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

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ClinicalTrials.gov Identifier: NCT02836717
Recruitment Status : Completed
First Posted : July 19, 2016
Last Update Posted : January 31, 2017
Sponsor:
Information provided by (Responsible Party):
Lukas Marti, Cantonal Hospital of St. Gallen

Study Description
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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.

Condition or disease Intervention/treatment
Constipation Fecal Incontinence Device: sacral nerve modulation

Study Design
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Study Type : Observational
Actual Enrollment : 101 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Long Term Efficacy of Sacral Nerve Modulation (SNM) in Patients With Constipation or Stool Incontinence
Actual Study Start Date : April 2016
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

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

Outcome Measures
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Primary Outcome Measures :
  1. subjective complaint reduction [ Time Frame: 10 years ]
    Treatment is considered a success if patients report a subjective 50% reduction in disease related complaints


Secondary Outcome Measures :
  1. Rate of permanent stimulator implantations [ Time Frame: 1 month ]
    Rate of patients who finish the test phase with an external stimulator successfully (subjective reporting and 50% reduction of Wexner score for incontinence

  2. Complication rate [ Time Frame: 10 years ]
    rate of treatment related complications

  3. Rate of reoperations [ Time Frame: 10 years ]
    rate of reoperations necessary due to the treatment (e.g. electrode dislocation, electrode breakage)

  4. maintenance cost [ Time Frame: 10 years ]
    Cost incurred to maintain the treatment (e.g. relocation of electrodes, replacement of stimulator due to failure or low battery)

  5. Fecal incontinence quality of life (FIQL) [ Time Frame: 10 years ]
    Rockwood's FIQL scale

  6. Wexner Score [ Time Frame: 10 years ]
    Wexner score for fecal incontinence


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients starting an SNM treatment for constipation or fecal incontinence between March 2006 and October 2015
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02836717


Sponsors and Collaborators
Cantonal Hospital of St. Gallen
Investigators
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Principal Investigator: Lukas Marti, MD Cantonal Hospital St. Gallen
More Information
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Responsible Party: Lukas Marti, Principal Investigator, Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier: NCT02836717    
Other Study ID Numbers: SGChir201601
First Posted: July 19, 2016    Key Record Dates
Last Update Posted: January 31, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Lukas Marti, Cantonal Hospital of St. Gallen:
sacral nerve modulation
quality of life
stimulator maintenance
SNM
Additional relevant MeSH terms:
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Fecal Incontinence
Constipation
Signs and Symptoms, Digestive
Rectal Diseases
 Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases