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New treatment option for Urinary Incontinence
Official title UCon Treatment of Overactive Bladder (OAB) in Males
ClinicalTrials.gov ID: NCT05874375
What this study is testing
- What it's testing
- UCon is a medical device for treatment of the symptoms of OAB and fecal incontinence (FI). It electrically stimulates the DGN through the skin to obtain modulated behaviour of the bladder musculature e.g., suppress undesired bladder activity to relieve the symptoms of the patient.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Subject is ≥ 18 years of age.
- Subject is male.
- Subject is diagnosed with OAB
- Subject is able to communicate, provide feedback, understand and follow instructions during the course of the investigation.
You likely can't join if
- Subject is medically unstable (acute illness or complications of a chronic condition that might affect the subject's participation in the...
- Subject has a Post Void Residual (PVR) of more than 100 ml or a Bladder Voiding Efficiency (BVE) of less than 75% (measured by uroflowmetry as the...
- Subject has an active infection in the genital area incl. skin infections and urinary tract infection.
- Subject has had botulinum toxin (BOTOX) treatment in the pelvic region within 6 months.
- Subject has used antimuscarinics or β3 agonists within 14 days weeks\ .
- Subject has an implanted pacemaker, implantable drug pump or other active medical device (any medical device that uses electrical energy or other...
See the full eligibility criteria
- Subject is ≥ 18 years of age.
- Subject is male.
- Subject is diagnosed with OAB
- Subject is able to communicate, provide feedback, understand and follow instructions during the course of the investigation.
- Subject is medically unstable (acute illness or complications of a chronic condition that might affect the subject's participation in the investigation).
- Subject has a Post Void Residual (PVR) of more than 100 ml or a Bladder Voiding Efficiency (BVE) of less than 75% (measured by uroflowmetry as the ratio of voided volume (VV) and total bladder capacity (VV+PVR)).
- Subject has an active infection in the genital area incl. skin infections and urinary tract infection.
- Subject has had botulinum toxin (BOTOX) treatment in the pelvic region within 6 months.
- Subject has used antimuscarinics or β3 agonists within 14 days weeks\ .
- 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 enrolled or planning to enrol in another clinical investigation or was enrolled in an investigational drug study or medical device investigation 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 alcohol, cannabis, opioids, or other intoxicating drugs.
- Subject does not speak and understand Dutch.
- If a subject is currently being treated with antimuscarinics or β3 agonists, he is allowed to be included in the investigation, however, a washout period of 14 days is required before baseline can be established.
The study team makes the final eligibility decision.
Where it's taking place
- Maastricht, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Maastricht, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.