UCon Treatment of the Symptoms of Faecal Incontinence (FI)

Launched by INNOCON MEDICAL · May 9, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new medical device called UCon, which aims to help people who experience fecal incontinence (FI) and fecal urgency. The device works by sending gentle electrical signals through the skin to help control the muscles that manage bowel activity, potentially reducing unwanted bowel movements and improving the quality of life for those affected. The trial is currently recruiting participants aged 18 and older who have symptoms of fecal incontinence and can provide feedback and follow instructions, including using the device at home.

Participants in this study can expect to try the UCon device and share their experiences regarding its effectiveness and ease of use. However, some individuals may not be eligible to participate, such as those with certain medical conditions, active infections, or who are pregnant. It is important for potential participants to discuss their health history with the study team to determine if they qualify. Overall, this trial aims to gather information on how well the UCon device works to manage symptoms of fecal incontinence and improve patients' daily lives.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Participant is ≥ 18 years of age.
• • 2. Participant is showing symptoms of FI.
• • 3. 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:
• • 1. Participant is medically unstable (acute illness or complication of a chronic condition that might affect the participants´ participation in the investigation).
• • 2. Participant has an active infection in the genital area.
• • 3. 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).
• • 4. 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.
• • 5. 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.
• • 6. 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.
• • 7. Participant is currently receiving cancer treatment.
• • 8. Participant has addictive behaviour defined as abuse of alcohol, cannabis, opioids, or other intoxicating drugs.
• • 9. Participant does not speak and understand Spanish.
• • The following contraception is considered effective: Intrauterine device, hormonal contraceptives such as birth control pills, implants, contraceptive patch, vaginal ring, and contraceptive injection.