Clinical trial NCT01023269: Efficacy Study of Pudendal Neuromodulation for the Treatment of Neurogenic Overactive Bladder
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Neurogenic Overactive Bladder
Urinary Incontinence
Detrusor Overactivity
Keywords: 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
Lead sponsor: MedtronicNeuro
Sponsor class: INDUSTRY
First posted: 2009-12-02
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Functional Bladder Capacity
timeFrame: Baseline, 4 weeks after implant, 8 weeks after implant
Secondary outcomes:
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Lyon
country: France
facility: Centre Hospitalier Universitaire de Lyon-Sud
city: Paris
country: France
facility: Hôpital de la Pitié Salpétrière
city: Herne
country: Germany
facility: Marienhospital Herne, Klinikum der Ruhr-Universitaet Bochum
city: Tübingen
country: Germany
facility: Klinik für Urologie Oberarzt-Sekretaria
city: Milan
country: Italy
facility: Niguarda Ospedale Ca' Granda
city: Maastricht
country: Netherlands
facility: Academisch Ziekenhuis
city: London
country: United Kingdom
facility: National Hospital for Neurology and Neurosurgery
Study officials:
affiliation: Ospedale Niguarda Ca' Granda, Milan, Italy
name: Michele Spinelli, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Ghent
name: Karel Everaert, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Academisch Ziekenhuis, Maastricht, The Netherlands
name: Philip Van Kerrebroeck, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital de la Pitié Salpétrière, Paris, France
name: Emmanuel Chartier-Kastler, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Marienhospital Herne Klinikum der Ruhr-Universität, Herne, Germany
name: Arndt Van Ophoven, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Klinik für Urologie Oberarzt-Sekretariat, Tübingen, Germany
name: Karl Sievert, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Hospital for Neurology and Neurosurgery, London, UK
name: Suzy Elneil, MD
role: PRINCIPAL_INVESTIGATOR
References: