eCoin for OAB Feasibility Follow-on Study

Overactive Bladder Clinical Trial

Official title:

SUBCUTANEOUS TIBIAL NERVE STIMULATION FOR URGENCY URINARY INCONTINENCE: A FOLLOW-ON STUDY

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03655054
• Other study ID #: 111-3335
• Status: Completed
• Phase: N/A
• Start date: March 13, 2019
• Est. completion date: September 12, 2022

Study information

• Verified date: October 2022
• Source: Valencia Technologies Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: September 12, 2022
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Device:
• eCoin Tibial Nerve Stimulation
Subcutaneous stimulation of the tibial nerve using the eCoin device.

Locations

Country	Name	City	State
New Zealand	Urology Associates	Christchurch
New Zealand	Roundhay Medical Centre	Nelson
New Zealand	Tauranga Urology Research Ltd	Tauranga
United States	The Institute for Female Pelvic Medicine & Reconstructive Surgery (FPM Institute)	Allentown	Pennsylvania
United States	Alliance Urology Specialists	Greensboro	North Carolina
United States	The Clark Center for Urogynecology	Newport Beach	California
United States	UnityPoint Clinic	Waterloo	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Valencia Technologies Corporation

Countries where clinical trial is conducted

United States,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary.		12 weeks after device activation.
Primary	Safety in All Patients. All Adverse Events Will be Reported in All Patients Who Were Implanted 4 Months After Implantation.	Instances of a related adverse event.	16 weeks after device implantation.
Secondary	Change From Baseline in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary.		24 weeks after device activation.
Secondary	Safety in All Patients. All Adverse Events Will be Reported in All Patients Who Were Implanted 6 Months After Implantation.	Instances of a related adverse event	28 weeks after device implantation.