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

Cantonal Hospital of St. Gallen0 sites101 target enrollmentApril 2016

ConditionsConstipation Fecal Incontinence

Overview

Phase: N/A
Intervention: Not specified
Conditions: Constipation
Sponsor: Cantonal Hospital of St. Gallen
Enrollment: 101
Primary Endpoint: Percentage of Patients Considering the Treatment a Success After 5 Years
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 2016

End Date

September 2016

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Cantonal Hospital of St. Gallen

Responsible Party

Principal Investigator

Lukas Marti

Principal Investigator

Cantonal Hospital of St. Gallen

Eligibility Criteria

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

Time Frame: 5 years

Treatment is considered a success if a patients reports a subjective 50% reduction in disease related complaints

Secondary Outcomes

Percentage of Patients Considering the Treatment a Success After 3 Years(3 year)
Number of Patients at Risk After 1 Year(1 year)
Percentage of Patients Considering the Treatment a Success After 1 Years(1 year)
Number of Patients at Risk After 3 Years(3 year)
Number of Patients at Risk After 5 Years(5 year)
Rate of Permanent Stimulator Implantations(1 month)