Pivotal Study of eCoin for Overactive Bladder With Urgency Urinary Incontinence
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| ClinicalTrials.gov Identifier: NCT03556891 |
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Recruitment Status :
Active, not recruiting
First Posted : June 14, 2018
Results First Posted : July 30, 2021
Last Update Posted : July 30, 2021
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Sponsor:
Valencia Technologies Corporation
Information provided by (Responsible Party):
Valencia Technologies Corporation
- Study Details
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Overactive Bladder Urge Incontinence Incontinence, Urinary Urinary Urge Incontinence | Device: eCoin Tibial Nerve Stimulation | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 133 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Pivotal Study of Subcutaneous Tibial Nerve Stimulation With eCoin for Overactive Bladder (OAB) With Urgency Urinary Incontinence (UUI) |
| Actual Study Start Date : | September 4, 2018 |
| Actual Primary Completion Date : | April 12, 2020 |
| Estimated Study Completion Date : | April 12, 2022 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Urinary Incontinence
| Arm | Intervention/treatment |
|---|---|
| Experimental: eCoin Tibial Nerve Stimulation |
Device: eCoin Tibial Nerve Stimulation
Subcutaneous stimulation of the tibial nerve using the eCoin device. |
Primary Outcome Measures :
- 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 who were implanted 12 months after implantation.
Secondary Outcome Measures :
- Moderate-term Safety in All Patients. Percentage of Patients With Device or Implantation Related Adverse Events. [ Time Frame: 24 weeks after device activation ]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. [ Time Frame: 24 weeks after device activation ]Moderate-term effectiveness data, responder rate
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Primary 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.
Primary 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03556891
Locations
| United States, California | |
| Kaiser Permanente | |
| Downey, California, United States, 90242 | |
| Sequoia Urology Center | |
| Redwood City, California, United States, 94062 | |
| Kaiser Permanente | |
| San Diego, California, United States, 92110 | |
| Sansum Clinic | |
| Santa Barbara, California, United States, 93105 | |
| United States, Colorado | |
| SurgOne PC | |
| Englewood, Colorado, United States, 80113 | |
| United States, Connecticut | |
| Urology Associates of Norwalk | |
| Norwalk, Connecticut, United States, 06850 | |
| United States, Florida | |
| Florida Bladder Institute | |
| Naples, Florida, United States, 34109 | |
| United States, Illinois | |
| North Shore Medical Group | |
| Skokie, Illinois, United States, 60076 | |
| United States, Iowa | |
| UnityPoint Clinic | |
| Waterloo, Iowa, United States, 50703 | |
| United States, Maryland | |
| Chesapeake Urology | |
| Owings Mills, Maryland, United States, 21117 | |
| United States, Nebraska | |
| Adult & Pediatric Urology | |
| Omaha, Nebraska, United States, 68114 | |
| United States, New York | |
| Manhattan Medical Research | |
| New York, New York, United States, 10016 | |
| United States, North Carolina | |
| Alliance Urology Specialists | |
| Greensboro, North Carolina, United States, 27403 | |
| United States, Pennsylvania | |
| The Institute for Female Pelvic Medicine & Reconstructive Surgery (FPM Institute) | |
| Allentown, Pennsylvania, United States, 18103 | |
| United States, South Carolina | |
| South Carolina OB/GYN | |
| Columbia, South Carolina, United States, 29201 | |
Sponsors and Collaborators
Valencia Technologies Corporation
Investigators
| Principal Investigator: | Scott MacDiarmid, MD | Alliance Urology |
Study Documents (Full-Text)
Documents provided by Valencia Technologies Corporation:
Documents provided by Valencia Technologies Corporation:
Study Protocol [PDF] August 25, 2020
Statistical Analysis Plan [PDF] August 28, 2019
| Responsible Party: | Valencia Technologies Corporation |
| ClinicalTrials.gov Identifier: | NCT03556891 |
| Other Study ID Numbers: |
111-3281 |
| First Posted: | June 14, 2018 Key Record Dates |
| Results First Posted: | July 30, 2021 |
| Last Update Posted: | July 30, 2021 |
| Last Verified: | July 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | Yes |
| Device Product Not Approved or Cleared by U.S. FDA: | Yes |
Additional relevant MeSH terms:
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Urinary Incontinence Enuresis Urinary Bladder, Overactive Urinary Incontinence, Urge Urination Disorders Urologic Diseases |
Lower Urinary Tract Symptoms Urological Manifestations Behavioral Symptoms Elimination Disorders Mental Disorders Urinary Bladder Diseases |