Efficacy of Sacral Nerve Stimulation Before Definitive Implantation (SNStest)

This study has been withdrawn prior to enrollment.
(slow recruitment)
Sponsor:
Information provided by:
University of Lausanne Hospitals
ClinicalTrials.gov Identifier:
NCT00522691
First received: August 28, 2007
Last updated: January 12, 2010
Last verified: August 2007
  Purpose

Sacral nerve stimulation (SNS) is an emerging treatment for patients with severe fecal incontinence. The test stimulation is minimally invasive, associated to low morbidity and relatively cheap. On the contrary, implantation of the definite stimulator is related to higher morbidity and considerable costs. A careful patent selection for definite implantation is therefore crucial. However, indication for implantation is actually based only on the subjective criteria reported in the patients´ diary only. Patients and care providers are likely to overestimate the real effect of SNS leading to an unjustified overuse of this expensive device. It is therefore necessary to evaluate real efficacy of SNS during the testing phase in a unbiased setting in order to avoid unnecessary morbidity and costs.


Condition Intervention
Fecal Incontinence
Procedure: sacral nerve stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Sacral Nerve Stimulation Before Definitive Implantation: a Multicenter Randomized, Double Blind, Crossover Trial

Resource links provided by NLM:


Further study details as provided by University of Lausanne Hospitals:

Primary Outcome Measures:
  • Primary success rate of SNS after 7 days. By convention this is assessed by >50% reduction in the number of episodes in the symptom diary. [ Time Frame: 24 months ]

Estimated Enrollment: 34
Study Start Date: September 2007
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Phase 1: sacral nerve stimulation crossover Phase 2 : sham stimulation
Procedure: sacral nerve stimulation
Experimental: B
Phase 1: sham stimulation crossover Phase 2: sacral nerve stimulation
Procedure: sacral nerve stimulation

Detailed Description:

Sacral nerve stimulation (SNS) is an emerging treatment for patients with severe faecal incontinence when conservative measures fail and surgical repair is not indicated. In a minimally-invasive approach and under local anaesthesia, an electrode is placed around sacral nerve root S2-4 and electrical stimulation is applied to the sacral spinal nerves. Effectiveness of SNS is definitively not only explained by placebo effect but the pathophysiologic mechanisms remain unclear. Suggested pathways include modulation of afferent nerve fibres and direct stimulation of the pelvic floor and anal sphincter muscle. After placement of the electrode, the patient is stimulated by an external stimulator for 1-3 weeks. During this period, the patient documents the number of faecal incontinence episodes or urgencies in a symptom diary. By convention, indication for permanent stimulation is based on a 50% reduction in the number of episodes. After a successful testing period, the permanent stimulator is implanted, generally in the upper gluteal region.

Previous studies report success rates up to 80%. The only randomized trial with a proper sample size evaluated the efficacy of SNS after definite implantation. In this study, 63% of the patients felt improved during the placebo period and might not really benefit from the device. The real success rate of SNS is therefore likely to be considerably lower. Efficacy of SNS during the testing phase has never been assessed in a blinded randomized study.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients admitted to SNS test for treatment of faecal incontinence after unsuccessful conservative (or surgical) treatment.

Exclusion criteria:

  • Absence of informed consent.
  • Patients not speaking french or german.
  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: NCT00522691

Locations
Switzerland
Visceral surgery, university hospital
Lausanne, Vaud, Switzerland, 1005
Sponsors and Collaborators
University of Lausanne Hospitals
Investigators
Principal Investigator: Martin Hubner, MD Visceral Surgery, University Lausanne, Switzerland
Study Director: Jean-Claude Givel, Professor Visceral Surgery, University Lausanne, Switzerland
Study Chair: Nicolas Demartines, Professor Visceral Surgery, University Lausanne, Switzerland
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00522691     History of Changes
Other Study ID Numbers: CHV120/07
Study First Received: August 28, 2007
Last Updated: January 12, 2010
Health Authority: Switzerland: Ethikkommission

Keywords provided by University of Lausanne Hospitals:
Fecal incontinence
sacral nerve stimulation

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

ClinicalTrials.gov processed this record on August 28, 2014