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Efficacy Study of Pudendal Neuromodulation for the Treatment of Neurogenic Overactive Bladder

NCT01023269 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2019-01-31

Study results available
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Summary

The study is designed to demonstrate that treatment with low level stimulation of the bladder muscles reduces symptoms of urinary incontinence in comparison with no stimulation.

Conditions

Interventions

DEVICE

InterStim Therapy

Neuromodulation therapy which delivers low level electrical stimulation to bladder wall for the treatment of overactive bladder with urinary incontinence.

Sponsors & Collaborators

  • MedtronicNeuro

    lead INDUSTRY

Principal Investigators

  • Michele Spinelli, MD · Ospedale Niguarda Ca' Granda, Milan, Italy

  • Karel Everaert, MD · University Ghent

  • Philip Van Kerrebroeck, MD · Academisch Ziekenhuis, Maastricht, The Netherlands

  • Emmanuel Chartier-Kastler, MD · Hôpital de la Pitié Salpétrière, Paris, France

  • Arndt Van Ophoven, MD · Marienhospital Herne Klinikum der Ruhr-Universität, Herne, Germany

  • Karl Sievert, MD · Klinik für Urologie Oberarzt-Sekretariat, Tübingen, Germany

  • Suzy Elneil, MD · National Hospital for Neurology and Neurosurgery, London, UK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • Belgium
  • France
  • Germany
  • Italy
  • Netherlands
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT01023269 on ClinicalTrials.gov