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

Completed

• Conditions: Fecal Incontinence; Constipation

• Registration Number: NCT02836717
• Lead Sponsor: Cantonal Hospital of St. Gallen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-06-22
• Study First Submitted QC: 2016-07-14
• Study First Posted: 2016-07-19
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Results First Submitted: 2019-07-11
• Status Verified: 2022-11
• Results First Submitted QC: 2022-11-15
• Last Update Submitted: 2022-11-15
• Results First Posted: 2023-09-18
• Last Update Posted: 2023-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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/).
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)