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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03029624




Registration number
NCT03029624
Ethics application status
Date submitted
20/01/2017
Date registered
24/01/2017
Date last updated
14/09/2018

Titles & IDs
Public title
eCoin Tibial Nerve Stimulation for OAB
Scientific title
Subcutaneous Tibial Nerve Stimulation for Urgency Urinary Incontinence
Secondary ID [1] 0 0
111-3175
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Urgency Urinary 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

Experimental: Treatment Arm - Treatment Arm receives implanted eCoin device and therapy is turned ON.


Treatment: Devices: eCoin
Patients are implanted with active implantable device called eCoin. eCoin is turned ON in order to deliver neuromodulation therapy.

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incontinent Episodes - The change in number of incontinence episodes from baseline to three months post-activation.
Timepoint [1] 0 0
Baseline to three months post-activation.
Secondary outcome [1] 0 0
System and Procedure Related AEs - Incidence of System and Procedure Related Adverse Events from implantation to one month post-implantation.
Timepoint [1] 0 0
Implantation to one month post-implantation.
Secondary outcome [2] 0 0
MAEs - Incidence of all Major Adverse Events from baseline to 3 months post-activation.
Timepoint [2] 0 0
Baseline to 3 months post-activation.

Eligibility
Key inclusion criteria
1. Women and men 18 years and older.

2. Diagnosis of overactive bladder with urgency urinary incontinence or mixed urge and
stress incontinence with a predominant urgency component, for at least 6 months
(self-reported).

3. Individual has at least four urgency incontinence episodes on a three-day voiding
diary with at least one episode per 24 hour time period

4. Individual with urinary frequency, defined as an average of greater than or equal to 8
times/24 hours (ie. a total of greater than or equal to 24 micturitions on a 3 day
diary)

5. Individual is unresponsive to, inadequately responsive to, or intolerant of
behavioral, rehabilitation, and pharmacologic therapy.

6. Individual is able to give his or her written, informed consent.

7. Individual is mentally competent and able to understand all study requirements.

8. Individual is willing and able to complete a 3-day voiding diary and quality of life
questionnaire.

9. Individual is without pharmacological treatment of overactive bladder (antimuscarinics
and beta-3 agonists) for 2 weeks prior to screening.

10. The individual demonstrates a positive nerve integrity test.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Individual has predominantly stress urinary incontinence

2. Individual has clinically significant bladder outlet obstruction.

3. Individual has clinically significant pelvic organ prolapse.

4. Individual has abnormal post void residual (i.e., greater than 150 cc).

5. Individual has clinically significant urethral stricture disease or bladder neck
contracture

6. Individual has an active urinary tract infection at time of enrollment.

7. Individual has recurrent urinary tract infections defined as 4 or more UTI's per year.

8. Individual has morbid obesity.

9. Individual has had positive urine cytology or diagnosis of bladder or prostate cancer.

10. Individual has neurogenic bladder dysfunction.

11. Individual is taking an alpha-blocker for benign prostatic hyperplasia.

12. Individual is pregnant or intends to become pregnant during the study.

13. Patient is breast feeding or is less than 9-month post-partum.

14. Individual has the presence of urinary fistula, bladder stone, or interstitial
cystitis.

15. Individual has uncontrolled diabetes mellitus.

16. Individual has a cardiac pacemaker or implanted defibrillator.

17. Individual has been previously treated with sacral nerve stimulation.

18. Individual has been treated with onabotulinumtoxinA in the previous 9 months prior to
enrollment.

19. Individual has been treated with percutaneous tibial nerve stimulation within the
previous 12 weeks prior to enrollment.

20. Individual requires regular Magnetic Resonance Imaging for other health care
conditions. (ASK)

21. Individual has a clotting or bleeding disorder; antiplatelet and anticoagulant therapy
may be continued or held at the discretion of the investigator

22. Individual has a clinically significant peripheral neuropathy.

23. Individual is neutropenic or immunocompromised.

Study design
Purpose of the study
Treatment
Allocation to intervention
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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
The study is a single arm, prospective study of the safety and effectiveness of the Valencia
Technologies eCoin System to stimulate the tibial nerve for the treatment of patients with
refractory urgency urinary incontinence.
Trial website
https://clinicaltrials.gov/show/NCT03029624
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sharon English, MD
Address 0 0
Urology Associates
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

Summary results
Other publications