Long Term Efficacy of Sacral Nerve Modulation (SNM) in Patients With Constipation or Stool Incontinence
1 other identifier
observational
101
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2016
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 22, 2016
CompletedFirst Posted
Study publicly available on registry
July 19, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedResults Posted
Study results publicly available
September 18, 2023
CompletedSeptember 18, 2023
November 1, 2022
5 months
June 22, 2016
July 11, 2019
November 15, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Percentage of Patients Considering the Treatment a Success After 1 Years
1 year
Percentage of Patients Considering the Treatment a Success After 3 Years
3 year
Number of Patients at Risk After 1 Year
1 year
Number of Patients at Risk After 3 Years
3 year
Number of Patients at Risk After 5 Years
5 year
- +1 more secondary outcomes
Interventions
electric stimulation of the sacral nerve using an implanted electrode and stimulator
Eligibility Criteria
patients starting an SNM treatment for constipation or fecal incontinence between March 2006 and October 2015
You may qualify if:
- Patients who had received an SNM treatment in the last 10 years
You may not qualify if:
- pudendal nerve stimulation
- refusal to allow use of clinical data for retrospective data analysis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related 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 Motil. 2019 Jan 31;25(1):159-170. doi: 10.5056/jnm17106.
PMID: 30646487RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Observed death was unrelated to study treatment or study participation
Results Point of Contact
- Title
- Dr Lukas Marti
- Organization
- Department of Surgery, Cantonal Hospital St. Gallen
Study Officials
- PRINCIPAL INVESTIGATOR
Lukas Marti, MD
Cantonal Hospital of St. Gallen
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 22, 2016
First Posted
July 19, 2016
Study Start
April 1, 2016
Primary Completion
September 1, 2016
Study Completion
September 1, 2016
Last Updated
September 18, 2023
Results First Posted
September 18, 2023
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share