Urinary IncontinenceNCT06754189
Safety and Performance of UCon Patch Electrode
A study testing Time Limited stimulation 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 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Incontinence, Urinary Incontinence, Urge, Nocturia
- What is being tested?
- Time Limited stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 3 sitesDenmark
- Study dates
- 20 Mar 2025to 20 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Participant is ≥ 18 years of age.
- Participant is diagnosed with OAB or BD.
- Participant is able to consent, communicate, provide feedback, and understand and follow instructions in Danish during the course of the investigation, including operation of the device at home.
Who cannot join
- Participant has genital anatomy that does not allow for proper electrode placement or stimulation of the DGN.
- Participant has an active infection in the genital area, including skin infections.
- Participant has injured or irritated skin in the genital area, where the electrode is placed.
- Participant is medically unstable (acute illness or complication of a chronic condition, apart from the OAB or BD, that might affect the participant's participation in the investigation).
- 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, planning a pregnancy (to be confirmed with a negative pregnancy test) or has given birth within the previous 12 months. Women of childbearing potential must maintain effective contraception* during the clinical investigation.
Show all 31Show fewer
- Participant is enrolled or planning to enroll in another conflicting clinical investigation or was enrolled in an investigational drug trial within the previous 12 weeks or medical device investigation within 12 weeks of enrolment.
- Participant has previously participated in a clinical investigation with UCon.
- Participant has failed (lack of effectiveness) other neuromodulation treatments, e.g. sacral neuromodulation (SNM) within the previous 2 years.
- Participant has a neurological disease, e.g., chronic inflammatory demyelinating polyneuropathy, multiple sclerosis, stroke, central nervous system (CNS) tumors, Parkinson´s, spinal cord injury, diabetic neuropathy, Guillain-Barré syndrome.
- Participant has a history of cancer in the pelvic region, is currently receiving cancer treatment, or has received radiation therapy in the pelvic region.
- Participant had surgery in the pelvic region within the previous 6 months. If it can be excluded that the participant's symptoms are related to the surgery, they can be included in the clinical investigation.
- Participant has addictive behavior defined as the abuse of alcohol, cannabis, opioids, or other intoxicating drugs.
- The following contraception is considered effective: Intrauterine device, hormonal contraceptives such as birth control pills, implants, contraceptive patch, vaginal ring, and contraceptive injection.
- Participant is planning or has a scheduled surgery/diagnostic procedure (within the duration of their participation) for any condition, that would require catheterization. Or have a prolonged hospitalization that would affect the ability to complete the stimulation.
- Participant (male) has symptoms of bladder outlet obstruction, e.g., caused by benign prostatic hyperplasia or prostate cancer.
- Participant has polyuria or symptoms of polyuria.
- Participant has a current or reoccurring urinary tract infection (≥3 or more within the previous 12 months or ≥2 within the previous 6 months).
- Participant has a primary diagnosis of stress urinary incontinence (SUI) or mixed incontinence with SUI likely to confound outcome measures.
- Participant has Bladder Pain Syndrome or interstitial cystitis.
- Participant has had botulinum toxin (BOTOX) treatment in the pelvic region within 9 months or has lasting benefit from BOTOX.
- Participant has failed (lack of effectiveness) BOTOX treatment within the previous 2 years.
- Participants who demonstrate detrusor overactivity on a urodynamic test can be included.
- Participant has used antimuscarinics or β3 agonists within 2 weeks.
- Participant has started oestrogen therapy within 3 months or are planning to stop therapy when enrolled in the clinical investigation.
- Participant is planning or has a scheduled surgery/diagnostic procedure (within the duration of their participation), for any condition, that would influence their bowel movements (e.g., injection of bulking agents, radiofrequency energy, or ligation of haemorrhoids). Or have a prolonged hospitalization that would affect the ability to complete the stimulation.
- Participant is currently being treated with antibiotics.
- Participant has a history of uncontrolled diarrhoea in the past 3 months (usual or most common stool type over the preceding 3 months of 7 on the Bristol Stool Form Scale).
- Participant has a history of severe constipation in the past 3 months (usual or most common stool type over the preceding 3 months of 1 on the Bristol Stool Form Scale).
- Participant has a history of inflammatory bowel disease (includes Crohn's disease and ulcerative colitis). Participants with irritable bowel syndrome can be included in the clinical investigation.
