NCT01023269

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: MedtronicNeuro · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neurogenic Overactive Bladder
• Urinary Incontinence
• Detrusor Overactivity

Interventions

Type	Name	Description
DEVICE	InterStim Therapy	Neuromodulation therapy which delivers low level electrical stimulation to bladder wall for the treatment of overactive bladder with urinary incontinence.

Timeline

• Start date: 2009-12-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2009-12-02
• Last updated: 2019-01-31
• Results posted: 2019-01-31

Locations

8 sites across 6 countries: Belgium, France, Germany, Italy, Netherlands, United Kingdom