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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

Tracking Information
First Submitted Date June 22, 2016
First Posted Date July 19, 2016
Last Update Posted Date January 31, 2017
Actual Study Start Date April 2016
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 14, 2016)		 subjective complaint reduction [ Time Frame: 10 years ]
Treatment is considered a success if patients report a subjective 50% reduction in disease related complaints
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 14, 2016)
  • 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
  • Complication rate [ Time Frame: 10 years ]
    rate of treatment related complications
  • Rate of reoperations [ Time Frame: 10 years ]
    rate of reoperations necessary due to the treatment (e.g. electrode dislocation, electrode breakage)
  • 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)
  • Fecal incontinence quality of life (FIQL) [ Time Frame: 10 years ]
    Rockwood's FIQL scale
  • Wexner Score [ Time Frame: 10 years ]
    Wexner score for fecal incontinence
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Long Term Efficacy of Sacral Nerve Modulation (SNM) in Patients With Constipation or Stool Incontinence
Official Title Long Term Efficacy of Sacral Nerve Modulation (SNM) in Patients With Constipation or Stool Incontinence
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population patients starting an SNM treatment for constipation or fecal incontinence between March 2006 and October 2015
Condition
  • Constipation
  • Fecal Incontinence
Intervention Device: sacral nerve modulation
electric stimulation of the sacral nerve using an implanted electrode and stimulator
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 30, 2017)		 101
Original Estimated Enrollment
 (submitted: July 14, 2016)		 117
Actual Study Completion Date September 2016
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02836717
Other Study ID Numbers SGChir201601
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Lukas Marti, Cantonal Hospital of St. Gallen
Study Sponsor Cantonal Hospital of St. Gallen
Collaborators Not Provided
Investigators
Principal Investigator: Lukas Marti, MD Cantonal Hospital St. Gallen
PRS Account Cantonal Hospital of St. Gallen
Verification Date January 2017