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

Recruiting now · Not applicable

Conditions studied: Urinary Incontinence, Urinary Incontinence, Urge, Fecal Incontinence, Fecal Incontinence With Fecal Urgency, Nocturia, Urinary Frequency More Than Once at Night, Bowel Disorders Functional, Incontinence, Nighttime Urinary

In brief

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.

Key facts

Study ID

NCT06091566

Run by

InnoCon Medical

People needed

20

Starts

2024-01-12

Expected to finish

2027-01-01

Last updated by the study team

2026-02-18

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Participant is female
• Participant is ≥ 18 years of age.
• 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).
• Participant is able to communicate, provide feedback, understand and follow instructions during the course of the investigation, including using the device at home.

You may not qualify if…

• 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.
• 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.
• 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.

Where it is running

• Aarhus University Hospital — Aarhus, Denmark (enrolling)
• Herlev Hospital — Herlev, Denmark (enrolling)
• Odense University Hospital — Odense, Denmark (enrolling)

Full record on ClinicalTrials.gov

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