Safety and Performance of UCon for the Treatment of the Symptoms of Overactive Bladder (OAB) / Bo… (NCT05368246) | Clinical Trial Compass
CompletedNot Applicable
Safety and Performance of UCon for the Treatment of the Symptoms of Overactive Bladder (OAB) / Bowel Dysfunction (BD)
Denmark80 participantsStarted 2022-02-15
Plain-language 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 performance in a small number of subjects. UCon is a medical device for treatment of the symptoms of overactive bladder (OAB) and bowel disorders (BD). It electrically stimulates the dorsal genital nerve (DGN) through the skin to obtain modulated behaviour of the bladder/bowel musculature e.g., suppress undesired bladder/bowel activity to relieve the symptoms of the patient.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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.
What they're measuring
1
Characterization of adverse events related to the risks and anticipated adverse device effects associated with the use of UCon.
Timeframe: After 4 and 12 weeks of stimulation (end of study).
2
Ratio of subjects with at least 50% improvement of their OAB/BD symptoms from baseline associated with the use of UCon.
Timeframe: Change from baseline OAB/BD symptoms at 4 and 12 weeks.
✕. 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.