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

This study has been terminated.
(Prematurely stopped, as no beneficial effect was evident for bilateral stimulation after interim analysis of the first 20 patients.)
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
ClinicalTrials.gov Identifier:
NCT00913601
First received: June 2, 2009
Last updated: July 2, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Fecal Incontinence
Device: Medtronic INTERSIM II - 3058

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Number of faecal incontinence episodes per week. [ Time Frame: 1, 2, and 3 months after enrolment to the project ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Days with faecal soiling. [ Time Frame: 1, 2, and 3 months after enrolment to the project ] [ Designated as safety issue: No ]
  • Days with faecal urgency. [ Time Frame: 1, 2, and 3 months after enrolment to the project ] [ Designated as safety issue: No ]
  • Wexner incontinence score. [ Time Frame: 1, 2, and 3 months after enrolment to the project ] [ Designated as safety issue: No ]
  • Anal physiological changes during SNS bilateral versus unilateral. [ Time Frame: 1, 2, and 3 months after enrolment to the project ] [ Designated as safety issue: No ]
  • Quality of life assessment (Rockwood - Fecal incontinence quality of life) [ Time Frame: 1, 2, and 3 months after enrolment to the project ] [ Designated as safety issue: No ]

Enrollment: 29
Study Start Date: May 2009
Study Completion Date: July 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dextra
Unilateral sacral nerve stimulation dextra for 4 weeks
Device: Medtronic INTERSIM II - 3058
Medtronic INTERSIM II - 3058 Impuls Generator
Other Names:
  • Medtronic INTERSIM II - 3058
  • Impuls Generator
Experimental: Sinistra
Unilateral sacral nerve stimulation sinistra 4 weeks
Device: Medtronic INTERSIM II - 3058
Medtronic INTERSIM II - 3058 Impuls Generator
Other Names:
  • Medtronic INTERSIM II - 3058
  • Impuls Generator
Experimental: Bilateral
Bilateral sacral nerve stimulation 4 weeks
Device: Medtronic INTERSIM II - 3058
Medtronic INTERSIM II - 3058 Impuls Generator
Other Names:
  • Medtronic INTERSIM II - 3058
  • Impuls Generator

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00913601

Locations
Denmark
Anal Physiology Laboratory, Surgical Research Section 900, Aarhus University Hospital
Aarhus, Aarhus C, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
MEDTRONIC DANMARK A/S Arne Jacobsens Alle 17 DK-2300 København S Danmark
Investigators
Principal Investigator: Jakob K Jakobsen, MD Anal Physiology Laboratory, Surgical Research Section 900, Aarhus University Hospital, Denmark
  More Information

Publications:
Responsible Party: Jakob Jakobsen, M.D., University of Aarhus
ClinicalTrials.gov Identifier: NCT00913601     History of Changes
Other Study ID Numbers: 001
Study First Received: June 2, 2009
Last Updated: July 2, 2014
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
Idiopathic Fecal Incontinence
Fecal Incontinence
Sacral Nerve Stimulation
Sacral Nerve Neuromodulation

Additional relevant MeSH terms:
Fecal Incontinence
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 28, 2014