eCoin for OAB Feasibility Follow-on Study

Not Applicable

Completed

• Conditions: Urge Incontinence; Urinary Urge Incontinence; Incontinence, Urinary; Overactive Bladder
• Interventions: Device: eCoin Tibial Nerve Stimulation

• Registration Number: NCT03655054
• Lead Sponsor: Valencia Technologies Corporation

Brief Summary

This trial is a prospective, multicenter, single-arm follow-on study will evaluate the safety and effectiveness of eCoinTM tibial nerve stimulation in subjects with urgency urinary incontinence (UUI) as defined by the American Urological Association (30). The follow-on study will evaluate changes from baseline in OAB symptoms as measured by voiding diaries and patient-reported outcomes through 24 weeks of eCoinTM therapy (which is the same as 28 weeks from study device reimplantation).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-29
• Study First Submitted QC: 2018-08-29
• Study First Posted: 2018-08-31
• Study Start: 2019-03-13
• Primary Completion: 2020-01-31
• Results First Submitted: 2021-03-29
• Results First Submitted QC: 2021-03-29
• Results First Posted: 2021-04-26
• Study Completion: 2022-09-12
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-11
• Last Update Posted: 2022-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

1. Individual participated in the eCoin Feasibility Study for Urgency Urinary Incontinence.
2. Individual was implanted with the study device during the eCoin Feasibility Study for Urgency Urinary Incontinence.

Exclusion Criteria

1. In the opinion of the investigator, individual is not a good candidate for participation in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
eCoin Tibial Nerve Stimulation	eCoin Tibial Nerve Stimulation	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary.	12 weeks after device activation.
Safety in All Patients. All Adverse Events Will be Reported in All Patients Who Were Implanted 4 Months After Implantation.	16 weeks after device implantation.	Instances of a related adverse event.

Secondary Outcome Measures

Name	Time	Method
Safety in All Patients. All Adverse Events Will be Reported in All Patients Who Were Implanted 6 Months After Implantation.	28 weeks after device implantation.	Instances of a related adverse event
Change From Baseline in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary.	24 weeks after device activation.

Trial Locations

Locations (7)

Alliance Urology Specialists; 🇺🇸 Greensboro, North Carolina, United States

The Institute for Female Pelvic Medicine & Reconstructive Surgery (FPM Institute); 🇺🇸 Allentown, Pennsylvania, United States

The Clark Center for Urogynecology; 🇺🇸 Newport Beach, California, United States

UnityPoint Clinic; 🇺🇸 Waterloo, Iowa, United States

Urology Associates; 🇳🇿 Christchurch, New Zealand

Roundhay Medical Centre; 🇳🇿 Nelson, New Zealand

Tauranga Urology Research Ltd; 🇳🇿 Tauranga, New Zealand