eCoin Tibial Nerve Stimulation for OAB

Urgency Urinary Incontinence Clinical Trial

Official title: Subcutaneous Tibial Nerve Stimulation for Urgency Urinary Incontinence

Status Completed

Clinical Trial Summary

The study is a single arm, prospective study of the safety and effectiveness of the Valencia Technologies eCoin System to stimulate the tibial nerve for the treatment of patients with refractory urgency urinary incontinence.

Clinical Trial Description

This trial is a single arm, prospective study of the safety and effectiveness of eCoin tibial nerve stimulation in 25 subjects with refractory overactive bladder as defined by the American Urological Association.. The eCoin neuromodulation device will be implanted subcutaneously in the right or left leg of patients with urgency urinary incontinence. After a 4 week implant healing period, subjects will have their devices activated (turned ON). After 3 months of device therapy (occurring 4 months post-implant), the primary endpoint will be assessed. It is anticipated that subjects will reach the full therapeutic effect at approximately 3 months of therapy. Subjects will be followed for an additional 9 months to assess the safety of maintenance stimulation therapy with fewer sessions occurring during this time interval. ;

Related Conditions & MeSH terms

• Enuresis
• Urgency Urinary Incontinence
• Urinary Incontinence

• NCT number: NCT03029624
• Study type: Interventional
• Source: Valencia Technologies Corporation
• Status: Completed
• Phase: N/A
• Start date: April 3, 2017
• Completion date: October 1, 2018