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

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.

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

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.

Clinical Trials on Constipation

Clinical Trials on sacral nerve modulation

3
Subscribe