Efficacy of Sacral Nerve Stimulation Before Definitive Implantation

NCT ID: NCT00522691

Last Updated: 2015-06-24

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2009-12-31

Brief Summary

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.

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.

Conditions

Fecal Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

A: sacral first

Phase 1: sacral nerve stimulation crossover Phase 2 : sham stimulation

Group Type: EXPERIMENTAL

sacral nerve stimulation

Intervention Type: PROCEDURE

sacral nerve stimulation for fecal incontinence

B: sham first

Phase 1: sham stimulation crossover Phase 2: sacral nerve stimulation

Group Type: EXPERIMENTAL

sacral nerve stimulation

Intervention Type: PROCEDURE

sacral nerve stimulation for fecal incontinence

Interventions

sacral nerve stimulation

sacral nerve stimulation for fecal incontinence

Intervention Type: PROCEDURE

Eligibility 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Lausanne Hospitals

OTHER

Sponsor Role: lead

Responsible Party

Nicolas DEMARTINES

PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Martin Hubner, MD

Role: PRINCIPAL_INVESTIGATOR

Visceral Surgery, University Lausanne, Switzerland

Jean-Claude Givel, Professor

Role: STUDY_DIRECTOR

Visceral Surgery, University Lausanne, Switzerland

Nicolas Demartines, Professor

Role: STUDY_CHAIR

Visceral Surgery, University Lausanne, Switzerland

Locations

Visceral surgery, university hospital

Lausanne, Canton of Vaud, Switzerland

Countries

Switzerland

Other Identifiers

CHV120/07

Identifier Type: -

Identifier Source: org_study_id