Safety and Performance of UCon Bar Electrode for the Treatment of Overactive Bladder (OAB) and Bowel Dysfunction (BD)

Launched by INNOCON MEDICAL · Oct 16, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new medical device called UCon, which is designed to help women who experience overactive bladder (OAB) and bowel dysfunction (BD). The UCon device works by sending gentle electrical signals through the skin to help control bladder and bowel activity, aiming to reduce symptoms like frequent urination, urgency, and incontinence. The trial is currently recruiting female participants aged 18 and older who have been diagnosed with OAB or BD.

To be eligible, participants should be able to understand and follow instructions for using the device at home. However, certain health conditions may prevent participation, such as having an active infection or a pacemaker. Throughout the trial, participants will have the opportunity to provide feedback about their experiences using the UCon device. This study aims to gather important information about the safety and effectiveness of UCon, which could lead to better treatment options for women facing these challenges.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Participant is female
• • 2. Participant is ≥ 18 years of age.
• • 3. Participant is diagnosed with OAB or BD.
• OAB: Urinary urgency usually with one or more of the following:
• • i. Urinary urgency incontinence (≥1 per/week). ii. Urinary frequency (≥8 voiding/day without polyuria). iii. Nocturia (≥2 voiding/night without nocturnal polyuria).
• BD: One or more of the following:
• • i. Faecal urgency (≥3 urgencies pr. week) together with registration of urgency in St. Mark´s and a St. Mark´s score ≥9.
• • ii. Faecal incontinence (urge/passive) (≥1 per/week).
• • 4. 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, apart from the OAB or BD, 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 devices (any medical device that uses electrical energy or other sources 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 clinical investigation.
• • 5. 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.
• • 6. Participant has neuropathy to a degree that is presumed to diminish the effect of the electrical stimulation.
• • 7. Participant has a history of cancer in the pelvic region, are currently receiving cancer treatment, or has received radiation therapy in the pelvic region.
• • 8. Participant has addictive behaviour defined as the abuse of alcohol, cannabis, opioids, or other intoxicating drugs.
• • 9. Participant does not speak or understand Danish.
• • The following contraception is considered effective: Intrauterine device, hormonal contraceptives such as birth control pills, implants, contraceptive patch, vaginal ring, and contraceptive injection.