Urinary Incontinence Clinical Trial
— ACCEPTANCEOfficial title:
Phase IV, Multi-center, Randomized, Cross-over Study to Demonstrate the Efficacy of Pudendal Neuromodulation for the Treatment of Neurogenic Overactive Bladder
NCT number | NCT01023269 |
Other study ID # | 1.02.7004 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | December 2009 |
Est. completion date | June 2012 |
Verified date | January 2019 |
Source | MedtronicNeuro |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 17 |
Est. completion date | June 2012 |
Est. primary completion date | June 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Belgium | Universitair Ziekenhuis Gent | Gent | |
France | Centre Hospitalier Universitaire de Lyon-Sud | Lyon | |
France | Hôpital de la Pitié Salpétrière | Paris | |
Germany | Marienhospital Herne, Klinikum der Ruhr-Universitaet Bochum | Herne | |
Germany | Klinik für Urologie Oberarzt-Sekretaria | Tübingen | |
Italy | Niguarda Ospedale Ca' Granda | Milan | |
Netherlands | Academisch Ziekenhuis | Maastricht | |
United Kingdom | National Hospital for Neurology and Neurosurgery | London |
Lead Sponsor | Collaborator |
---|---|
MedtronicNeuro |
Belgium, France, Germany, Italy, Netherlands, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Functional Bladder Capacity | 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 |
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