Overactive BladderNCT03556891

Pivotal Study of eCoin for Overactive Bladder With Urgency Urinary Incontinence

A study testing eCoin Tibial Nerve Stimulation in people with Overactive Bladder and Urge Incontinence, run by Valencia Technologies Corporation at 15 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Overactive Bladder, Urge Incontinence, Incontinence, Urinary
What is being tested?: eCoin Tibial Nerve Stimulation
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 133 participants
Where: 15 sitesUnited States
Study dates: 4 Sep 2018to 18 Sep 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Primary Inclusion Criteria:

Women and men between 18 and 80 years old.
Diagnosis of overactive bladder with urgency urinary incontinence or mixed urge and stress incontinence with a predominant urgency component (selfreported), for at least 6 months.
Individual is without pharmacological treatment of overactive bladder (antimuscarinics and beta-3 agonists).
Individual is intolerant of or has an inadequate response to any of anticholinergics, β3-adrenoceptor agonists, onabotulinumtoxinA, or percutaneous tibial nerve stimulation.

Primary Exclusion Criteria:

Predominant stress urinary incontinence with more than 1/3 stress urinary incontinent episodes when compared to total urinary incontinent episodes.
Clinically significant bladder outlet obstruction.
Clinically significant pelvic organ prolapse beyond the hymenal ring.
Inadequate skin integrity or any evidence of an infection or inflammation in either lower leg.

Trial locations and contacts

15 sites in 1 country.

City, postcode or hospital

15 sites in 1 country

United States15 sites

The Institute for Female Pelvic Medicine & Reconstructive Surgery (FPM Institute)
Allentown, Pennsylvania, 18103
South Carolina OB/GYN
Columbia, South Carolina, 29201
Kaiser Permanente
Downey, California, 90242
SurgOne PC
Englewood, Colorado, 80113
Alliance Urology Specialists
Greensboro, North Carolina, 27403
Florida Bladder Institute
Naples, Florida, 34109
Manhattan Medical Research
New York, New York, 10016
Urology Associates of Norwalk
Norwalk, Connecticut, 06850
Adult & Pediatric Urology
Omaha, Nebraska, 68114
Chesapeake Urology
Owings Mills, Maryland, 21117
Sequoia Urology Center
Redwood City, California, 94062
Kaiser Permanente
San Diego, California, 92110
Sansum Clinic
Santa Barbara, California, 93105
North Shore Medical Group
Skokie, Illinois, 60076
UnityPoint Clinic
Waterloo, Iowa, 50703

Other trials in United States

About this study

Official title: Pivotal Study of Subcutaneous Tibial Nerve Stimulation With eCoin for Overactive Bladder (OAB) With Urgency Urinary Incontinence (UUI)

This trial is a prospective, multicenter, single-arm study of the safety and effectiveness of eCoinTM tibial nerve stimulation in subjects having overactive bladder (OAB) with urgency urinary incontinence (UUI). The study will evaluate changes from baseline in OAB symptoms as measured by voiding diaries and patient reported-outcomes through 48 weeks of eCoinTM therapy or 52 weeks of implantation.

Read the detailed description

This study enrolled and implanted 133 subjects at 15 sites in the US under the original IDE.

Subjects were given the option to extend out to 3 years post activation, with annual visits at 2 and 3 years post activation (96 and 144 weeks post-activation).

Subjects who are still active in the original IDE study will be offered consecutive enrollment in the post approval study and will be given the option to receive a new implant. Subjects who are no longer active, or have exited the study will be given the option to reenter the study and complete two follow-up visits. Subjects re-entering the study will not have the option to receive a new implant. Post approval follow-up of subjects will occur through the year 5 visit (257 weeks post-activation of their original device). Reimplantation of a new eCoin would not reset their follow-up clock.

Conditions: Overactive Bladder, Urge Incontinence, Incontinence, Urinary, Urinary Urge Incontinence
Being tested: eCoin Tibial Nerve Stimulation
Medical subject headings: Urinary Bladder, Overactive, Urinary Incontinence, Urge, Urinary Incontinence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

eCoin Tibial Nerve StimulationDevice
Subcutaneous stimulation of the tibial nerve using the eCoin device.

Study groups in NCT03556891
Study group	Role	What they receive
eCoin Tibial Nerve Stimulation	Experimental	Not described Receives: Device: eCoin Tibial Nerve Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary.
Responder rate
Measured: 48 weeks after device activation.
Long-term Safety in All Patients. Percentage of Patients With Device Related Adverse Events.
All adverse events will be reported in all patients up to 52 weeks after implantation.
Measured: 52 weeks after implantation.

Secondary outcomes (10)

Moderate-term Safety in All Patients. Percentage of Patients With Device Related Adverse Events.
All adverse events will be reported.
Measured: 28 weeks after implantation
Moderate-term Effectiveness Data. Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary.
Moderate-term effectiveness data, responder rate
Measured: 24 weeks after device activation
Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary
Responder rate
Measured: 96 weeks after device activation.
Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary.
Responder rate
Measured: 144 weeks after device activation
Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary.
Responder rate
Measured: 205 weeks after device activation
Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary.
Responder rate
Measured: 257 weeks after device activation
Long-term Safety in All Patients: Percentage of Patients With Device Related Adverse Events.
All adverse events will be reported in all patients up to 96 weeks after implantation.
Measured: 96 weeks after implantation
Long-term Safety in All Patients: Percentage of Patients With Device Related Adverse Events
All adverse events will be reported in all patients up to 144 weeks after implantation.
Measured: 144 weeks after implantation
Long-term Safety in All Patients. Percentage of Patients With Device Related Adverse Events
All adverse events will be reported in all patients up to 205 weeks after implantation.
Measured: 205 weeks after implantation
Long-term Safety in All Patients. Percentage of Patients With Device Related Adverse Events
All adverse events will be reported in all patients up to 257 weeks after implantation.
Measured: 257 weeks after implantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Sep 201818 Sep 2024

