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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03655054
Registration number
NCT03655054
Ethics application status
Date submitted
29/08/2018
Date registered
31/08/2018
Date last updated
17/10/2022
Titles & IDs
Public title
eCoin for OAB Feasibility Follow-on Study
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Scientific title
SUBCUTANEOUS TIBIAL NERVE STIMULATION FOR URGENCY URINARY INCONTINENCE: A FOLLOW-ON STUDY
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Secondary ID [1]
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111-3335
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Overactive Bladder
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Urge Incontinence
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Incontinence, Urinary
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Urinary Urge Incontinence
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Condition category
Condition code
Renal and Urogenital
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0
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Other renal and urogenital disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - eCoin Tibial Nerve Stimulation
Experimental: eCoin Tibial Nerve Stimulation -
Treatment: Devices: eCoin Tibial Nerve Stimulation
Subcutaneous stimulation of the tibial nerve using the eCoin device.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary.
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Assessment method [1]
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Timepoint [1]
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12 weeks after device activation.
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Primary outcome [2]
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Safety in All Patients. All Adverse Events Will be Reported in All Patients Who Were Implanted 4 Months After Implantation.
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Assessment method [2]
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Instances of a related adverse event.
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Timepoint [2]
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16 weeks after device implantation.
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Secondary outcome [1]
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Change From Baseline in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary.
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Assessment method [1]
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Timepoint [1]
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24 weeks after device activation.
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Secondary outcome [2]
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Safety in All Patients. All Adverse Events Will be Reported in All Patients Who Were Implanted 6 Months After Implantation.
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Assessment method [2]
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Instances of a related adverse event
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Timepoint [2]
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28 weeks after device implantation.
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. In the opinion of the investigator, individual is not a good candidate for participation
in the study.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
13/03/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
12/09/2022
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Sample size
Target
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Accrual to date
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Final
23
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Iowa
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Country [3]
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United States of America
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State/province [3]
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North Carolina
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Country [4]
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United States of America
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State/province [4]
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Pennsylvania
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Country [5]
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New Zealand
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State/province [5]
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Christchurch
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Country [6]
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New Zealand
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State/province [6]
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Nelson
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Country [7]
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New Zealand
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State/province [7]
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Tauranga
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Valencia Technologies Corporation
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03655054
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03655054
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