18 and older, any sex, with 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 in UUI Episodes Per DayPrimary· 3 months post-activation
The primary endpoint is to explore the effect of two different eCoin amplitude settings on the change of UUI episodes per day on a 3-day voiding diary.
A negative number shows a reduction in UUI episodes per day which means symptoms have improved since baseline.
A positive number shows an increase in UUI episodes per day which means symptoms have worsened since baseline.
Group
Value
95% CI
Sensory
-2.1
± 2.42
Subsensory
-2.73
± 1.8
Change in UUI Episodes Per DaySecondary· 2 months post-activation
Change in the number of urgency urinary incontinence episodes per day on a 3-day voiding diary.
A negative number shows a reduction in UUI episodes which means symptoms have improved since baseline.
A positive number shows an increase in UUI episodes per day which means symptoms have worsened since baseline.
Group
Value
95% CI
Sensory
-2.75
± 1.9
Subsensory
-2.14
± 2.58
Change in UUI Episodes Per DaySecondary· 4 months post-activation
A secondary endpoint is to explore the change in UUI episodes per day on a 3-day voiding diary.
A negative number shows a reduction in UUI episodes per day which means symptoms have improved since baseline.
A positive number shows an increase in UUI episodes per day which means symptoms have worsened since baseline.
Group
Value
95% CI
Sensory
-2.59
± 2.6
Subsensory
-2.96
± 2.12
Change in Overactive Bladder Health Related Quality of Life (HRQL)Secondary· 2 and 3 months post-activation
Change from baseline in the patient reported quality of life as assessed by the Health Related Quality of Life (HRQL) portion of the Overactive Bladder questionnaire (OABq) survey.
Higher scores on the HRQL portion indicate better quality of life. The maximum HRQL domain score is 100 (best) and the minimum HRQL score is 0 (worst).
A positive change in score indicates an improvement in quality of life.
2 months
Group
Value
95% CI
Sensory
25.87
± 21.6
Subsensory
22.78
± 24.19
3-months
Group
Value
95% CI
Sensory
18.15
± 22.63
Subsensory
22.59
± 24.95
Change in Overactive Bladder Health Related Quality of Life (HRQL)Secondary· 4 months post-activation
Change from baseline in patient reported quality of life as assessed by the Health Related Quality of Life (HRQL) portion of the Overactive Bladder questionnaire (OABq) survey.
Higher scores on the HRQL indicate better quality of life. The maximum HRQL domain score is 100 (best) and the minimum HRQL score is 0 (worst).
A positive change in score indicates an improvement in quality of life.
Group
Value
95% CI
Sensory
22.03
± 25.56
Subsensory
32.09
± 26.2
Adverse events — posted to ClinicalTrials.gov
Time frame: 4 months post-activation.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Sensory
Serious: 0/18 (0%)
Deaths: 0/18
Subsensory
Serious: 0/18 (0%)
Deaths: 0/18
Other adverse events (16 terms — click to expand)
Reaction
System
Sensory
Subsensory
Incision Site Impaired Healing
Injury, poisoning and procedural complications
—
—
Site Incision Pain
Injury, poisoning and procedural complications
—
—
Medical Device Site Erythema
General disorders
—
—
Post Procedural Discomfort
General disorders
—
—
Incision Site Discharge
Injury, poisoning and procedural complications
—
—
Implant Site Oedema
Injury, poisoning and procedural complications
—
—
Incision Site Haemorrhage
Injury, poisoning and procedural complications
—
—
Incision Site Cellulitis, Medical Device Site Cellulitis
The goal of this prospective, multi-center, double-blinded randomized controlled is to learn about effectiveness and QOL with eCoin at two different amplitude settings in subjects with urge urinary incontincence (UUI). The main question it aims to answer is:
* The reduction in UUI episodes per day on a 3-day voiding diary in both groups after 3 months of therapy
Participants will be implanted with the eCoin device and randomized to either a sensory or subsensory stimulation group and complete voiding diaries and patient reported-outcomes through 3 months of therapy. After 3 months, subjects will be unblinded and reprogramming will be offered. Subjects will be followed for an additional month to a total of 4 months.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Valencia Technologies Corporation
Last refreshed: 3 November 2025
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/NCT05882318.