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

Urinary Incontinence Clinical Trial

— ACCEPTANCE  

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 Details — Status: Terminated

Administrative data

• NCT number: NCT01023269
• Other study ID #: 1.02.7004
• Status: Terminated
• Phase: N/A
• Start date: December 2009
• Est. completion date: June 2012

Study information

• Verified date: January 2019
• Source: MedtronicNeuro
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Detrusor Overactivity
• Enuresis
• Neurogenic Overactive Bladder
• Urinary Bladder, Overactive
• Urinary Incontinence

Intervention

Device:
• InterStim Therapy
Neuromodulation therapy which delivers low level electrical stimulation to bladder wall for the treatment of overactive bladder with urinary incontinence.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
MedtronicNeuro

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Italy,  Netherlands,  United Kingdom, 

Outcome

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