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Treatment of Faecal Incontinence With Sacral Nerve Stimulation - Improved Function With Stimulation Bilaterally? (SNS)

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ClinicalTrials.gov Identifier: NCT00913601
Recruitment Status : Terminated (Prematurely stopped, as no beneficial effect was evident for bilateral stimulation after interim analysis of the first 20 patients.)
First Posted : June 4, 2009
Last Update Posted : July 3, 2014
Sponsor:
Collaborator:
MEDTRONIC DANMARK A/S Arne Jacobsens Alle 17 DK-2300 København S Danmark
Information provided by (Responsible Party):
Jakob Jakobsen, University of Aarhus

Tracking Information
First Submitted Date  ICMJE June 2, 2009
First Posted Date  ICMJE June 4, 2009
Last Update Posted Date July 3, 2014
Study Start Date  ICMJE May 2009
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2009)
Number of faecal incontinence episodes per week. [ Time Frame: 1, 2, and 3 months after enrolment to the project ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2009)
  • Days with faecal soiling. [ Time Frame: 1, 2, and 3 months after enrolment to the project ]
  • Days with faecal urgency. [ Time Frame: 1, 2, and 3 months after enrolment to the project ]
  • Wexner incontinence score. [ Time Frame: 1, 2, and 3 months after enrolment to the project ]
  • Anal physiological changes during SNS bilateral versus unilateral. [ Time Frame: 1, 2, and 3 months after enrolment to the project ]
  • Quality of life assessment (Rockwood - Fecal incontinence quality of life) [ Time Frame: 1, 2, and 3 months after enrolment to the project ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Faecal Incontinence With Sacral Nerve Stimulation - Improved Function With Stimulation Bilaterally?
Official Title  ICMJE Treatment of Idiopathic Faecal Incontinence With Sacral Nerve Stimulation - Improved Function With Implantation and Stimulation of Permanent Electrodes Bilaterally - a Double-blinded Randomized Cross-over Trial
Brief Summary Faecal incontinence is a devastating condition causing psychological stress, affecting daily living and influences quality of life. Faecal incontinence affects 2,2 to 5 % of the adult population. The magnitude of the problem is probably underestimated, because most patients don't discuss this affliction with their general practitioner. A new treatment, sacral nerve stimulation (SNS), has over the last decade given hope to these patients. The treatment is divided in two; first a test operation (PNE-test) has to reveal if the patient will benefit from treatment with permanent sacral nerve stimulation. Second if the patient benefit from the PNE-test, they proceed to final implant. 75-80% of the patients with idiopathic fecal incontinence benefit from the PNE-test, 70% of those get satisfactory functional results and the remaining 30% get suboptimal improvement in continence after permanent unilateral sacral nerve stimulation. The aim of this project is to investigate if bilateral sacral nerve stimulation can produce better fecal continence results than standard unilateral stimulation, through a double blind, randomized crossover study.
Detailed Description

Sacral nerve stimulation is a very good and effective treatment for faecal incontinence The method was introduced to patients with voiding disorders in 1981. In 1995 sacral nerve stimulation was used for three patients with faecal incontinence, two were afterwards fully continent. The method has over the last decade been used increasingly in Europe. The method is now used routinely in the treatment of faecal incontinence in Europe.

Recent studies have shown that the effect of sacral nerve stimulation is due to a neuromodulation in the central nervous system, whereas direct stimulation of efferent nerves to anal sphincter and the pelvic floor has less significance.

The sacral nerve stimulation is performed in two steps, first a test stimulation, if positive the patients proceed to permanent implant.

Test stimulation (PNE-test) is performed over a 3 week period. If this test stimulation produces a decrease in incontinence episodes of more than 50 per cent, a permanent electrode and neurostimulator are implanted. The test period has a success rate of approximately 75-80% in patients with idiopathic fecal incontinence or incontinence after anal surgery. These 75-80% will normal be candidates to unilateral implantation of permanent electrode and neurostimulator.

All permanently implanted has less incontinence symptoms after the treatment. Satisfactory continence results after permanent implantation are seen in 70% of the patients, the remaining 30% only obtain a suboptimal efficacy. It is unclear whether these patients could have a more optimal function if they were stimulate on more than one sacral nerve simultaneously.

Hypothesis: Is it possible to improve the functional result in faecal incontinent patients treated with routine unilateral sacral nerve stimulation by stimulating the sacral nerves bilaterally.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Fecal Incontinence
Intervention  ICMJE Device: Medtronic INTERSIM II - 3058
Medtronic INTERSIM II - 3058 Impuls Generator
Other Name: Impuls Generator
Study Arms  ICMJE
  • Experimental: Dextra
    Unilateral sacral nerve stimulation dextra for 4 weeks
    Intervention: Device: Medtronic INTERSIM II - 3058
  • Experimental: Sinistra
    Unilateral sacral nerve stimulation sinistra 4 weeks
    Intervention: Device: Medtronic INTERSIM II - 3058
  • Experimental: Bilateral
    Bilateral sacral nerve stimulation 4 weeks
    Intervention: Device: Medtronic INTERSIM II - 3058
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 2, 2014)
29
Original Estimated Enrollment  ICMJE
 (submitted: June 3, 2009)
50
Actual Study Completion Date  ICMJE July 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Informed Consent
  • Diagnosed with idiopathic faecal incontinence and planned sacral nerve stimulation
  • Age> 40 years normal sigmoid/colonoscopic prior to operation

Exclusion Criteria:

  • Pregnant or breastfeeding
  • Patients who are not deemed able to follow the planned testing program, including mental illness or mentally unstable patients
  • Medication with known effects on gastrointestinal motility, thyroid disease, diabetes, coeliaki, neurological disorders.
  • Irritable Bowel Syndrome
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00913601
Other Study ID Numbers  ICMJE 001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jakob Jakobsen, University of Aarhus
Study Sponsor  ICMJE University of Aarhus
Collaborators  ICMJE MEDTRONIC DANMARK A/S Arne Jacobsens Alle 17 DK-2300 København S Danmark
Investigators  ICMJE
Principal Investigator: Jakob K Jakobsen, MD Anal Physiology Laboratory, Surgical Research Section 900, Aarhus University Hospital, Denmark
PRS Account University of Aarhus
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP