Actively Recruiting
Safety and Performance of UCon Patch Electrode
Led by InnoCon Medical · Updated on 2025-03-27
180
Participants Needed
3
Research Sites
156 weeks
Total Duration
On this page
Sponsors
I
InnoCon Medical
Lead Sponsor
A
Aarhus University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Performance of UCon Patch Electrode
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant is 18 years of age or older.
- Participant is diagnosed with overactive bladder (OAB) or bowel dysfunction (BD).
- Participant is able to consent, communicate, provide feedback, and understand and follow instructions in Danish during the study, including operating the device at home.
You will not qualify if you...
- Genital anatomy does not allow for proper electrode placement or stimulation of the dorsal genital nerve (DGN).
- Active infection or injured/irritated skin in the genital area where the electrode is placed.
- Medically unstable due to acute illness or complications unrelated to OAB or BD.
- Has implanted pacemaker, implantable drug pump, or other active medical devices.
- Pregnant, nursing, planning pregnancy (confirmed by negative test), or gave birth within the last 12 months; women of childbearing potential must use effective contraception.
- Enrolled, or planning to enroll, in another conflicting clinical investigation or investigational drug/device trial within the last 12 weeks.
- Previously participated in a clinical investigation with UCon.
- Failed other neuromodulation treatments like sacral neuromodulation within 2 years.
- Has neurological diseases such as multiple sclerosis, stroke, Parkinson's, spinal cord injury, diabetic neuropathy, Guillain-Barré syndrome, or chronic inflammatory demyelinating polyneuropathy.
- History of cancer in the pelvic region, current cancer treatment, or radiation therapy in the pelvic region.
- Surgery in pelvic region within last 6 months unless symptoms unrelated to surgery.
- Addictive behavior involving alcohol, cannabis, opioids, or other intoxicating drugs.
- For OAB: Planned surgery or diagnostic procedure requiring catheterization or prolonged hospitalization during participation.
- Male participants with bladder outlet obstruction symptoms due to benign prostatic hyperplasia or prostate cancer.
- Polyuria or symptoms of polyuria.
- Current or recurring urinary tract infections (≥3 in last 12 months or ≥2 in last 6 months).
- Primary diagnosis of stress urinary incontinence or mixed incontinence with stress component likely to confound outcomes.
- Bladder Pain Syndrome or interstitial cystitis.
- Botulinum toxin treatment in pelvic region within 9 months or lasting benefit from it.
- Failed botulinum toxin treatment within last 2 years.
- Use of antimuscarinics or β3 agonists within 2 weeks.
- Started estrogen therapy within 3 months or planning to stop therapy during the study.
- For BD: Planned surgery or diagnostic procedure affecting bowel movements or prolonged hospitalization during participation.
- Currently treated with antibiotics.
- History of uncontrolled diarrhea or severe constipation in past 3 months (based on Bristol Stool Form Scale).
- History of inflammatory bowel disease (Crohn's or ulcerative colitis); irritable bowel syndrome allowed.
- Major anorectal or bowel surgery history or ongoing conditions requiring surgery unless symptoms unrelated to these conditions.
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Aarhus University Hospital
Aarhus, Denmark, 8200
Actively Recruiting
2
Herlev Hospital
Herlev, Denmark, 2730
Actively Recruiting
3
Odense University Hospital
Odense, Denmark, 5000
Actively Recruiting
Research Team
D
Dianna Mærsk Knudsen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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