Pivotal Study of Subcutaneous Tibial Nerve Stimulation With eCoin for Overactive Bladder (OAB) With Urgency Urinary Incontinence (UUI)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Overactive Bladder
- Sponsor
- Valencia Technologies Corporation
- Enrollment
- 133
- Locations
- 14
- Primary Endpoint
- Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary.
- Status
- Completed
- Last Updated
- 7 months ago
Overview
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 Subjects who are no longer active, or have exited the study will be given the option to reenter the study and complete two follow-up visits.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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Women and men between 18 and 80 years old.
- •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.
- •Individual is without pharmacological treatment of overactive bladder (antimuscarinics and beta-3 agonists).
- •Individual is intolerant of or has an inadequate response to any of anticholinergics, β3-adrenoceptor agonists, onabotulinumtoxinA, or percutaneous tibial nerve stimulation.
Exclusion Criteria
- •Predominant stress urinary incontinence with more than 1/3 stress urinary incontinent episodes when compared to total urinary incontinent episodes.
- •Clinically significant bladder outlet obstruction.
- •Clinically significant pelvic organ prolapse beyond the hymenal ring.
- •Inadequate skin integrity or any evidence of an infection or inflammation in either lower leg.
Outcomes
Primary Outcomes
Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary.
Time Frame: 48 weeks after device activation.
Responder rate
Long-term Safety in All Patients. Percentage of Patients With Device Related Adverse Events.
Time Frame: 52 weeks after implantation.
All adverse events will be reported in all patients up to 52 weeks after implantation.
Secondary Outcomes
- Moderate-term Safety in All Patients. Percentage of Patients With Device Related Adverse Events.(28 weeks after implantation)
- 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)
- 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.)
- 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)
- Long-term Safety in All Patients: Percentage of Patients With Device Related Adverse Events.(96 weeks after implantation)
- Long-term Safety in All Patients: Percentage of Patients With Device Related Adverse Events(144 weeks after implantation)
- Long-term Safety in All Patients. Percentage of Patients With Device Related Adverse Events(257 weeks after implantation)