eCoin for OAB Feasibility Follow-on Study

• Sponsor: Valencia Technologies Corporation (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03655054
• Collaborator: (none)
• Enrollment: 23
• Locations: 7
• Arm: 1
• Anticipated Duration (Months): 41.6
• Patients Per Site: 3.3
• Patients Per Site Per Month: 0.1

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Overactive Bladder; Urge Incontinence; Incontinence, Urinary; Urinary Urge Incontinence	Device: eCoin Tibial Nerve Stimulation	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 23 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: SUBCUTANEOUS TIBIAL NERVE STIMULATION FOR URGENCY URINARY INCONTINENCE: A FOLLOW-ON STUDY
• Actual Study Start Date: Mar 13, 2019
• Actual Primary Completion Date: Jan 31, 2020
• Anticipated Study Completion Date: Aug 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: eCoin Tibial Nerve Stimulation	Device: eCoin Tibial Nerve Stimulation; Subcutaneous stimulation of the tibial nerve using the eCoin device.

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary. [12 weeks after device activation.]

2. Safety in All Patients. All Adverse Events Will be Reported in All Patients Who Were Implanted 4 Months After Implantation. [16 weeks after device implantation.]

   Instances of a related adverse event.

Secondary Outcome Measures

1. Change From Baseline in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary. [24 weeks after device activation.]

2. 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.]

   Instances of a related adverse event

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Clark Center for Urogynecology	Newport Beach	California	United States	92663
2	UnityPoint Clinic	Waterloo	Iowa	United States	50703
3	Alliance Urology Specialists	Greensboro	North Carolina	United States	27403
4	The Institute for Female Pelvic Medicine & Reconstructive Surgery (FPM Institute)	Allentown	Pennsylvania	United States	18103
5	Urology Associates	Christchurch		New Zealand	8013
6	Roundhay Medical Centre	Nelson		New Zealand
7	Tauranga Urology Research Ltd	Tauranga		New Zealand

Sponsors and Collaborators

• Valencia Technologies Corporation

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 13, 2019

More Information

Publications

None provided.

• Responsible Party: Valencia Technologies Corporation
• ClinicalTrials.gov Identifier: NCT03655054
• Other Study ID Numbers: 111-3335
• First Posted: Aug 31, 2018
• Last Update Posted: May 18, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Urinary Bladder, Overactive; Urinary Incontinence, Urge; Urinary Incontinence; Enuresis

Study Results

Participant Flow

Arm/Group Title	eCoin Tibial Nerve Stimulation
Arm/Group Description	eCoin Tibial Nerve Stimulation: Subcutaneous stimulation of the tibial nerve using the eCoin device.
Period Title: Overall Study
STARTED	23
COMPLETED	22
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	eCoin Tibial Nerve Stimulation
Arm/Group Description	eCoin Tibial Nerve Stimulation: Subcutaneous stimulation of the tibial nerve using the eCoin device.
Overall Participants	23
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	9 39.1%
>=65 years	14 60.9%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	63.6 (11.0)
Sex: Female, Male (Count of Participants)
Female	22 95.7%
Male	1 4.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	23 100%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	23 100%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
New Zealand	9 39.1%
United States	14 60.9%
Mean UUI Episodes/Day (episodes/day) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [episodes/day]	4.8 (3.2)

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary.
Time Frame	12 weeks after device activation.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	eCoin Tibial Nerve Stimulation
Arm/Group Description	eCoin Tibial Nerve Stimulation: Subcutaneous stimulation of the tibial nerve using the eCoin device.
Measure Participants	23
Mean (Standard Deviation) [episodes/day]	-2.2 (3.3)

2. Primary Outcome

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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	eCoin Tibial Nerve Stimulation
Arm/Group Description	eCoin Tibial Nerve Stimulation: Subcutaneous stimulation of the tibial nerve using the eCoin device.
Measure Participants	23
Number [adverse events]	8

3. Secondary Outcome

Title	Change From Baseline in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary.
Time Frame	24 weeks after device activation.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	eCoin Tibial Nerve Stimulation
Arm/Group Description	eCoin Tibial Nerve Stimulation: Subcutaneous stimulation of the tibial nerve using the eCoin device.
Measure Participants	22
Mean (Standard Deviation) [episodes/day]	-3.7 (1.2)

4. Secondary Outcome

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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	eCoin Tibial Nerve Stimulation
Arm/Group Description	eCoin Tibial Nerve Stimulation: Subcutaneous stimulation of the tibial nerve using the eCoin device.
Measure Participants	22
Number [adverse events]	8

Adverse Events

Time Frame	28 weeks after implantation
Arm/Group Title	eCoin Tibial Nerve Stimulation
Arm/Group Description	eCoin Tibial Nerve Stimulation: Subcutaneous stimulation of the tibial nerve using the eCoin device.
All Cause Mortality
	eCoin Tibial Nerve Stimulation
	Affected / at Risk (%)	# Events
Total	0/23 (0%)
Serious Adverse Events
	eCoin Tibial Nerve Stimulation
	Affected / at Risk (%)	# Events
Total	0/23 (0%)
Other (Not Including Serious) Adverse Events
	eCoin Tibial Nerve Stimulation
	Affected / at Risk (%)	# Events
Total	6/23 (26.1%)
General disorders
Incision site discomfort	3/23 (13%)	3
Incision site swelling	3/23 (13%)	3
Skin and subcutaneous tissue disorders
Incision site erythema	1/23 (4.3%)	1
Dermatitis	1/23 (4.3%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.