NCT03029624

eCoin Tibial Nerve Stimulation for OAB

Subcutaneous Tibial Nerve Stimulation for Urgency Urinary Incontinence

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Valencia Technologies Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Urgency Urinary Incontinence

Interventions

Type	Name	Description
DEVICE	eCoin	Patients are implanted with active implantable device called eCoin. eCoin is turned ON in order to deliver neuromodulation therapy.

Timeline

• Start date: 2017-04-03
• Primary completion: 2017-12-30
• Completion: 2018-10-01
• First posted: 2017-01-24
• Last updated: 2020-12-22
• Results posted: 2020-11-27

Locations

7 sites across 2 countries: United States, New Zealand

Regulatory

• FDA-regulated device study