Efficacy Study of Pudendal Neuromodulation for the Treatment of Neurogenic Overactive Bladder (ACCEPTANCE)

January 30, 2019 updated by: MedtronicNeuro

Phase IV, Multi-center, Randomized, Cross-over Study to Demonstrate the Efficacy of Pudendal Neuromodulation for the Treatment of Neurogenic Overactive Bladder

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The Medtronic InterStim device delivers stimulation therapy for the treatment of chronic intractable (functional) disorders of the pelvis and lower urinary or intestinal tract through the sacral nerve or the pudendal nerve systems.

This trial is designed to demonstrate that neuromodulation of the pudendal nerve will effectively treat patients with neurogenic overactive bladder. Symptoms of urinary incontinence are compared when stimulation is switched on for 4 weeks to stimulation switched off for 4 weeks. After the eight week crossover period, all patients receive treatment and are followed up within the study for 12 months post implant.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Gent, Belgium
        • Universitair Ziekenhuis Gent
  • France
      • Lyon, France
        • Centre Hospitalier Universitaire de Lyon-Sud
      • Paris, France
        • Hopital de la Pitie Salpetriere
  • Germany
      • Herne, Germany, 44627
        • Marienhospital Herne, Klinikum Der Ruhr-Universitaet Bochum
      • Tübingen, Germany
        • Klinik für Urologie Oberarzt-Sekretaria
  • Italy
      • Milan, Italy, 20162
        • Niguarda Ospedale Ca' Granda
  • Netherlands
      • Maastricht, Netherlands
        • Academisch Ziekenhuis
  • United Kingdom
      • London, United Kingdom
        • National Hospital For Neurology and Neurosurgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Incomplete upper motor neuron lesion
  • Detrusor overactivity
  • Two leaks or two notices of leaks per day
  • Mean functional bladder capacity (volume voided per episode) of ≥100 ml

Exclusion Criteria:

  • Complete spinal lesion or complete bilateral lesion of sacral / pudendal nerves.
  • Degenerative disease of the central nervous system

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: ON / OFF
Stimulation ON for 4 weeks, followed by stimulation OFF for 4 weeks.
Device: InterStim Therapy
Neuromodulation therapy which delivers low level electrical stimulation to bladder wall for the treatment of overactive bladder with urinary incontinence.
Other: OFF / ON
Stimulation OFF for 4 weeks, followed by stimulation ON for 4 weeks.
Device: InterStim Therapy
Neuromodulation therapy which delivers low level electrical stimulation to bladder wall for the treatment of overactive bladder with urinary incontinence.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Bladder Capacity
Time Frame: Baseline, 4 weeks after implant, 8 weeks after implant
Functional Bladder capacity is measured as the average passed volume per episode, in milliliters, as recorded in the patient's voiding diary during the observation period. Due to the small number of patients in each group, the summary on the functional bladder capacity was provided for the combined groups.
Baseline, 4 weeks after implant, 8 weeks after implant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MedtronicNeuro

Investigators

  • Principal Investigator: Michele Spinelli, MD, Ospedale Niguarda Ca' Granda, Milan, Italy
  • Principal Investigator: Karel Everaert, MD, University Ghent
  • Principal Investigator: Philip Van Kerrebroeck, MD, Academisch Ziekenhuis, Maastricht, The Netherlands
  • Principal Investigator: Emmanuel Chartier-Kastler, MD, Hôpital de la Pitié Salpétrière, Paris, France
  • Principal Investigator: Arndt Van Ophoven, MD, Marienhospital Herne Klinikum der Ruhr-Universität, Herne, Germany
  • Principal Investigator: Karl Sievert, MD, Klinik für Urologie Oberarzt-Sekretariat, Tübingen, Germany
  • Principal Investigator: Suzy Elneil, MD, National Hospital for Neurology and Neurosurgery, London, UK

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

November 30, 2009

First Submitted That Met QC Criteria

December 1, 2009

First Posted (Estimate)

December 2, 2009

Study Record Updates

Last Update Posted (Actual)

January 31, 2019

Last Update Submitted That Met QC Criteria

January 30, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1.02.7004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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