First posted14 Jun 2018
Study start4 Sep 2018
Primary completion12 Apr 2020
Study completion18 Sep 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Overactive BladderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 133 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03556891
Sponsor's protocol ID: 111-3281
Status last verified: Sep 2025
First submitted: 22 May 2018
Last updated: 2 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Tensi+ European Post-Market Clinical Follow-Up
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Transcranial Direct Current Stimulation for Neurogenic Overactive Bladder Symptoms Among People With Stroke
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Parasacral TENS Project
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INTIBIA Pivotal Study
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A Real World Study of eCoin for Urgency Urinary Incontinence: Post Approval Evaluation (RECIPE)
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All Overactive Bladder trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pivotal Study of Subcutaneous Tibial Nerve Stimulation With eCoin for Overactive Bladder (OAB) With Urgency Urinary Incontinence (UUI)
ClinicalTrials.gov ID: NCT03556891
Acronym / sponsor ID: 111-3281
Conditions: Overactive Bladder, Urge Incontinence, Incontinence, Urinary, Urinary Urge Incontinence
Study type: Interventional
Recruitment status: Completed
Enrolment: 133 participants (actual)
Lead sponsor: Valencia Technologies CorporationIndustry (pharma, biotech, devices)
Study start: 4 Sep 2018 (actual)
Primary completion: 12 Apr 2020 (actual)
Study completion: 18 Sep 2024 (actual)
First posted: 14 Jun 2018 (actual)
Results: Posted 30 Jul 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

This study enrolled and implanted 133 subjects at 15 sites in the US under the original IDE.

Subjects were given the option to extend out to 3 years post activation, with annual visits at 2 and 3 years post activation (96 and 144 weeks post-activation).

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
eCoin Tibial Nerve Stimulation	Experimental	Device: eCoin Tibial Nerve Stimulation

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
eCoin Tibial Nerve StimulationSubcutaneous stimulation of the tibial nerve using the eCoin device.	Device	eCoin Tibial Nerve Stimulation

Primary outcome

Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary.
Time frame: 48 weeks after device activation.
Responder rate
Long-term Safety in All Patients. Percentage of Patients With Device Related Adverse Events.
Time frame: 52 weeks after implantation.
All adverse events will be reported in all patients up to 52 weeks after implantation.

10 secondary outcomes

Moderate-term Safety in All Patients. Percentage of Patients With Device Related Adverse Events.
Time frame: 28 weeks after implantation
Moderate-term Effectiveness Data. Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary.
Time frame: 24 weeks after device activation
Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary
Time frame: 96 weeks after device activation.
Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary.
Time frame: 144 weeks after device activation
Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary.
Time frame: 205 weeks after device activation
Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary.
Time frame: 257 weeks after device activation
Long-term Safety in All Patients: Percentage of Patients With Device Related Adverse Events.
Time frame: 96 weeks after implantation
Long-term Safety in All Patients: Percentage of Patients With Device Related Adverse Events
Time frame: 144 weeks after implantation
Long-term Safety in All Patients. Percentage of Patients With Device Related Adverse Events
Time frame: 205 weeks after implantation
Long-term Safety in All Patients. Percentage of Patients With Device Related Adverse Events
Time frame: 257 weeks after implantation

Results and safety

Results posted to the registry on 30 Jul 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
eCoin Tibial Nerve Stimulation	133	120

Primary outcome: Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary.

Time frame: 48 weeks after device activation.. Number (95% Confidence Interval). Unit: percentage of participants

Measure	eCoin Tibial Nerve Stimulation n = 133
Value	68 (60 to 76)

Population analysed: Intent to Treat

Primary outcome: Long-term Safety in All Patients. Percentage of Patients With Device Related Adverse Events.

Time frame: 52 weeks after implantation.. Number. Unit: percentage of participants

Measure	eCoin Tibial Nerve Stimulation n = 133
Value	16

Population analysed: Intent to Treat plus subject with a baseline UUI of 0.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: 257 weeks post-implantation. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
eCoin Tibial Nerve Stimulation	4 of 133 (3%)	40 of 133 (30.1%)	2 of 133

Limitations and caveats (from the sponsor): A limitation of the study was the lack of blinding and comparison. Considering that neuromodulation studies are generally not blinded since the therapy itself is sensed, a control group with a similar safety profile to eCoin could not be achieved. We also acknowledge that a 12-month endpoint provides only medium-term data on the durability of response and future longer follow up data will be needed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Overactive Bladder

RecruitingObservational study
Tensi+ European Post-Market Clinical Follow-Up
Overactive Bladder
Not yet recruiting
Transcranial Direct Current Stimulation for Neurogenic Overactive Bladder Symptoms Among People With Stroke
Stroke, Neurogenic Overactive Bladder
Not yet recruiting
Parasacral TENS Project
Overactive Bladder (OAB), Lower Urinary Tract Dysfunction
Active, not recruiting
INTIBIA Pivotal Study
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Recruiting
A Real World Study of eCoin for Urgency Urinary Incontinence: Post Approval Evaluation (RECIPE)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Scott MacDiarmid, MD principal investigator

Alliance Urology

15 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing eCoin Tibial Nerve Stimulation in people with Overactive Bladder and Urge Incontinence, run by Valencia Technologies Corporation at 15 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary. (time frame: 48 weeks after device activation.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03556891.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.