eCoin Tibial Nerve Stimulation for OAB

NCT03029624 | Completed Results DMC FDA Device

• 1 other identifier: 111-3175
• Study Type: interventional
• Target: 46
• Locations: 2 countries
• Sites: 7

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.

Conditions

Urgency Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• Incontinent Episodes

  The change in number of incontinence episodes from baseline to three months post-activation.

  Baseline to three months post-activation.

Secondary Outcomes (3)

• System and Procedure Related AEs

  Implantation to one month post-implantation.

• MAEs

  Baseline to 3 months post-activation.

• Percentage of Responders

  3 months after activation

Study Arms (1)

Treatment Arm

EXPERIMENTAL

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

Device: eCoin

Interventions

eCoin DEVICE

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

Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women and men 18 years and older.
• 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).
• Individual has at least four urgency incontinence episodes on a three-day voiding diary with at least one episode per 24 hour time period
• 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)
• Individual is unresponsive to, inadequately responsive to, or intolerant of behavioral, rehabilitation, and pharmacologic therapy.
• Individual is able to give his or her written, informed consent.
• Individual is mentally competent and able to understand all study requirements.
• Individual is willing and able to complete a 3-day voiding diary and quality of life questionnaire.
• Individual is without pharmacological treatment of overactive bladder (antimuscarinics and beta-3 agonists) for 2 weeks prior to screening.
• The individual demonstrates a positive nerve integrity test.

You may not qualify if:

• Individual has predominantly stress urinary incontinence
• Individual has clinically significant bladder outlet obstruction.
• Individual has clinically significant pelvic organ prolapse.
• Individual has abnormal post void residual (i.e., greater than 150 cc).
• Individual has clinically significant urethral stricture disease or bladder neck contracture
• Individual has an active urinary tract infection at time of enrollment.
• Individual has recurrent urinary tract infections defined as 4 or more UTI's per year.
• Individual has morbid obesity.
• Individual has had positive urine cytology or diagnosis of bladder or prostate cancer.
• Individual has neurogenic bladder dysfunction.
• Individual is taking an alpha-blocker for benign prostatic hyperplasia.
• Individual is pregnant or intends to become pregnant during the study.
• Patient is breast feeding or is less than 9-month post-partum.
• Individual has the presence of urinary fistula, bladder stone, or interstitial cystitis.
• Individual has uncontrolled diabetes mellitus.

Sponsors & Collaborators

• Valencia Technologies Corporation: lead

Study Sites (7)

The Clark Center for Urogynecology

Newport Beach, California, 92663, United States

Location

UnityPoint Clinic

Waterloo, Iowa, 50703, United States

Location

Alliance Urology Specialists

Greensboro, North Carolina, 27403, United States

Location

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

Allentown, Pennsylvania, 18103, United States

Location

Urology Associates

Christchurch, 8013, New Zealand

Location

Roundhay Medical Centre

Nelson, New Zealand

Location

Tauranga Urology Research Ltd

Tauranga, New Zealand

Location

Related Publications (1)

• 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.

  PMID: 35536667 DERIVED

Limitations and Caveats

This was a small study with a nonrandomized design and no control group. Studies in larger populations may clarify the factors associated with responders. The initial study period was short at only 3 months, and should be investigated further for durability.

Results Point of Contact

• Title: Stacy Chambliss, Chief of Clinical Trials
• Organization: Valencia Technologies

schambliss@valenciatechnologies.com

661-775-1414

Study Officials

• Sharon English, MD

  Urology Associates

  PRINCIPAL INVESTIGATOR

• Scott MacDiarmid, MD

  Alliance Urology Specialists

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2017
• First Posted: January 24, 2017
• Study Start: April 3, 2017
• Primary Completion: December 30, 2017
• Study Completion: October 1, 2018
• Last Updated: December 22, 2020
• Results First Posted: November 27, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (4); NZ (3)