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

Urinary Incontinence Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01023269
Study type Interventional
Source MedtronicNeuro
Contact
Status Terminated
Phase N/A
Start date December 2009
Completion date June 2012
View Details
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