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eCoin for OAB Feasibility Follow-on Study

Primary Purpose

Overactive Bladder, Urge Incontinence, Incontinence, Urinary

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
eCoin Tibial Nerve Stimulation
Sponsored by
Valencia Technologies Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Exclusion Criteria:

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

Sites / Locations

  • The Clark Center for Urogynecology
  • UnityPoint Clinic
  • Alliance Urology Specialists
  • The Institute for Female Pelvic Medicine & Reconstructive Surgery (FPM Institute)
  • Urology Associates
  • Roundhay Medical Centre
  • Tauranga Urology Research Ltd

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

eCoin Tibial Nerve Stimulation

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change From Baseline in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary.
Safety in All Patients. All Adverse Events Will be Reported in All Patients Who Were Implanted 6 Months After Implantation.
Instances of a related adverse event

Full Information

First Posted
August 29, 2018
Last Updated
October 11, 2022
Sponsor
Valencia Technologies Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03655054
Brief Title
eCoin for OAB Feasibility Follow-on Study
Official Title
SUBCUTANEOUS TIBIAL NERVE STIMULATION FOR URGENCY URINARY INCONTINENCE: A FOLLOW-ON STUDY
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
March 13, 2019 (Actual)
Primary Completion Date
January 31, 2020 (Actual)
Study Completion Date
September 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Valencia Technologies Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder, Urge Incontinence, Incontinence, Urinary, Urinary Urge Incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
eCoin Tibial Nerve Stimulation
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
eCoin Tibial Nerve Stimulation
Intervention Description
Subcutaneous stimulation of the tibial nerve using the eCoin device.
Primary Outcome Measure Information:
Title
Change From Baseline in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary.
Time Frame
12 weeks after device activation.
Title
Safety in All Patients. All Adverse Events Will be Reported in All Patients Who Were Implanted 4 Months After Implantation.
Description
Instances of a related adverse event.
Time Frame
16 weeks after device implantation.
Secondary Outcome Measure Information:
Title
Change From Baseline in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary.
Time Frame
24 weeks after device activation.
Title
Safety in All Patients. All Adverse Events Will be Reported in All Patients Who Were Implanted 6 Months After Implantation.
Description
Instances of a related adverse event
Time Frame
28 weeks after device implantation.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 1. In the opinion of the investigator, individual is not a good candidate for participation in the study.
Facility Information:
Facility Name
The Clark Center for Urogynecology
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
UnityPoint Clinic
City
Waterloo
State/Province
Iowa
ZIP/Postal Code
50703
Country
United States
Facility Name
Alliance Urology Specialists
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
Facility Name
The Institute for Female Pelvic Medicine & Reconstructive Surgery (FPM Institute)
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Urology Associates
City
Christchurch
ZIP/Postal Code
8013
Country
New Zealand
Facility Name
Roundhay Medical Centre
City
Nelson
Country
New Zealand
Facility Name
Tauranga Urology Research Ltd
City
Tauranga
Country
New Zealand

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35536667
Citation
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.
Results Reference
derived

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eCoin for OAB Feasibility Follow-on Study

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