Efficacy of Sacral Nerve Stimulation Before Definitive Implantation

NCT00522691 | Withdrawn DMC

• 1 other identifier: CHV120/07
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Fecal Incontinence

Keywords

Fecal incontinence; sacral nerve stimulation

Outcome Measures

Primary Outcomes (1)

• 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.

  24 months

Study Arms (2)

A: sacral first

EXPERIMENTAL

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

Procedure: sacral nerve stimulation

B: sham first

EXPERIMENTAL

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

Procedure: sacral nerve stimulation

Interventions

sacral nerve stimulation PROCEDURE

sacral nerve stimulation for fecal incontinence

A: sacral first; B: sham first

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Lausanne Hospitals: lead

Study Sites (1)

Visceral surgery, university hospital

Lausanne, Canton of Vaud, 1005, Switzerland

Location

MeSH Terms

Conditions

Fecal Incontinence

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Martin Hubner, MD

  Visceral Surgery, University Lausanne, Switzerland

  PRINCIPAL INVESTIGATOR

• Jean-Claude Givel, Professor

  Visceral Surgery, University Lausanne, Switzerland

  STUDY DIRECTOR

• Nicolas Demartines, Professor

  Visceral Surgery, University Lausanne, Switzerland

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: August 28, 2007
• First Posted: August 30, 2007
• Study Start: September 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: June 24, 2015

Record last verified: 2015-06

Locations

CH (1)