Safety and Performance of UCon Patch Electrode

Recruiting now · Not applicable · Has a placebo group

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

In brief

UCon is a medical device for treating the symptoms of overactive bladder (OAB) and bowel dysfunction (BD). It electrically stimulates the DGN through the skin to obtain modulated behavior of the bladder/bowel musculature e.g., suppressing undesired bladder/bowel activity to relieve the symptoms of the patient. This pivotal clinical investigation is designed as a stratified-randomized, single-blinded, controlled, confirmatory, prospective, multicenter clinical investigation.

Key facts

Study ID

NCT06754189

Run by

InnoCon Medical

People needed

180

Starts

2025-03-20

Expected to finish

2028-03-20

Last updated by the study team

2025-03-27

Who can join

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

You may qualify if…

• Participant is ≥ 18 years of age.
• Participant is diagnosed with OAB or BD.
• Participant is able to consent, communicate, provide feedback, and understand and follow instructions in Danish during the course of the investigation, including operation of the device at home.

You may not qualify if…

• Participant has genital anatomy that does not allow for proper electrode placement or stimulation of the DGN.
• Participant has an active infection in the genital area, including skin infections.
• Participant has injured or irritated skin in the genital area, where the electrode is placed.
• Participant is medically unstable (acute illness or complication of a chronic condition, apart from the OAB or BD, that might affect the participant's participation in the investigation).
• 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, planning a pregnancy (to be confirmed with a negative pregnancy test) or has given birth within the previous 12 months. Women of childbearing potential must maintain effective contraception* during the clinical investigation.
• Participant is enrolled or planning to enroll in another conflicting clinical investigation or was enrolled in an investigational drug trial within the previous 12 weeks or medical device investigation within 12 weeks of enrolment.
• Participant has previously participated in a clinical investigation with UCon.
• Participant has failed (lack of effectiveness) other neuromodulation treatments, e.g. sacral neuromodulation (SNM) within the previous 2 years.
• Participant has a neurological disease, e.g., chronic inflammatory demyelinating polyneuropathy, multiple sclerosis, stroke, central nervous system (CNS) tumors, Parkinson´s, spinal cord injury, diabetic neuropathy, Guillain-Barré syndrome.
• Participant has a history of cancer in the pelvic region, is currently receiving cancer treatment, or has received radiation therapy in the pelvic region.
• Participant had surgery in the pelvic region within the previous 6 months. If it can be excluded that the participant's symptoms are related to the surgery, they can be included in the clinical investigation.
• Participant has addictive behavior defined as the abuse of alcohol, cannabis, opioids, or other intoxicating drugs.
• The following contraception is considered effective: Intrauterine device, hormonal contraceptives such as birth control pills, implants, contraceptive patch, vaginal ring, and contraceptive injection.
• Exclusion Criteria specific for OAB:
• Participant is planning or has a scheduled surgery/diagnostic procedure (within the duration of their participation) for any condition, that would require catheterization. Or have a prolonged hospitalization that would affect the ability to complete the stimulation.
• Participant (male) has symptoms of bladder outlet obstruction, e.g., caused by benign prostatic hyperplasia or prostate cancer.
• Participant has polyuria or symptoms of polyuria.
• Participant has a current or reoccurring urinary tract infection (≥3 or more within the previous 12 months or ≥2 within the previous 6 months).
• Participant has a primary diagnosis of stress urinary incontinence (SUI) or mixed incontinence with SUI likely to confound outcome measures.
• Participant has Bladder Pain Syndrome or interstitial cystitis.
• Participant has had botulinum toxin (BOTOX) treatment in the pelvic region within 9 months or has lasting benefit from BOTOX.
• Participant has failed (lack of effectiveness) BOTOX treatment within the previous 2 years.
• Participants who demonstrate detrusor overactivity on a urodynamic test can be included.
• Participant has used antimuscarinics or β3 agonists within 2 weeks.

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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