NCT02836717 - Long Term Efficacy of Sacral Nerve Modulation (SNM) in Patients With Constipation or Stool Incontinence | Crick

Overview

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 Type

OBSERVATIONAL

Enrollment

101

Conditions

Constipation Fecal Incontinence

Interventions

sacral nerve modulationDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 5 years

Secondary Outcomes

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

Time frame: 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

Time frame: 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/).

Time frame: 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/).

Time frame: 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/).