Urinary IncontinenceNCT06091566
Safety and Performance of UCon Bar Electrode for the Treatment of Overactive Bladder (OAB) and Bowel Dysfunction (BD)
A study testing UCon-Bar in people with Urinary Incontinence and Urinary Incontinence, Urge, run by InnoCon Medical at 3 sites in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Incontinence, Urinary Incontinence, Urge, Fecal Incontinence
- What is being tested?
- UCon-Bar
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesDenmark
- Study dates
- 12 Jan 2024to 1 Jan 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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:
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- Faecal urgency (≥3 urgencies pr. week) together with registration of urgency in St. Mark´s and a St. Mark´s score ≥9.
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark3 sites, 3 recruiting
- Recruiting
Aarhus University Hospital
Aarhus, 8200
Peter Christensen, MD, 20375471 ext. +45, petchris@rm.dk
Jakob Jakobsen, MD
- Recruiting
Herlev Hospital
Herlev, 2730
Niels Klarskov, MD, 38 68 14 06 ext. +45, Niels.Klarskov@regionh.dk
- Recruiting
Odense University Hospital
Odense, 5000
Mark Bremholm Ellebæk, MD, 40 88 05 11 ext. +45, Mark.Ellebaek1@rsyd.dk
About this study
Official title: Safety and Performance of UCon Bar Electrode for the Treatment of Overactive Bladder (OAB) and Bowel Dysfunction (BD) - An Early Feasibility Study
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.
Read the detailed description
The overall purpose of the current clinical investigation is to evaluate the medical device with a UCon-Bar Electrode with respect to its initial safety and device performance in a cohort of 40 female patients with OAB/BD over a period of 12 weeks.
The investigation consists of two periods: a screening period and an intervention period.
During the screening period, the participants will be using UCon with a Patch Electrode and complete a 4 week stimulation period at home. The screening period will determine if participants fulfil the criteria to participate in the intervention period.
During the intervention period, the UCon Bar Electrode will be inserted in the clitoral hood. After a recovery period (4-8 weeks), the participants will be using UCon with the Bar Electrode and complete wither a 4 week or a 12 week stimulation period at home.
- Conditions
- Urinary Incontinence, Urinary Incontinence, Urge, Fecal Incontinence, Fecal Incontinence With Fecal Urgency, Nocturia, Urinary Frequency More Than Once at Night
- Being tested
- UCon-Bar
- Keywords
- Urinary Incontinence, Fecal Incontinence, Urge incontinence, Neurostimulation, Dorsal Genital Nerve
- Medical subject headings
- Urinary Incontinence, Urinary Incontinence, Urge, Fecal Incontinence, Nocturia, Nocturnal Enuresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UCon-BarDevice
Also called Electrical stimulation to the dorsal genital nerve (DGN stimulation)
The participant self-administer electrical stimulation to the dorsal genital nerve (DGN) for either 4 weeks or 12 weeks using UCon with the Bar electrode
| Study group | Role | What they receive |
|---|---|---|
| Electrical stimulation | Experimental | Electrical stimulation to the dorsal genital nerve. Receives: Device: UCon-Bar |
What is being measured
The primary outcome is the main question the study is designed to answer.
PRIMARY SAFETY: ratio of participants with successful insertion of the UCon Bar Electrode.
- Number and severity of adverse events during insertion of the UCon Bar Electrode: Excessive pain and excessive bleeding. 2) Number and severity of adverse events after insertion: Infection, pain, and bleeding. 3) Number of participants with successful insertion with no premature removal of the Bar Electrode.
Measured: After 4 weeks and 12 weeks
PRIMARY PERFORMANCE: ratio of treatment change [performance] of OAB/BD symptoms
Ratio of participants with at least 50% reduction of their OAB/BD symptoms from baseline as assessed by subjective reporting in an electronic bladder or bowel diary.
Measured: Change from baseline at 4 weeks and/or 12 weeks
Secondary outcomes (6)
SECONDARY SAFETY: Characterization, including frequency and severity of adverse events related to the risks and anticipated adverse device effects associated with the use of UCon-Bar Electrode.
- Characterization of adverse events and adverse device effects associated with the use of UCon-Bar during the investigational period.2) Number of participants experiencing adverse events and adverse device effects associated with the use of UCon-Bar during the investigational period.3) Number and severity of adverse events and adverse device effects associated with the use of UCon-Bar during the investigational period.
Measured: After 4 weeks and 12 weeks
SECONDARY PERFORMANCE: ratio of treatment change [performance] of OAB/BD symptoms
Ratio of participants with at least 33% reduction of their OAB/BD symptoms from baseline as assessed by subjective reporting in an electronic bladder or bowel diary.
Measured: Change from baseline at 4 weeks and/or 12 weeks
SECONDARY PERFORMANCE: assess whether participants using UCon Bar Electrode experience a change in their quality of life
Ratio of subjects with a change in their self-reported quality of life measures as assessed by specific QoL questionnaires related to OAB (ICIQ-OAB, an overall score with greater values indicates increased symptom severity) or BD (St. Marks incontinence score and Rockwood Fecal Incontinence Quality of Life Scale, an overall score with greater values indicates a worse symptom outcome.)
Measured: Change from baseline at 4 weeks and/or 12 weeks
SECONDARY PERFORMANCE: assess whether participants using UCon Bar Electrode experience an impression of treatment improvement
Ratio of participants with a self-reported improvement in their impression of treatment as assessed by the 7-point Patient Global Impression of Improvement (PGI-I) scale. An improvement is defined as choosing one of the following: very much, better, much better, or a little better.
Measured: After 4 week screening period, 4 weeks, and 12 weeks
SECONDARY PERFORMANCE: ratio of participant that accept UCon and DGN stimulation [Device and treatment acceptability of UCon]
Ratio of participants that accept UCon and DGN stimulation as assessed by a satisfaction survey recorded after each stimulation periods (with UCon Patch Electrode and UCon Bar Electrode) .
Measured: After 4 week screening period, 4 weeks, and 12 weeks
Secondary PERFORMANCE: ratio of treatment change [performance] of OAB/BD symptoms during the screening period can be reproduced in the intervention period.
Ratio of participants with at least 50% reduction in symptoms using the UCon-Patch Electrode, that can be reproduced in 80% of the participants using the UCon Bar Electrode.
Measured: Change from screening period at 4 weeks and/or 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start12 Jan 2024
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-group assignment
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InnoCon Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Aarhus University Hospital, Odense University Hospital, Herlev Hospital
- Responsible party
- Sponsor
- Investigators
- Peter Christensen, MD, Principal investigator, Palle Juul Jensens Boulevard 99 DK-8200 Aarhus N
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06091566
- Sponsor's protocol ID
- DK_FEAS_02
- Status last verified
- Feb 2026
- First submitted
- 16 Oct 2023
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No