Pivotal Study of eCoin for Overactive Bladder With Urgency Urinary Incontinence

Overactive Bladder Clinical Trial

Official title:

Pivotal Study of Subcutaneous Tibial Nerve Stimulation With eCoin for Overactive Bladder (OAB) With Urgency Urinary Incontinence (UUI)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03556891
• Other study ID #: 111-3281
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 4, 2018
• Est. completion date: April 28, 2024

Study information

• Verified date: January 2024
• 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 study of the safety and effectiveness of eCoinTM tibial nerve stimulation in subjects having overactive bladder (OAB) with urgency urinary incontinence (UUI). The study will evaluate changes from baseline in OAB symptoms as measured by voiding diaries and patient reported-outcomes through 48 weeks of eCoinTM therapy or 52 weeks of implantation.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 133
• Est. completion date: April 28, 2024
• Est. primary completion date: April 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Primary Inclusion Criteria:

1. Women and men between 18 and 80 years old.

2. Diagnosis of overactive bladder with urgency urinary incontinence or mixed urge and stress incontinence with a predominant urgency component (selfreported), for at least 6 months.

3. Individual is without pharmacological treatment of overactive bladder (antimuscarinics and beta-3 agonists).

4. Individual is intolerant of or has an inadequate response to any of anticholinergics, ß3-adrenoceptor agonists, onabotulinumtoxinA, or percutaneous tibial nerve stimulation.

Primary Exclusion Criteria:

1. Predominant stress urinary incontinence with more than 1/3 stress urinary incontinent episodes when compared to total urinary incontinent episodes.

2. Clinically significant bladder outlet obstruction.

3. Clinically significant pelvic organ prolapse beyond the hymenal ring.

4. Inadequate skin integrity or any evidence of an infection or inflammation in either lower leg.

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
United States	The Institute for Female Pelvic Medicine & Reconstructive Surgery (FPM Institute)	Allentown	Pennsylvania
United States	South Carolina OB/GYN	Columbia	South Carolina
United States	Kaiser Permanente	Downey	California
United States	SurgOne PC	Englewood	Colorado
United States	Alliance Urology Specialists	Greensboro	North Carolina
United States	Florida Bladder Institute	Naples	Florida
United States	Manhattan Medical Research	New York	New York
United States	Urology Associates of Norwalk	Norwalk	Connecticut
United States	Adult & Pediatric Urology	Omaha	Nebraska
United States	Chesapeake Urology	Owings Mills	Maryland
United States	Sequoia Urology Center	Redwood City	California
United States	Kaiser Permanente	San Diego	California
United States	Sansum Clinic	Santa Barbara	California
United States	North Shore Medical Group	Skokie	Illinois
United States	UnityPoint Clinic	Waterloo	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Valencia Technologies Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary.	Responder rate	48 weeks after device activation.
Primary	Long-term Safety in All Patients. Percentage of Patients With Device Related Adverse Events.	All adverse events will be reported in all patients who were implanted 12 months after implantation.	52 weeks after implantation.
Secondary	Moderate-term Safety in All Patients. Percentage of Patients With Device or Implantation Related Adverse Events.	All adverse events will be reported.	24 weeks after device activation
Secondary	Moderate-term Effectiveness Data. Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary.	Moderate-term effectiveness data, responder rate	24 weeks after device activation