Actively Recruiting
Safety and Performance of UCon Bar Electrode for the Treatment of Overactive Bladder (OAB) and Bowel Dysfunction (BD) - An Early Feasibility Study
Led by InnoCon Medical · Updated on 2026-02-18
20
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
Sponsors
I
InnoCon Medical
Lead Sponsor
A
Aarhus University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the UCon medical device with a Bar Electrode for treating symptoms of overactive bladder (OAB) and bowel dysfunction (BD) in female patients. This early feasibility clinical investigation aims to assess both the initial safety and performance of the device in a group of 40 women over 12 weeks. The UCon device electrically stimulates the dorsal genital nerve (DGN) through the skin to help manage bladder and bowel muscle activity and relieve symptoms. The study includes two main periods: screening and intervention. During the screening phase, participants use the UCon device with a Patch Electrode at home for 4 weeks to determine eligibility for the next phase. In the intervention period, the Bar Electrode is inserted into the clitoral hood, followed by a recovery time of 4 to 8 weeks. After recovery, participants self-administer electrical stimulation using the Bar Electrode at home for either 4 or 12 weeks. Participants will be closely monitored throughout the study with assessments of device safety, proper electrode insertion, and symptom changes at 4 and 12 weeks. Researchers will evaluate treatment effects on OAB and BD symptoms, quality of life, and user acceptance of the device. Safety monitoring includes tracking adverse events, and participants will provide feedback during the study. The total study duration for each participant includes screening, recovery, and intervention phases.
CONDITIONS
Brief 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 of age or older
- Participant is diagnosed with overactive bladder (OAB) or bowel dysfunction (BD)
- For OAB: urinary urgency with one or more of the following: urgency incontinence at least once per week, urinary frequency of 8 or more voids per day without polyuria, or nocturia of 2 or more voids per night without nocturnal polyuria
- For BD: fecal urgency at least 3 times per week with St. Mark's score 9 or higher, or fecal incontinence (urge or passive) at least once per week
- Participant can communicate, provide feedback, understand, and follow instructions including device use at home
You will not qualify if you...
- Participant is medically unstable due to acute illness or chronic condition complications (other than OAB or BD)
- Participant has an active infection in the genital area
- Participant has an implanted pacemaker, implantable drug pump, or other active medical devices
- Participant is pregnant, nursing, or planning pregnancy (confirmed by negative pregnancy test); women of childbearing potential must use effective contraception
- Participant is enrolled or planning to enroll in another conflicting clinical trial or has been in one within the past 4 weeks
- Participant has neuropathy expected to reduce electrical stimulation effects
- Participant has history of cancer in the pelvic region, is currently receiving cancer treatment, or has had pelvic radiation therapy
- Participant has addictive behavior involving alcohol, cannabis, opioids, or other intoxicating drugs
- Participant does not speak or understand Danish
- Effective contraception methods include intrauterine devices and hormonal contraceptives such as birth control pills, implants, patches, vaginal rings, and injections
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial. During this period, participants will use the UCon device with a Patch Electrode at home for 4 weeks to determine if they qualify for the intervention.
1 screening and enrollment visit
Duration - Approximately 8 to 20 weeks including recovery and stimulation periods
Participants will have the UCon Bar Electrode inserted in the clitoral hood. After a recovery period of 4 to 8 weeks, they will self-administer electrical stimulation to the dorsal genital nerve at home using the UCon Bar Electrode for either 4 weeks or 12 weeks.
1 visit for electrode insertion and recovery monitoring; home use during stimulation period
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
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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