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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
Scientific title
SUBCUTANEOUS TIBIAL NERVE STIMULATION FOR URGENCY URINARY INCONTINENCE: A FOLLOW-ON STUDY
Secondary ID [1] 0 0
111-3335
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overactive Bladder 0 0
Urge Incontinence 0 0
Incontinence, Urinary 0 0
Urinary Urge Incontinence 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary.
Timepoint [1] 0 0
12 weeks after device activation.
Primary outcome [2] 0 0
Safety in All Patients. All Adverse Events Will be Reported in All Patients Who Were Implanted 4 Months After Implantation.
Timepoint [2] 0 0
16 weeks after device implantation.
Secondary outcome [1] 0 0
Change From Baseline in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary.
Timepoint [1] 0 0
24 weeks after device activation.
Secondary outcome [2] 0 0
Safety in All Patients. All Adverse Events Will be Reported in All Patients Who Were Implanted 6 Months After Implantation.
Timepoint [2] 0 0
28 weeks after device implantation.

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.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. In the opinion of the investigator, individual is not a good candidate for participation
in the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/03/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/09/2022
Sample size
Target
Accrual to date
Final
23
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Iowa
Country [3] 0 0
United States of America
State/province [3] 0 0
North Carolina
Country [4] 0 0
United States of America
State/province [4] 0 0
Pennsylvania
Country [5] 0 0
New Zealand
State/province [5] 0 0
Christchurch
Country [6] 0 0
New Zealand
State/province [6] 0 0
Nelson
Country [7] 0 0
New Zealand
State/province [7] 0 0
Tauranga

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Valencia Technologies Corporation
Address
Country

Ethics approval
Ethics application status

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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT03655054
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries