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OpenTrials
Completed

NCT Number: NCT03655054

eCoin for OAB Feasibility Follow-on Study

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).

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Key information

Conditions

Overactive Bladder Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Incontinence, Urinary Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urge Incontinence Urinary Bladder Diseases Urinary Bladder, Overactive Urinary Incontinence Urinary Incontinence, Urge Urinary Urge Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Urology Associates, Christchurch, New Zealand

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individual participated in the eCoin Feasibility Study for Urgency Urinary Incontinence.
  • Individual was implanted with the study device during the eCoin Feasibility Study for Urgency Urinary Incontinence.

Exclusion criteria

  • In the opinion of the investigator, individual is not a good candidate for participation in the study.

Treatment and study plan

eCoin Tibial Nerve Stimulation

Device

Subcutaneous stimulation of the tibial nerve using the eCoin device.

Primary outcomes

  1. Change From Baseline in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary.

    Time frame: 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.

    Time frame: 16 weeks after device implantation.

    Instances of a related adverse event.

Secondary outcomes

  1. Change From Baseline in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary.

    Time frame: 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.

    Time frame: 28 weeks after device implantation.

    Instances of a related adverse event

Sponsors and collaborators

Lead sponsor

Valencia Technologies Corporation

Industry

Registry information

Official study title

SUBCUTANEOUS TIBIAL NERVE STIMULATION FOR URGENCY URINARY INCONTINENCE: A FOLLOW-ON STUDY

Important dates

Study start
2019
Primary completion
2020
Study completion
2022
First posted
Aug 31, 2018
Registry last updated
Oct 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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