NCT05685433

A Real World Study of eCoin for Urgency Urinary Incontinence: Post Approval Evaluation (RECIPE)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Valencia Technologies Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A prospective, multicenter, single-arm study to evaluate the safety and effectiveness of the eCoin® implanted tibial nerve stimulator in subjects with urgency urinary incontinence (UUI).

Detailed description

The goal of this prospective, multicenter, single-arm study is to assess the long-term safety and effectiveness of the FDA approved eCoin® implanted tibial nerve stimulator in a real world setting. Eligible subjects having overactive bladder (OAB) with urgency urinary incontinence (UUI) will be implanted with the eCoin® implanted tibial stimulator and complete voiding diaries and questionnaires at follow-up visits through 5 years.

Conditions

• Overactive Bladder
• Urge Incontinence
• Incontinence, Urinary
• Urinary Urge Incontinence

Interventions

Type	Name	Description
DEVICE	eCoin Tibial Nerve Stimulation	Subcutaneous stimulation of the tibial nerve using the eCoin device.

Timeline

• Start date: 2023-01-26
• Primary completion: 2027-03-01
• Completion: 2031-12-01
• First posted: 2023-01-17
• Last updated: 2026-01-28

Locations

22 sites across 1 country: United States

Regulatory

• FDA-regulated device study