- Participant has undergone major anorectal or bowel surgery or has ongoing anorectal or bowel conditions where primary surgery is considered the best, e.g., congenital anorectal malformation, bowel resection surgery, unrepaired rectovaginal fistula, chronic 4th degree anal sphincter laceration, full thickness rectal/anal prolapse. If it can be excluded that the participant's symptoms are related to any of the above surgeries/conditions, they can be included in the clinical investigation.
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, 38681406 ext. +45, Niels.Klarskov@regionh.dk
- Recruiting
Odense University Hospital
Odense, 5000
Mark Bremholm Ellebæk, MD, 40880511 ext. +45, Mark.Ellebaek1@rsyd.dk
About this study
Official title: Safety and Performance of UCon Patch Electrode for the Treatment of Overactive Bladder (OAB) and Bowel Dysfunction (BD) - A Pivotal Clinical Investigation
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.
Read the detailed description
The overall purpose of this pivotal clinical investigation is to evaluate the UCon device with a Patch Electrode with respect to clinical safety and device performance in a cohort of 180 patients with OAB/BD over a period of 12 weeks.
The participants participate in a 12-week intervention period. For weeks 1-6, participants will be randomized (2:1 randomization) to either a treatment group using UCon-Patch with Time Limited stimulation or a sham group using UCon-Sham with sham stimulation. Participants in the treatment group will receive the actual stimulation with the intent of improving their symptoms, whereas those in the sham group will receive sham stimulation for short periods of time believed not to be capable of improving their symptoms.
For weeks 7-12 of the intervention periods, the treatment group has the opportunity to add Urge stimulation to the Time Limited stimulation, while the sham group shifts to using UCon-Patch Time Limited stimulation.
To assess the safety and performance of the UCon device on equal terms with similar devices in the market, the full intervention period with UCon will be conducted over 12 weeks, evaluating safety aspects of UCon on longer terms and confirming continued effects after 6 weeks in the treatment group. Additional analyses on data related to primary and secondary endpoints with safety and performance data from the 12-week follow-up will also be performed, but the primary analysis will focus on baseline and 6-week follow-up data.
- Conditions
- Urinary Incontinence, Urinary Incontinence, Urge, Nocturia, Urinary Frequency More Than Once at Night, Urinary, Incontinence, Nighttime Urinary
- Being tested
- Time Limited stimulation, Sham stimulation
- Keywords
- Urinary Incontinence, Fecal Incontinence, Urge incontinence, Neurostimulation, Dorsal Genital Nerve
- Medical subject headings
- Urinary Incontinence, Urinary Incontinence, Urge, Nocturia, Nocturnal Enuresis, Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time Limited stimulationDevice
Also called UCon-Patch
The participant self-administer 30 min. of electrical stimulation using Time Limited stimulation to the dorsal genital nerve (DGN) for 6 weeks using UCon with the UCon-Patch electrode.
Sham stimulationDevice
Also called UCon-Sham
The participant self-administer 30 min. of sham stimulation to the dorsal genital nerve (DGN) for 6 weeks using a sham device with the UCon-Patch electrode.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Electrical stimulation (Time Limited stimulation) to the dorsal genital nerve. Receives: Device: Time Limited stimulation |
| Sham group | Sham comparator | Sham stimulation to the dorsal genital nerve. Receives: Device: Sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of serious adverse device effects (SADEs).
Number of SADEs.
Measured: At 12 weeks.
Ratio of treatment change [performance] of OAB symptoms.
Percentage of participants using UCon-Patch, compared to participants using UCon-Sham, demonstrating at least a 50% reduction in Urinary Urgency (UU) voids (with or without Urgency Urinary Incontinence, UUI).
Measured: Change from baseline at 6 weeks.
Ratio of treatment change [performance] of BD symptoms.
Percentage of participants using UCon-Patch, compared to participants using UCon-Sham, demonstrating at least a 50% reduction in Faecal Urgency (FU) episodes OR at least a 50% reduction in Faecal Incontinence (FI) episodes.
Measured: Change from baseline at 6 weeks.
Secondary outcomes (6)
Incidence and severity of adverse events (AEs).
Number of AEs.
Measured: At 12 weeks.
Ratio of treatment change [performance] of Urgency Urinary Incontinence.
Percentage of participants using UCon-Patch, compared to participants using UCon-Sham, demonstrating at least a 50% reduction in Urgency Urinary Incontinence (UUI).
Measured: Change from baseline at 6 weeks.
Self-reported quality of life measures as assessed by the International Consultation on Incontinence Questionnaire Overactive Bladder Quality of Life Module (ICIQ-OABqol) questionnaire.
