Safety and Performance of UCon Bar Electrode for the Treatment of Overactive Bladder (OAB) and Bo… (NCT06091566) | Clinical Trial Compass
RecruitingNot Applicable
Safety and Performance of UCon Bar Electrode for the Treatment of Overactive Bladder (OAB) and Bowel Dysfunction (BD)
Denmark20 participantsStarted 2024-01-12
Plain-language summary
UCon is a medical device for treatment of the symptoms of overactive bladder (OAB) and bowel dysfunction (BD). It electrically stimulates the 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.
This clinical investigation is designed as a single-arm, prospective, multi-centre, and early feasibility study.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. Participant is female
✓. Participant is ≥ 18 years of age.
✓. Participant is diagnosed with OAB or BD.
✓. Participant is able to communicate, provide feedback, understand and follow instructions during the course of the investigation, including using the device at home.
Exclusion criteria
✕. Participant is medically unstable (acute illness or complication of a chronic condition, apart from the OAB or BD, that might affect the participants´ participation in the investigation).
✕. Participant has an active infection in the genital area.
✕. Participant has an implanted pacemaker, implantable drug pump or other active medical devices (any medical device that uses electrical energy or other sources of power to make it function).
✕. Participant is pregnant, nursing or planning a pregnancy (to be confirmed with a negative pregnancy test). Women of childbearing potential must maintain effective contraception during the clinical investigation.
✕. Participant is enrolled or planning to enrol in another conflicting clinical investigation or was enrolled in an investigational drug trial or medical device investigation within four weeks of enrolment.
✕. Participant has neuropathy to a degree that is presumed to diminish the effect of the electrical stimulation.
✕
What they're measuring
1
PRIMARY SAFETY: ratio of participants with successful insertion of the UCon Bar Electrode.
Timeframe: After 4 weeks and 12 weeks
2
PRIMARY PERFORMANCE: ratio of treatment change [performance] of OAB/BD symptoms
Timeframe: Change from baseline at 4 weeks and/or 12 weeks
. Participant has a history of cancer in the pelvic region, are currently receiving cancer treatment, or has received radiation therapy in the pelvic region.
✕. Participant has addictive behaviour defined as the abuse of alcohol, cannabis, opioids, or other intoxicating drugs.