Status:
COMPLETED
Safety and Performance of UCon for the Treatment of the Symptoms of Overactive Bladder (OAB) / Bowel Dysfunction (BD)
Lead Sponsor:
InnoCon Medical
Collaborating Sponsors:
Aarhus University Hospital
Herlev Hospital
Conditions:
Urinary Incontinence
Fecal Incontinence
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This clinical investigation is a single-arm, prospective, multicentre, early feasibility study, which is used to evaluate the device design of UCon with respect to initial clinical safety and device p...
Detailed Description
The study is conducted at multiple hospitals in Denmark (Aarhus University Hospital, Odense University Hospital and Herlev Hospital). It is estimated that 20 subjects with OAB and 20 subjects with BD ...
Eligibility Criteria
Inclusion
- Subject is ≥ 18 years of age.
- Subject is diagnosed with OAB or BD.
- Subject is able to communicate, provide feedback, understand and follow instructions during the course of the study.
- Subject has signed an informed consent.
Exclusion
- Subject is medically unstable.
- Subject has an active infection in the genital area.
- Subject has an implanted pacemaker, implantable drug pump or other active medical device (any medical device that uses electrical energy or other source of power to make it function).
- Subject is pregnant, nursing or planning a pregnancy (to be confirmed with a negative pregnancy test within 14 days prior to enrolment). Women of childbearing potential must maintain effective contraception\* during the study period judged by the investigator.
- Subject is enrolled or planning to enrol in another investigational study or was enrolled in an investigational drug or medical device trial within four weeks to enrolment.
- Subject has neuropathy to a degree that is presumed to diminish the effect of the electrical stimulation.
- Subject has a history of cancer in the pelvic region, are currently receiving cancer treatment, or has radiation-induced damage to the pelvic region.
- Subject has addictive behaviour defined as abuse of cannabis, opioids, or other intoxicating drugs.
- Subject does not speak and understand Danish.
Key Trial Info
Start Date :
February 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 15 2024
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05368246
Start Date
February 15 2022
End Date
January 15 2024
Last Update
February 5 2024
Active Locations (3)
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1
Aarhus University Hospital
Aarhus, Aarhus N, Denmark, 8200
2
Herlev Hospital
Herlev, Region Sjælland, Denmark, 2730
3
Odense University Hospital
Odense, Denmark, 5000