Urinary IncontinenceNCT05368246
Safety and Performance of UCon for the Treatment of the Symptoms of Overactive Bladder (OAB) / Bowel Dysfunction (BD)
A study testing UCon in people with Urinary Incontinence and Fecal Incontinence, run by InnoCon Medical at 3 sites in Denmark.
Trial summary
This clinical investigation is a single-arm, prospective, multicentre, early feasibility study, which is used to evaluate the device design of UCon with respect to initial clinical safety and device performance in a small number of subjects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Incontinence, Fecal Incontinence, Urge Incontinence
- What is being tested?
- UCon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 3 sitesDenmark
- Study dates
- 15 Feb 2022to 15 Jan 2024
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is ≥ 18 years of age.
- Subject is diagnosed with OAB or BD.
- Subject is able to communicate, provide feedback, understand and follow instructions during the course of the study.
- Subject has signed an informed consent.
Who cannot join
- Subject is medically unstable.
- Subject has an active infection in the genital area.
- Subject has an implanted pacemaker, implantable drug pump or other active medical device (any medical device that uses electrical energy or other source of power to make it function).
- Subject is pregnant, nursing or planning a pregnancy (to be confirmed with a negative pregnancy test within 14 days prior to enrolment). Women of childbearing potential must maintain effective contraception* during the study period judged by the investigator.
- Subject is enrolled or planning to enrol in another investigational study or was enrolled in an investigational drug or medical device trial within four weeks to enrolment.
- Subject has neuropathy to a degree that is presumed to diminish the effect of the electrical stimulation.
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- Subject has a history of cancer in the pelvic region, are currently receiving cancer treatment, or has radiation-induced damage to the pelvic region.
- Subject has addictive behaviour defined as abuse of cannabis, opioids, or other intoxicating drugs.
- Subject does not speak and understand Danish.
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Aarhus University Hospital
Aarhus, Aarhus N, 8200
Herlev Hospital
Herlev, Region Sjælland, 2730
Odense University Hospital
Odense, 5000
About this study
Official title: Safety and Performance of UCon for the Treatment of the Symptoms of Overactive Bladder (OAB) / Bowel Dysfunction (BD) - An Early Feasibility Study
This clinical investigation is a single-arm, prospective, multicentre, early feasibility study, which is used to evaluate the device design of UCon with respect to initial clinical safety and device performance in a small number of subjects. UCon is a medical device for treatment of the symptoms of overactive bladder (OAB) and bowel disorders (BD). It electrically stimulates the dorsal genital nerve (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 the detailed description
The study is conducted at multiple hospitals in Denmark (Aarhus University Hospital, Odense University Hospital and Herlev Hospital). It is estimated that 20 subjects with OAB and 20 subjects with BD will need to be enrolled at the investigational sites to account for screening attrition and dropouts. Screening and baseline measurements includes a 7-days bladder diary (OAB) / 14-days bowel diary (BD) and quality-of-life measures. Following the screening and baseline measurements, the subjects will be introduced and trained on how to set up and use UCon. For 1 month the subjects will use UCon at home and complete a daily bladder/bowel diary and a stimulation diary. After completion of the interventional period, subjects will fill out the quality-of-life measures once again.
- Conditions
- Urinary Incontinence, Fecal Incontinence, Urge Incontinence, Nocturia, Urinary Frequency More Than Once at Night, Bowel Disorders Functional
- Being tested
- UCon
- Keywords
- Urinary Incontinence, Fecal Incontinence, Urge incontinence, Neurostimulation, Dorsal Genital Nerve, Nocturia
- Medical subject headings
- Urinary Incontinence, Fecal Incontinence, Urinary Incontinence, Urge, Nocturia, Nocturnal Enuresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UConDevice
The subjects self-administer electrical stimulation to the dorsal genital nerve (DGN) for 4 weeks using UCon
| Study group | Role | What they receive |
|---|---|---|
| Interventional arm | Experimental | Electrical stimulation to the dorsal genital nerve. Receives: Device: UCon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of adverse events related to the risks and anticipated adverse device effects associated with the use of UCon.
Characterization of adverse events related to the risks and anticipated adverse device effects associated with the use of UCon during the study period.
Measured: After 4 and 12 weeks of stimulation (end of study).
Ratio of subjects with at least 50% improvement of their OAB/BD symptoms from baseline associated with the use of UCon.
Urinary urgency is measured by number of urgency episodes/day. Urinary frequency is measured by number of voidings/day. Urgency urinary incontinence is measured by number of leaks preceded by urgency/day.
Nocturia is measured by number of voidings/night. Faecal urgency is measured by number of urgency episodes/day. Frequent bowel movements are measured by number of voidings/day. Faecal incontinence (urge/passive) is measured by number of leaks/day.
Measured: Change from baseline OAB/BD symptoms at 4 and 12 weeks.
Secondary outcomes (2)
Frequency and severity of all adverse events related to the risks and anticipated adverse device effects associated with the use of UCon.
Number of subjects experiencing adverse events related to the risks and anticipated adverse device effects associated with the use of UCon during the study period.
Number and severity of adverse events related to the risks and anticipated adverse device effects associated with the use of UCon during the study period.
Measured: After 4 and 12 weeks of stimulation (end of study).
Ratio of subjects with improvement in their OAB/BD specific quality-of-life measures from baseline.
For OAB the following is used to assess QoL: "International Consultation on Incontinence Questionnaire Overactive Bladder Module". It contains 4 questions and a higher total score means a worse outcome.
For BD a combination of the following is used to assess QoL: "St. Marks incontinence score" and "Rockwood Fecal Incontinence Quality of Life Scale". St. Marks incontinence score contains 7 questions, and a higher total score means a worse outcome. The Rockwood Fecal Incontinence Quality of Life Scale contains 29 questions and a higher total score means a worse outcome.
Measured: Change from baseline QoL at 4 and 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start15 Feb 2022
- Primary completion15 Jan 2024
- Study completion15 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- InnoCon Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Aarhus University Hospital, Herlev Hospital, Odense University Hospital
- Responsible party
- Sponsor
- Investigators
- Peter Christensen, Principal investigator, Palle Juul Jensens Boulevard 99 DK-8200 Aarhus N
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05368246
- Sponsor's protocol ID
- DK_FEAS_01
- Status last verified
- Feb 2024
- First submitted
- 25 Apr 2022
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Grau LS, Christensen P, Qvist N, Klarskov N, Rijkhoff N, Duelund-Jakobsen J. Dorsal Genital Nerve Stimulation in Patients With Fecal Incontinence and Fecal Urgency: A Feasibility Study With the Novel UCon Neurostimulator. Neurogastroenterol Motil. 2026 May;38(5):e70225. doi: 10.1111/nmo.70225. Epub 2025 Dec 20.
PubMed 41420462