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OpenTrials
Completed

NCT Number: NCT02836717

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

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.

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Key information

Conditions

Constipation Digestive System Diseases Fecal Incontinence Gastrointestinal Diseases Intestinal Diseases Pathological Conditions, Signs and Symptoms Rectal Diseases Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sacral nerve modulation

Device

electric stimulation of the sacral nerve using an implanted electrode and stimulator

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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. 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/).

  4. 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/).

  5. 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/).

  6. 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)

Sponsors and collaborators

Lead sponsor

Cantonal Hospital of St. Gallen

Other

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jul 19, 2016
Registry last updated
Sep 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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