Long Term Efficacy of Sacral Nerve Modulation (SNM) in Patients With Constipation or Stool Incontinence

Study Overview
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Brief Summary
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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.

Official Title
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Long Term Efficacy of Sacral Nerve Modulation (SNM) in Patients With Constipation or Stool Incontinence

Conditions
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Constipation, Fecal Incontinence

Intervention / Treatment
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* Device: sacral nerve modulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: sacral nerve modulation|electric stimulation of the sacral nerve using an implanted electrode and stimulator|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1 year | 
| 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 | 3 year | 
| 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/). | 1 year | 
| 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/). | 3 year | 
| 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/). | 5 year | 
| 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) | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sacral nerve modulation, quality of life, stimulator maintenance, SNM