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

Not Applicable

Terminated

• Conditions: Neurogenic Overactive Bladder; Urinary Incontinence; Detrusor Overactivity
• Interventions: Device: InterStim Therapy

• Registration Number: NCT01023269
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2009-11-30
• Study Start: 2009-12
• Study First Submitted QC: 2009-12-01
• Study First Posted: 2009-12-02
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Results First Submitted: 2016-05-18
• Status Verified: 2019-01
• Results First Submitted QC: 2019-01-30
• Last Update Submitted: 2019-01-30
• Results First Posted: 2019-01-31
• Last Update Posted: 2019-01-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 17

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
OFF / ON	InterStim Therapy	Stimulation OFF for 4 weeks, followed by stimulation ON for 4 weeks.
ON / OFF	InterStim Therapy	Stimulation ON for 4 weeks, followed by stimulation OFF for 4 weeks.

Primary Outcome Measures

Name	Time	Method
Functional Bladder Capacity	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.

Trial Locations

Locations (8)

Universitair Ziekenhuis Gent; 🇧🇪 Gent, Belgium

Centre Hospitalier Universitaire de Lyon-Sud; 🇫🇷 Lyon, France

Hôpital de la Pitié Salpétrière; 🇫🇷 Paris, France

National Hospital for Neurology and Neurosurgery; 🇬🇧 London, United Kingdom

Academisch Ziekenhuis; 🇳🇱 Maastricht, Netherlands

Niguarda Ospedale Ca' Granda; 🇮🇹 Milan, Italy

Marienhospital Herne, Klinikum der Ruhr-Universitaet Bochum; 🇩🇪 Herne, Germany

Klinik für Urologie Oberarzt-Sekretaria; 🇩🇪 Tübingen, Germany