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Efficacy of Sacral Nerve Stimulation Before Definitive Implantation

NCT00522691 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2015-06-24

No results posted yet for this study

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.

Conditions

  • Fecal Incontinence

Interventions

PROCEDURE

sacral nerve stimulation

sacral nerve stimulation for fecal incontinence

Sponsors & Collaborators

  • University of Lausanne Hospitals

    lead OTHER

Principal Investigators

  • Martin Hubner, MD · Visceral Surgery, University Lausanne, Switzerland

  • Jean-Claude Givel, Professor · Visceral Surgery, University Lausanne, Switzerland

  • Nicolas Demartines, Professor · Visceral Surgery, University Lausanne, Switzerland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00522691 on ClinicalTrials.gov