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NCT03556891

Pivotal Study of eCoin for Overactive Bladder With Urgency Urinary Incontinence

Completed NA Results posted Last updated 2 October 2025
What this trial tests

NA trial testing eCoin Tibial Nerve Stimulation in Overactive Bladder in 133 participants. Completed in 18 September 2024.

Timeline
4 September 2018
Primary endpoint
12 April 2020
18 September 2024

Quick facts

Lead sponsorValencia Technologies Corporation
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment133
Start date4 September 2018
Primary completion12 April 2020
Estimated completion18 September 2024
Sites15 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Valencia Technologies Corporation

Who can join

Adults 18 to 80, any sex, with Overactive Bladder or Urge Incontinence. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary. Primary · 48 weeks after device activation.

Responder rate

GroupValue95% CI
eCoin Tibial Nerve Stimulation6860 – 76
Long-term Safety in All Patients. Percentage of Patients With Device Related Adverse Events. Primary · 52 weeks after implantation.

All adverse events will be reported in all patients up to 52 weeks after implantation.

GroupValue95% CI
eCoin Tibial Nerve Stimulation16
Moderate-term Safety in All Patients. Percentage of Patients With Device Related Adverse Events. Secondary · 28 weeks after implantation

All adverse events will be reported.

GroupValue95% CI
eCoin Tibial Nerve Stimulation14
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. Secondary · 24 weeks after device activation

Moderate-term effectiveness data, responder rate

GroupValue95% CI
eCoin Tibial Nerve Stimulation6961 – 77
Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary Secondary · 96 weeks after device activation.

Responder rate

GroupValue95% CI
eCoin Tibial Nerve Stimulation7867 – 87
Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary. Secondary · 144 weeks after device activation

Responder rate

GroupValue95% CI
eCoin Tibial Nerve Stimulation7457 – 87
Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary. Secondary · 205 weeks after device activation

Responder rate

GroupValue95% CI
eCoin Tibial Nerve Stimulation6139 – 80
Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary. Secondary · 257 weeks after device activation

Responder rate

GroupValue95% CI
eCoin Tibial Nerve Stimulation6743 – 85
Long-term Safety in All Patients: Percentage of Patients With Device Related Adverse Events. Secondary · 96 weeks after implantation

All adverse events will be reported in all patients up to 96 weeks after implantation.

GroupValue95% CI
eCoin Tibial Nerve Stimulation20
Long-term Safety in All Patients: Percentage of Patients With Device Related Adverse Events Secondary · 144 weeks after implantation

All adverse events will be reported in all patients up to 144 weeks after implantation.

GroupValue95% CI
eCoin Tibial Nerve Stimulation20
Long-term Safety in All Patients. Percentage of Patients With Device Related Adverse Events Secondary · 205 weeks after implantation

All adverse events will be reported in all patients up to 205 weeks after implantation.

GroupValue95% CI
eCoin Tibial Nerve Stimulation21
Long-term Safety in All Patients. Percentage of Patients With Device Related Adverse Events Secondary · 257 weeks after implantation

All adverse events will be reported in all patients up to 257 weeks after implantation.

GroupValue95% CI
eCoin Tibial Nerve Stimulation23

Adverse events — posted to ClinicalTrials.gov

Time frame: 257 weeks post-implantation. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

eCoin Tibial Nerve Stimulation
Serious: 4/133 (3%)
Deaths: 2/133

Serious adverse events (3 terms)

ReactionSystemeCoin Tibial Nerve Stimula…
Implant site infectionInfections and infestations—
Postoperative wound infectionInfections and infestations—
Contact DermatitisSkin and subcutaneous tissue disorders—
Other adverse events (15 terms — click to expand)

ReactionSystemeCoin Tibial Nerve Stimula…
Postoperative wound infectionInfections and infestations—
Device stimulation issueProduct Issues—
Incision site painInjury, poisoning and procedural complications—
Device dislocationProduct Issues—
Wound dehiscenceInjury, poisoning and procedural complications—
Pain in extremityMusculoskeletal and connective tissue disorders—
Device malfunctionProduct Issues—
Incision site erythemaInjury, poisoning and procedural complications—
Implant site swellingGeneral disorders—
Skin irritationSkin and subcutaneous tissue disorders—
Wound abcessInfections and infestations—
WoundInjury, poisoning and procedural complications—
Medical device site discomfortGeneral disorders—
Muscoskeletal discomfortMusculoskeletal and connective tissue disorders—
Anal incontinenceGastrointestinal disorders—

Most-reported serious reactions: Implant site infection, Postoperative wound infection, Contact Dermatitis.

Data from ClinicalTrials.gov NCT03556891 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Emerging Implantable Tibial Nerve Stimulation Devices for Overactive Bladder.
    Nyan TH, Park E. · · 2025 · PMID 41077787 · DOI 10.5213/inj.2550162.081

Verify or expand the search:

Other trials of eCoin Tibial Nerve Stimulation

Trials testing the same drug.

Other recruiting trials for Overactive Bladder

Currently open trials in the same condition.

Other Valencia Technologies Corporation trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03556891.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing