- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02836717
Long Term Efficacy of Sacral Nerve Modulation (SNM) in Patients With Constipation or Stool Incontinence
November 15, 2022 updated by: Lukas Marti, Cantonal Hospital of St. Gallen
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
101
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
patients starting an SNM treatment for constipation or fecal incontinence between March 2006 and October 2015
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Patients Considering the Treatment a Success After 5 Years
Time Frame: 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
Time Frame: 1 year
|
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
Time Frame: 3 year
|
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
Time Frame: 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
Time Frame: 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/).
|
3 year
|
Number of Patients at Risk After 5 Years
Time Frame: 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/).
|
5 year
|
Rate of Permanent Stimulator Implantations
Time Frame: 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)
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lukas Marti, MD, Cantonal Hospital St. Gallen
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2016
Primary Completion (Actual)
September 1, 2016
Study Completion (Actual)
September 1, 2016
Study Registration Dates
First Submitted
June 22, 2016
First Submitted That Met QC Criteria
July 14, 2016
First Posted (Estimated)
July 19, 2016
Study Record Updates
Last Update Posted (Actual)
September 18, 2023
Last Update Submitted That Met QC Criteria
November 15, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SGChir201601
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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