Actively Recruiting
Safety and Performance of UCon Bar Electrode for the Treatment of Overactive Bladder (OAB) and Bowel Dysfunction (BD)
Led by InnoCon Medical · Updated on 2026-02-18
20
Participants Needed
3
Research Sites
155 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 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.
CONDITIONS
Official Title
Safety and Performance of UCon Bar Electrode for the Treatment of Overactive Bladder (OAB) and Bowel Dysfunction (BD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant is female
- Participant is 18 years or older
- Participant is diagnosed with overactive bladder (OAB) or bowel dysfunction (BD)
- For OAB: urinary urgency with at least one of the following - urinary urgency incontinence (1 or more times per week), urinary frequency (8 or more voids per day without polyuria), or nocturia (2 or more voids per night without nocturnal polyuria)
- For BD: at least one of the following - fecal urgency (3 or more episodes per week) with urgency registration and a St. Mark's score of 9 or higher, or fecal incontinence (urge or passive) 1 or more times per week
- Ability to communicate, provide feedback, understand, and follow instructions during the study, including device use at home
You will not qualify if you...
- Participant is medically unstable due to acute illness or a complication of a chronic condition other than OAB or BD
- Active infection in the genital area
- Presence of implanted pacemaker, implantable drug pump, or other active medical devices using electrical energy or power
- Pregnancy, nursing, or planning pregnancy (must have negative pregnancy test and use effective contraception during the study)
- Currently enrolled or planning to enroll in another conflicting clinical investigation or investigational drug/device trial within four weeks before enrollment
- Neuropathy that may reduce the effect of electrical stimulation
- History of cancer in the pelvic area, ongoing cancer treatment, or prior radiation therapy in the pelvic region
- Addictive behaviors including abuse of alcohol, cannabis, opioids, or other intoxicating drugs
- Does not speak or understand Danish
- Effective contraception includes intrauterine device, hormonal contraceptives, contraceptive patch, vaginal ring, and contraceptive injection
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
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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