UCon Treatment of the Symptoms of Faecal Incontinence (FI) (NCT05864807) | Clinical Trial Compass
CompletedNot Applicable
UCon Treatment of the Symptoms of Faecal Incontinence (FI)
Spain30 participantsStarted 2023-08-01
Plain-language summary
UCon is a medical device for treatment of the symptoms of overactive bladder and fecal incontinence (FI). 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, single-centre, early feasibility study.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Participant is ≥ 18 years of age.
✓. Participant is showing symptoms of FI.
✓. 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 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 device (any medical device that uses electrical energy or other source 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 interventional period judged by the investigator.
✕. Participant is enrolled or planning to enrol in another clinical investigation or was enrolled in an investigational drug trial or medical device investigation within four weeks to enrolment.
✕. Participant has neuropathy to a degree that is presumed to diminish the effect of the electrical stimulation, e.g., denervated patients and severe diabetic neuropathy.
✕. Participant is currently receiving cancer treatment.
What they're measuring
1
PRIMARY SAFETY: To evaluate adverse events [initial safety] of UCon for treatment of the symptoms of FI in a home setting.
Timeframe: After 28 days (4 weeks)
2
PRIMARY PERFORMANCE: To evaluate the ratio of treatment change [performance] of FI symptoms in a home setting.
Timeframe: Change from baseline at 28 days (4 weeks) and 42 days (6 weeks)