N/A N=101

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

Constipation · Fecal Incontinence

Bottom Line

View on ClinicalTrials.gov: NCT02836717 ↗

Enrolled (actual)

101

Serious AEs

48.1%

Results posted

Sep 2023

Primary outcome: Primary: Percentage of Patients Considering the Treatment a Success After 5 Years — 81.7; 87.3; 31.2; 91.7 percentage of success

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: sacral nerve modulation (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Cantonal Hospital of St. Gallen
Primary completion: Sep 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Patients Considering the Treatment a Success After 5 Years	81.7; 87.3; 31.2; 91.7	—
SECONDARY Percentage of Patients Considering the Treatment a Success After 1 Years	96.0; 98.2; 87.5; 91.7	—
SECONDARY Percentage of Patients Considering the Treatment a Success After 3 Years	87.5; 90.3; 62.5; 91.7	—
SECONDARY Number of Patients at Risk After 1 Year	71; 54; 7; 10	—
SECONDARY Number of Patients at Risk After 3 Years	53; 39; 5; 9	—
SECONDARY Number of Patients at Risk After 5 Years	37; 28; 1; 8	—
SECONDARY Rate of Permanent Stimulator Implantations	79; 59; 8; 12	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02836717). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.