Overactive Bladder Clinical Trial
Official title:
Pivotal Study of Subcutaneous Tibial Nerve Stimulation With eCoin for Overactive Bladder (OAB) With Urgency Urinary Incontinence (UUI)
Verified date | January 2024 |
Source | Valencia Technologies Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Valencia Technologies Corporation |
United States,
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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