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

Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02836717
• Other study ID #: SGChir201601
• Status: Completed
• Start date: April 2016
• Est. completion date: September 2016

Study information

• Verified date: November 2022
• Source: Cantonal Hospital of St. Gallen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Constipation
• Fecal Incontinence

Intervention

Device:
• sacral nerve modulation
electric stimulation of the sacral nerve using an implanted electrode and stimulator

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cantonal Hospital of St. Gallen

References & Publications (1)

Widmann B, Galata C, Warschkow R, Beutner U, Ogredici O, Hetzer FH, Schmied BM, Post S, Marti L. Success and Complication Rates After Sacral Neuromodulation for Fecal Incontinence and Constipation: A Single-center Follow-up Study. J Neurogastroenterol Mot — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	5 years
Secondary	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	1 year
Secondary	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	3 year
Secondary	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/).	1 year
Secondary	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/).	3 year
Secondary	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/).	5 year
Secondary	Rate of Permanent Stimulator Implantations	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