NCT03655054

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 Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

Longer than P75 for not_applicable

Geographic Reach
2 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

March 13, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

April 26, 2021

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2022

Completed
Last Updated

October 17, 2022

Status Verified

October 1, 2022

Enrollment Period

11 months

First QC Date

August 29, 2018

Results QC Date

March 29, 2021

Last Update Submit

October 11, 2022

Conditions

Overactive BladderUrge IncontinenceIncontinence, UrinaryUrinary Urge Incontinence

Outcome Measures

Primary Outcomes (2)

  • Change From Baseline in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary.

    12 weeks after device activation.

  • Safety in All Patients. All Adverse Events Will be Reported in All Patients Who Were Implanted 4 Months After Implantation.

    Instances of a related adverse event.

    16 weeks after device implantation.

Secondary Outcomes (2)

  • Change From Baseline in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary.

    24 weeks after device activation.

  • Safety in All Patients. All Adverse Events Will be Reported in All Patients Who Were Implanted 6 Months After Implantation.

    28 weeks after device implantation.

Study Arms (1)

eCoin Tibial Nerve Stimulation

EXPERIMENTAL
Device: eCoin Tibial Nerve Stimulation

Interventions

eCoin Tibial Nerve StimulationDEVICE

Subcutaneous stimulation of the tibial nerve using the eCoin device.

eCoin Tibial Nerve Stimulation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individual participated in the eCoin Feasibility Study for Urgency Urinary Incontinence.
  • Individual was implanted with the study device during the eCoin Feasibility Study for Urgency Urinary Incontinence.

You may not qualify if:

  • \. In the opinion of the investigator, individual is not a good candidate for participation in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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: 35536667DERIVED

MeSH Terms

Conditions

Urinary Bladder, OveractiveUrinary Incontinence, UrgeUrinary Incontinence

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsUrination Disorders

Results Point of Contact

Title
Jacqueline Dister
Organization
Valencia Technologies
jdister@valenciatechnologies.com
7604294787

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

August 29, 2018

First Posted

August 31, 2018

Study Start

March 13, 2019

Primary Completion

January 31, 2020

Study Completion

September 12, 2022

Last Updated

October 17, 2022

Results First Posted

April 26, 2021

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

US(4)NZ(3)