NCT03655054

eCoin for OAB Feasibility Follow-on Study

Completed NA Results posted Last updated 17 October 2022

What this trial tests

NA trial testing eCoin Tibial Nerve Stimulation in Overactive Bladder in 23 participants. Completed in 12 September 2022.

Timeline

13 March 2019

Primary endpoint
31 January 2020

12 September 2022

Quick facts

Lead sponsor	Valencia Technologies Corporation
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	23
Start date	13 March 2019
Primary completion	31 January 2020
Estimated completion	12 September 2022
Sites	7 locations across New Zealand, United States

Drugs / interventions tested

• eCoin Tibial Nerve Stimulation

Conditions studied

• Overactive Bladder — all drugs for Overactive Bladder →
• Urge Incontinence — all drugs for Urge Incontinence →
• Incontinence, Urinary — all drugs for Incontinence, Urinary →
• Urinary Urge Incontinence — all drugs for Urinary Urge Incontinence →

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.

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

Group	Value	95% CI
eCoin Tibial Nerve Stimulation	-2.2	± 3.3

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

Instances of a related adverse event.

Group	Value	95% CI
eCoin Tibial Nerve Stimulation	8

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

Group	Value	95% CI
eCoin Tibial Nerve Stimulation	-3.7	± 1.2

Safety in All Patients. All Adverse Events Will be Reported in All Patients Who Were Implanted 6 Months After Implantation. Secondary · 28 weeks after device implantation.

Instances of a related adverse event

Group	Value	95% CI
eCoin Tibial Nerve Stimulation	8

Adverse events — posted to ClinicalTrials.gov

Time frame: 28 weeks after 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: 0/23 (0%)

Deaths: 0/23

Other adverse events (4 terms — click to expand)

Reaction	System	eCoin Tibial Nerve Stimula…
Incision site discomfort	General disorders	—
Incision site swelling	General disorders	—
Incision site erythema	Skin and subcutaneous tissue disorders	—
Dermatitis	Skin and subcutaneous tissue disorders	—

Data from ClinicalTrials.gov NCT03655054 adverse events section.

Sponsor's own description

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).

Publications & conference data

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

1. Six-Month Outcomes of Reimplantation of a Coin-Sized Tibial Nerve Stimulator for the Treatment of Overactive Bladder Syndrome With Urgency Urinary Incontinence.
   Kaaki B, English S, Gilling P, Meffan P, et al · · 2022 · cited 4× · PMID 35536667 · DOI 10.1097/spv.0000000000001105