Pivotal Study of eCoin for Overactive Bladder With Urgency Urinary Incontinence

Not Applicable

Completed

• Conditions: Urinary Urge Incontinence; Urge Incontinence; Incontinence, Urinary; Overactive Bladder

• Registration Number: NCT03556891
• Lead Sponsor: Valencia Technologies Corporation

Brief 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.

Detailed Description

This study enrolled and implanted 133 subjects at 15 sites in the US under the original IDE.

Subjects were given the option to extend out to 3 years post activation, with annual visits at 2 and 3 years post activation (96 and 144 weeks post-activation).

Subjects who are still active in the original IDE study will be offered consecutive enrollment in the post approval study and will be given the option to receive a new implant. Subjects who are no longer active, or have exited the study will be given the option to reenter the study and complete two follow-up visits. Subjects re-entering the study will not have the option to receive a new implant. Post approval follow-up of subjects will occur through the year 5 visit (257 weeks post-activation of their original device). Reimplantation of a new eCoin would not reset their follow-up clock.

Study Timeline

• Study First Submitted: 2018-05-22
• Study First Submitted QC: 2018-06-03
• Study First Posted: 2018-06-14
• Study Start: 2018-09-04
• Primary Completion: 2020-04-12
• Results First Submitted: 2021-06-18
• Results First Submitted QC: 2021-07-09
• Results First Posted: 2021-07-30
• Study Completion: 2024-09-18
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-16
• Last Update Posted: 2025-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 133

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, β3-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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary.	48 weeks after device activation.	Responder rate
Long-term Safety in All Patients. Percentage of Patients With Device Related Adverse Events.	52 weeks after implantation.	All adverse events will be reported in all patients up to 52 weeks after implantation.

Secondary Outcome Measures

Name	Time	Method
Moderate-term Safety in All Patients. Percentage of Patients With Device Related Adverse Events.	28 weeks after implantation	All adverse events will be reported.
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.	24 weeks after device activation	Moderate-term effectiveness data, responder rate
Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary	96 weeks after device activation.	Responder rate
Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary.	257 weeks after device activation	Responder rate
Long-term Safety in All Patients: Percentage of Patients With Device Related Adverse Events.	96 weeks after implantation	All adverse events will be reported in all patients up to 96 weeks after implantation.
Long-term Safety in All Patients: Percentage of Patients With Device Related Adverse Events	144 weeks after implantation	All adverse events will be reported in all patients up to 144 weeks after implantation.
Long-term Safety in All Patients. Percentage of Patients With Device Related Adverse Events	257 weeks after implantation	All adverse events will be reported in all patients up to 257 weeks after implantation.

Trial Locations

Locations (14)

Kaiser Permanente; 🇺🇸 San Diego, California, United States

Sequoia Urology Center; 🇺🇸 Redwood City, California, United States

Sansum Clinic; 🇺🇸 Santa Barbara, California, United States

SurgOne PC; 🇺🇸 Englewood, Colorado, United States

Urology Associates of Norwalk; 🇺🇸 Norwalk, Connecticut, United States

Florida Bladder Institute; 🇺🇸 Naples, Florida, United States

North Shore Medical Group; 🇺🇸 Skokie, Illinois, United States

UnityPoint Clinic; 🇺🇸 Waterloo, Iowa, United States

Chesapeake Urology; 🇺🇸 Owings Mills, Maryland, United States

Adult & Pediatric Urology; 🇺🇸 Omaha, Nebraska, United States

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