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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01023269
Recruitment Status : Terminated (difficulty in the enrolment)
First Posted : December 2, 2009
Results First Posted : January 31, 2019
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
MedtronicNeuro

Brief 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.

Condition or disease Intervention/treatment Phase
Neurogenic Overactive Bladder Urinary Incontinence Detrusor Overactivity Device: InterStim Therapy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase IV, Multi-center, Randomized, Cross-over Study to Demonstrate the Efficacy of Pudendal Neuromodulation for the Treatment of Neurogenic Overactive Bladder
Study Start Date : December 2009
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

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.




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01023269


Locations
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Belgium
Universitair Ziekenhuis Gent
Gent, Belgium
France
Centre Hospitalier Universitaire de Lyon-Sud
Lyon, France
Hôpital de la Pitié Salpétrière
Paris, France
Germany
Marienhospital Herne, Klinikum der Ruhr-Universitaet Bochum
Herne, Germany, 44627
Klinik für Urologie Oberarzt-Sekretaria
Tübingen, Germany
Italy
Niguarda Ospedale Ca' Granda
Milan, Italy, 20162
Netherlands
Academisch Ziekenhuis
Maastricht, Netherlands
United Kingdom
National Hospital for Neurology and Neurosurgery
London, United Kingdom
Sponsors and Collaborators
MedtronicNeuro
Investigators
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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

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Responsible Party: MedtronicNeuro
ClinicalTrials.gov Identifier: NCT01023269     History of Changes
Other Study ID Numbers: 1.02.7004
First Posted: December 2, 2009    Key Record Dates
Results First Posted: January 31, 2019
Last Update Posted: January 31, 2019
Last Verified: January 2019

Keywords provided by MedtronicNeuro:
Neurogenic overactive bladder
Urinary incontinence due to incomplete spinal cord injury
Neuromodulation
Neuromodulation for treatment of neurogenic overactive bladder
Patients with Urge urinary incontinence and detrusor overactivity

Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urinary Bladder, Overactive
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Urinary Bladder Diseases