Constipation, Fecal Incontinence
Conditions
Keywords
sacral nerve modulation, quality of life, stimulator maintenance, SNM
Brief summary
The aim of this study is to determine the success rate, the success duration, the complication rate, maintenance effort and quality of life several years after sacral nerve modulation (SNM) treatment for constipation or stool incontinence.
Interventions
DEVICEsacral nerve modulation
electric stimulation of the sacral nerve using an implanted electrode and stimulator
Sponsors
Cantonal Hospital of St. Gallen
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who had received an SNM treatment in the last 10 years
Exclusion criteria
* pudendal nerve stimulation * refusal to allow use of clinical data for retrospective data analysis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients Considering the Treatment a Success After 5 Years | 5 years | Treatment is considered a success if a patients reports a subjective 50% reduction in disease related complaints |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients Considering the Treatment a Success After 3 Years | 3 year | Treatment is considered a success if a patient reports a subjective 50% reduction in disease related complaints |
| Number of Patients at Risk After 1 Year | 1 year | patients 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/). |
| Percentage of Patients Considering the Treatment a Success After 1 Years | 1 year | Treatment is considered a success if a patient reports a subjective 50% reduction in disease related complaints |
| Number of Patients at Risk After 5 Years | 5 year | patients 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/). |
| Rate of Permanent Stimulator Implantations | 1 month | Rate of patients who finished the test phase with an external stimulator successfully (subjective reporting and 50% reduction of Wexner score for incontinence) |
| Number of Patients at Risk After 3 Years | 3 year | patients 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/). |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| FI Group Patients suffering from fecal incontinence (only). | 73 |
| Con Group Patients suffering from fecal constipation (only). | 16 |
| FI+Con Group Patients suffering from fecal incontinence and constipation. | 12 |
| Total | 101 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Study Phase | abdominal surgeries | 2 | 1 | 0 |
| Study Phase | Adverse Event | 2 | 0 | 0 |
| Study Phase | Death | 1 | 0 | 0 |
| Study Phase | Lack of Efficacy | 8 | 6 | 1 |
| Study Phase | Withdrawal by Subject | 1 | 0 | 0 |
| Test Phase | Lack of Efficacy | 14 | 8 | 0 |
Baseline characteristics
| Characteristic | FI Group | Con Group | FI+Con Group | Total |
|---|---|---|---|---|
| Age, Continuous | 71 years | 72 years | 70 years | 72 years |
| Region of Enrollment Switzerland | 73 participants | 16 participants | 12 participants | 101 participants |
| Sex: Female, Male Female | 60 Participants | 11 Participants | 11 Participants | 82 Participants |
| Sex: Female, Male Male | 13 Participants | 5 Participants | 1 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 59 | 0 / 8 | 0 / 12 |
| other Total, other adverse events | 11 / 59 | 1 / 8 | 0 / 12 |
| serious Total, serious adverse events | 28 / 59 | 6 / 8 | 4 / 12 |
Outcome results
Primary
Percentage of Patients Considering the Treatment a Success After 5 Years
Treatment is considered a success if a patients reports a subjective 50% reduction in disease related complaints
Time frame: 5 years
Population: Rate of successfully treated patients based on time-to-event (Kaplan-Meier) statistic
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Patients | Percentage of Patients Considering the Treatment a Success After 5 Years | 81.7 percentage of success |
| FI Group | Percentage of Patients Considering the Treatment a Success After 5 Years | 87.3 percentage of success |
| Con Group | Percentage of Patients Considering the Treatment a Success After 5 Years | 31.2 percentage of success |
| FI+Con Group | Percentage of Patients Considering the Treatment a Success After 5 Years | 91.7 percentage of success |
Secondary
Number of Patients at Risk After 1 Year
patients 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/).
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Patients | Number of Patients at Risk After 1 Year | 71 participants |
| FI Group | Number of Patients at Risk After 1 Year | 54 participants |
| Con Group | Number of Patients at Risk After 1 Year | 7 participants |
| FI+Con Group | Number of Patients at Risk After 1 Year | 10 participants |
Secondary
Number of Patients at Risk After 3 Years
patients 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/).
Time frame: 3 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Patients | Number of Patients at Risk After 3 Years | 53 participants |
| FI Group | Number of Patients at Risk After 3 Years | 39 participants |
| Con Group | Number of Patients at Risk After 3 Years | 5 participants |
| FI+Con Group | Number of Patients at Risk After 3 Years | 9 participants |
Secondary
Number of Patients at Risk After 5 Years
patients 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/).
Time frame: 5 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Patients | Number of Patients at Risk After 5 Years | 37 participants |
| FI Group | Number of Patients at Risk After 5 Years | 28 participants |
| Con Group | Number of Patients at Risk After 5 Years | 1 participants |
| FI+Con Group | Number of Patients at Risk After 5 Years | 8 participants |
Secondary
Percentage of Patients Considering the Treatment a Success After 1 Years
Treatment is considered a success if a patient reports a subjective 50% reduction in disease related complaints
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Patients | Percentage of Patients Considering the Treatment a Success After 1 Years | 96.0 percentage of success |
| FI Group | Percentage of Patients Considering the Treatment a Success After 1 Years | 98.2 percentage of success |
| Con Group | Percentage of Patients Considering the Treatment a Success After 1 Years | 87.5 percentage of success |
| FI+Con Group | Percentage of Patients Considering the Treatment a Success After 1 Years | 91.7 percentage of success |
Secondary
Percentage of Patients Considering the Treatment a Success After 3 Years
Treatment is considered a success if a patient reports a subjective 50% reduction in disease related complaints
Time frame: 3 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Patients | Percentage of Patients Considering the Treatment a Success After 3 Years | 87.5 percentage of success |
| FI Group | Percentage of Patients Considering the Treatment a Success After 3 Years | 90.3 percentage of success |
| Con Group | Percentage of Patients Considering the Treatment a Success After 3 Years | 62.5 percentage of success |
| FI+Con Group | Percentage of Patients Considering the Treatment a Success After 3 Years | 91.7 percentage of success |
Secondary
Rate of Permanent Stimulator Implantations
Rate of patients who finished the test phase with an external stimulator successfully (subjective reporting and 50% reduction of Wexner score for incontinence)
Time frame: 1 month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Patients | Rate of Permanent Stimulator Implantations | 79 Participants |
| FI Group | Rate of Permanent Stimulator Implantations | 59 Participants |
| Con Group | Rate of Permanent Stimulator Implantations | 8 Participants |
| FI+Con Group | Rate of Permanent Stimulator Implantations | 12 Participants |