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eCoin Tibial Nerve Stimulation for OAB

NCT ID: NCT03029624

Last Updated: 2020-12-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-03

Study Completion Date

2018-10-01

Brief Summary

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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.

Detailed Description

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This trial is a single arm, prospective study of the safety and effectiveness of eCoin tibial nerve stimulation in 25 subjects with refractory overactive bladder as defined by the American Urological Association.. The eCoin neuromodulation device will be implanted subcutaneously in the right or left leg of patients with urgency urinary incontinence. After a 4 week implant healing period, subjects will have their devices activated (turned ON). After 3 months of device therapy (occurring 4 months post-implant), the primary endpoint will be assessed. It is anticipated that subjects will reach the full therapeutic effect at approximately 3 months of therapy. Subjects will be followed for an additional 9 months to assess the safety of maintenance stimulation therapy with fewer sessions occurring during this time interval.

Conditions

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Urgency Urinary Incontinence

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment Arm

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

Group Type EXPERIMENTAL

eCoin

Intervention Type DEVICE

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

Interventions

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eCoin

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

Intervention Type DEVICE

Eligibility Criteria

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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.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Valencia Technologies Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sharon English, MD

Role: PRINCIPAL_INVESTIGATOR

Urology Associates

Scott MacDiarmid, MD

Role: PRINCIPAL_INVESTIGATOR

Alliance Urology Specialists

Locations

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The Clark Center for Urogynecology

Newport Beach, California, United States

Site Status

UnityPoint Clinic

Waterloo, Iowa, United States

Site Status

Alliance Urology Specialists

Greensboro, North Carolina, United States

Site Status

The Institute for Female Pelvic Medicine & Reconstructive Surgery (FPM Institute)

Allentown, Pennsylvania, United States

Site Status

Urology Associates

Christchurch, , New Zealand

Site Status

Roundhay Medical Centre

Nelson, , New Zealand

Site Status

Tauranga Urology Research Ltd

Tauranga, , New Zealand

Site Status

Countries

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United States New Zealand

References

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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.

Reference Type DERIVED
PMID: 35536667 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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111-3175

Identifier Type: -

Identifier Source: org_study_id