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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03556891
Other study ID # 111-3281
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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