Clinical trial NCT03655054: eCoin for OAB Feasibility Follow-on Study
Official title: SUBCUTANEOUS TIBIAL NERVE STIMULATION FOR URGENCY URINARY INCONTINENCE: A FOLLOW-ON STUDY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overactive Bladder
Urge Incontinence
Incontinence, Urinary
Urinary Urge Incontinence
Lead sponsor: Valencia Technologies Corporation
Sponsor class: INDUSTRY
First posted: 2018-08-31
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial is a prospective, multicenter, single-arm follow-on study will evaluate the safety and effectiveness of eCoinTM tibial nerve stimulation in subjects with urgency urinary incontinence (UUI) as defined by the American Urological Association (30). The follow-on study will evaluate changes from baseline in OAB symptoms as measured by voiding diaries and patient-reported outcomes through 24 weeks of eCoinTM therapy (which is the same as 28 weeks from study device reimplantation).


Eligibility criteria: Inclusion Criteria:

1. Individual participated in the eCoin Feasibility Study for Urgency Urinary Incontinence.
2. Individual was implanted with the study device during the eCoin Feasibility Study for Urgency Urinary Incontinence.

Exclusion Criteria:

1. In the opinion of the investigator, individual is not a good candidate for participation in the study.

Primary outcomes:
measure: Change From Baseline in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary.
timeFrame: 12 weeks after device activation.
measure: Safety in All Patients. All Adverse Events Will be Reported in All Patients Who Were Implanted 4 Months After Implantation.
timeFrame: 16 weeks after device implantation.
Secondary outcomes:
measure: Change From Baseline in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary.
timeFrame: 24 weeks after device activation.
measure: Safety in All Patients. All Adverse Events Will be Reported in All Patients Who Were Implanted 6 Months After Implantation.
timeFrame: 28 weeks after device implantation.
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: The Clark Center for Urogynecology
state: California
city: Waterloo
country: United States
facility: UnityPoint Clinic
state: Iowa
city: Greensboro
country: United States
facility: Alliance Urology Specialists
state: North Carolina
city: Allentown
country: United States
facility: The Institute for Female Pelvic Medicine & Reconstructive Surgery (FPM Institute)
state: Pennsylvania
city: Christchurch
country: New Zealand
facility: Urology Associates
city: Nelson
country: New Zealand
facility: Roundhay Medical Centre
city: Tauranga
country: New Zealand
facility: Tauranga Urology Research Ltd
Study officials:
References:
citation: Kaaki B, English S, Gilling P, Meffan P, Lucente V, MacDiarmid S, Clark M, Sen SK. Six-Month Outcomes of Reimplantation of a Coin-Sized Tibial Nerve Stimulator for the Treatment of Overactive Bladder Syndrome With Urgency Urinary Incontinence. Female Pelvic Med Reconstr Surg. 2022 May 1;28(5):287-292. doi: 10.1097/SPV.0000000000001105. Epub 2022 Sep 22.