Sacral Nerve Stimulation for Anal Incontinence and Bowel Control

Summary

Multicenter European study to evaluate efficacy and safety of sacral nerve stimulation with InterStim Therapy to treat fecal incontinence or constipation

Conditions

• Fecal Incontinence and Constipation

Interventions

DEVICE

Type: Implantable neurostimulator; InterStim

Treatment with InterStim Therapy: all patients meeting inclusion/exclusion criteria undergo test screening and those who have successful outcomes receive a permanent implant.

Sponsors & Collaborators

• MedtronicNeuro

  lead INDUSTRY

Principal Investigators

• Klaus Matzel, MD · University Hospital Erlangen- Erlangen, Germany

• Michael A Kamm, MD · St. Vincent's Hospital- Melbourne, Australia. Former: St. Mark's Hospital, London, U.K.

• Cor Baeten, MD · Maastricht University Hospital- The Netherlands

• John Christiansen, MD · Herlev Hospital- Copenhagen, Denmark

• Anders Mellgren, MD · Danderyd Hospital- Stockholm, Sweden

• Harald Rosen, MD · Danube Hospital/SMZ-Ost- Vienna, Austria

• Albert Navarro, MD · Hospital Mutua de Terrassa- Terrassa, Spain

• Robert Madoff, MD · University of Minnesota- Minneapolis, USA

• Carolynne Vaizey, MD · St. Mark's Hospital- London, UK

• Claes Johansson, MD · Danderyd Hospital- Stockholm, Sweden

• Soren Laurberg, MD · Aarhus University Hospital

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

1998-11-30

Primary Completion

2006-12-31

Completion

2012-09-30

Countries

• United States
• Austria
• Denmark
• Germany
• Netherlands
• Spain
• Sweden
• United Kingdom

Study Locations