcome
Timeframe: 3 yearTreatment is considered a success if a patient reports a subjective 50% reduction in disease related complaints
Outcome measures
| Measure |
All Patients
n=79 Participants
All patients in study
|
FI Group
n=59 Participants
Patients suffering from fecal incontinence (only).
|
Con Group
n=8 Participants
Patients suffering from fecal constipation (only).
|
FI+Con Group
n=12 Participants
Patients suffering from fecal incontinence and constipation.
|
|---|---|---|---|---|
|
Percentage of Patients Considering the Treatment a Success After 3 Years
|
87.5 percentage of success
Interval 80.2 to 95.5
|
90.3 percentage of success
Interval 82.6 to 98.8
|
62.5 percentage of success
Interval 36.5 to 100.0
|
91.7 percentage of success
Interval 77.3 to 100.0
|
SECONDARY outcome
Timeframe: 1 yearpatients at risk according time-to-event statistics, i.e. number of participants still under evaluation, i.e. all participants minus the ones who have died, dropped out, or move out at the time of evaluation (https://en.wikipedia.org/wiki/Kaplan%E2%80%93Meier\_estimator, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3059453/).
Outcome measures
| Measure |
All Patients
n=79 Participants
All patients in study
|
FI Group
n=59 Participants
Patients suffering from fecal incontinence (only).
|
Con Group
n=8 Participants
Patients suffering from fecal constipation (only).
|
FI+Con Group
n=12 Participants
Patients suffering from fecal incontinence and constipation.
|
|---|---|---|---|---|
|
Number of Patients at Risk After 1 Year
|
71 participants
|
54 participants
|
7 participants
|
10 participants
|
SECONDARY outcome
Timeframe: 3 yearpatients at risk according time-to-event statistics, i.e. number of participants still under evaluation, i.e. all participants minus the ones who have died, dropped out, or move out at the time of evaluation (https://en.wikipedia.org/wiki/Kaplan%E2%80%93Meier\_estimator, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3059453/).
Outcome measures
| Measure |
All Patients
n=79 Participants
All patients in study
|
FI Group
n=59 Participants
Patients suffering from fecal incontinence (only).
|
Con Group
n=8 Participants
Patients suffering from fecal constipation (only).
|
FI+Con Group
n=12 Participants
Patients suffering from fecal incontinence and constipation.
|
|---|---|---|---|---|
|
Number of Patients at Risk After 3 Years
|
53 participants
|
39 participants
|
5 participants
|
9 participants
|
SECONDARY outcome
Timeframe: 5 yearpatients at risk according time-to-event statistics, i.e. number of participants still under evaluation, i.e. all participants minus the ones who have died, dropped out, or move out at the time of evaluation (https://en.wikipedia.org/wiki/Kaplan%E2%80%93Meier\_estimator, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3059453/).
Outcome measures
| Measure |
All Patients
n=79 Participants
All patients in study
|
FI Group
n=59 Participants
Patients suffering from fecal incontinence (only).
|
Con Group
n=8 Participants
Patients suffering from fecal constipation (only).
|
FI+Con Group
n=12 Participants
Patients suffering from fecal incontinence and constipation.
|
|---|---|---|---|---|
|
Number of Patients at Risk After 5 Years
|
37 participants
|
28 participants
|
1 participants
|
8 participants
|
SECONDARY outcome
Timeframe: 1 monthRate of patients who finished the test phase with an external stimulator successfully (subjective reporting and 50% reduction of Wexner score for incontinence)
Outcome measures
| Measure |
All Patients
n=101 Participants
All patients in study
|
FI Group
n=73 Participants
Patients suffering from fecal incontinence (only).
|
Con Group
n=16 Participants
Patients suffering from fecal constipation (only).
|
FI+Con Group
n=12 Participants
Patients suffering from fecal incontinence and constipation.
|
|---|---|---|---|---|
|
Rate of Permanent Stimulator Implantations
|
79 Participants
|
59 Participants
|
8 Participants
|
12 Participants
|
Adverse Events
FI Group
Serious events: 28 serious events
Other events: 11 other events
Deaths: 1 deaths
Con Group
Serious events: 6 serious events
Other events: 1 other events
Deaths: 0 deaths
FI+Con Group
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
FI Group
n=59 participants at risk
Patients suffering from fecal incontinence (only).
|
Con Group
n=8 participants at risk
Patients suffering from fecal constipation (only).
|
FI+Con Group
n=12 participants at risk
Patients suffering from fecal incontinence and constipation.
|
|---|---|---|---|
|
Product Issues
Other: Broken or dislocated lead
|
23.7%
14/59 • Number of events 19 • 5 years
|
37.5%
3/8 • Number of events 3 • 5 years
|
33.3%
4/12 • Number of events 5 • 5 years
|
|
Infections and infestations
Device related infection
|
8.5%
5/59 • Number of events 6 • 5 years
|
12.5%
1/8 • Number of events 1 • 5 years
|
16.7%
2/12 • Number of events 2 • 5 years
|
|
General disorders
Pain
|
11.9%
7/59 • Number of events 8 • 5 years
|
25.0%
2/8 • Number of events 3 • 5 years
|
0.00%
0/12 • 5 years
|
|
Product Issues
Other: Pulse generator dislocation
|
8.5%
5/59 • Number of events 5 • 5 years
|
0.00%
0/8 • 5 years
|
8.3%
1/12 • Number of events 1 • 5 years
|
|
Product Issues
Other: Device failure
|
8.5%
5/59 • Number of events 5 • 5 years
|
12.5%
1/8 • Number of events 1 • 5 years
|
0.00%
0/12 • 5 years
|
Other adverse events
| Measure |
FI Group
n=59 participants at risk
Patients suffering from fecal incontinence (only).
|
Con Group
n=8 participants at risk
Patients suffering from fecal constipation (only).
|
FI+Con Group
n=12 participants at risk
Patients suffering from fecal incontinence and constipation.
|
|---|---|---|---|
|
Product Issues
Other: Dislocated lead
|
5.1%
3/59 • Number of events 3 • 5 years
|
0.00%
0/8 • 5 years
|
0.00%
0/12 • 5 years
|
|
Infections and infestations
Device related infection
|
8.5%
5/59 • Number of events 5 • 5 years
|
0.00%
0/8 • 5 years
|
0.00%
0/12 • 5 years
|
|
General disorders
Pain
|
1.7%
1/59 • Number of events 1 • 5 years
|
12.5%
1/8 • Number of events 1 • 5 years
|
0.00%
0/12 • 5 years
|
|
Product Issues
Other
|
3.4%
2/59 • Number of events 2 • 5 years
|
0.00%
0/8 • 5 years
|
0.00%
0/12 • 5 years
|
Additional Information
Dr Lukas Marti
Department of Surgery, Cantonal Hospital St. Gallen
Phone: +41 71 494 11 11
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place