N/A
Completed N=101
Long Term Efficacy of Sacral Nerve Modulation (SNM) in Patients With Constipation or Stool Incontinence
Source: ClinicalTrials.gov NCT02836717 ↗Enrolled (actual)
101
Serious AEs
48.1%
Results posted
Sep 2023
Primary outcomePrimary: Percentage of Patients Considering the Treatment a Success After 5 Years — 81.7; 87.3; 31.2; 91.7 percentage of success
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.
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 | — |
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
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. Informational only — not medical advice.