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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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 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.