The ICIQ-OABqol score of participants using UCon-Patch, compared to participants using UCon-Sham (scores can range from 0 to 100, with lower values indicating higher QoL).
Measured: Change from baseline at 6 weeks.
Faecal Urgency (FU) episodes.
Mean reduction in number of Faecal Urgency (FU) episodes of participants using UCon-Patch, compared to participants using UCon-Sham.
Measured: Change from baseline at 6 weeks.
Faecal Incontinence (FI) episodes.
Mean reduction in number of Faecal Incontinence (FI) episodes of participants using UCon-Patch, compared to participants using UCon-Sham.
Measured: Change from baseline at 6 weeks.
Self-reported quality of life measures as assessed by the Rockwood Fecal Incontinence Quality of Life Scale (FIQL) questionnaire.
The FIQL score of participants using UCon-Patch, compared to participants using UCon-Sham (the scale consists of 4 scales, with each scale ranging from 1-5, with 1 indicating a lower functional QoL).
Measured: Change from baseline at 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start20 Mar 2025
- Primary completion20 Mar 2028 (estimated)
- Study completion20 Mar 2028 (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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to a treatment group and a sham group.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 180 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
- NCT06754189
- Sponsor's protocol ID
- DK_PIVO_01
- Status last verified
- Mar 2025
- First submitted
- 23 Dec 2024
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Performance of UCon Patch Electrode for the Treatment of Overactive Bladder (OAB) and Bowel Dysfunction (BD) - A Pivotal Clinical Investigation
- ClinicalTrials.gov ID
- NCT06754189
- Acronym / sponsor ID
- DK_PIVO_01
- Conditions
- Urinary Incontinence, Urinary Incontinence, Urge, Nocturia, Urinary Frequency More Than Once at Night, Urinary, Incontinence, Nighttime Urinary
- Keywords
- Urinary Incontinence, Fecal Incontinence, Urge incontinence, Neurostimulation, Dorsal Genital Nerve
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- InnoCon MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Aarhus University Hospital, Odense University Hospital, Herlev Hospital
- Study start
- 20 Mar 2025 (actual)
- Primary completion
- 20 Mar 2028 (estimated)
- Study completion
- 20 Mar 2028 (estimated)
- First posted
- 31 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The overall purpose of this pivotal clinical investigation is to evaluate the UCon device with a Patch Electrode with respect to clinical safety and device performance in a cohort of 180 patients with OAB/BD over a period of 12 weeks.
The participants participate in a 12-week intervention period. For weeks 1-6, participants will be randomized (2:1 randomization) to either a treatment group using UCon-Patch with Time Limited stimulation or a sham group using UCon-Sham with sham stimulation. Participants in the treatment group will receive the actual stimulation with the intent of improving their symptoms, whereas those in the sham group will receive sham stimulation for short periods of time believed not to be capable of improving their symptoms.
For weeks 7-12 of the intervention periods, the treatment group has the opportunity to add Urge stimulation to the Time Limited stimulation, while the sham group shifts to using UCon-Patch Time Limited stimulation.
To assess the safety and performance of the UCon device on equal terms with similar devices in the market, the full intervention period with UCon will be conducted over 12 weeks, evaluating safety aspects of UCon on longer terms and confirming continued effects after 6 weeks in the treatment group. Additional analyses on data related to primary and secondary endpoints with safety and performance data from the 12-week follow-up will also be performed, but the primary analysis will focus on baseline and 6-week follow-up data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are assigned to a treatment group and a sham group.
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Device: Time Limited stimulationElectrical stimulation (Time Limited stimulation) to the dorsal genital nerve. |
| Sham group | Sham comparator | Device: Sham stimulationSham stimulation to the dorsal genital nerve. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participant is ≥ 18 years of age.
- Participant is diagnosed with OAB or BD.
- Participant is able to consent, communicate, provide feedback, and understand and follow instructions in Danish during the course of the investigation, including operation of the device at home.
Key exclusion criteria (31 listed)
- Participant has genital anatomy that does not allow for proper electrode placement or stimulation of the DGN.
- Participant has an active infection in the genital area, including skin infections.
- Participant has injured or irritated skin in the genital area, where the electrode is placed.
- Participant is medically unstable (acute illness or complication of a chronic condition, apart from the OAB or BD, that might affect the participant's participation in the investigation).
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Time Limited stimulationAlso: UCon-PatchThe participant self-administer 30 min. of electrical stimulation using Time Limited stimulation to the dorsal genital nerve (DGN) for 6 weeks using UCon with the UCon-Patch electrode. | Device | Treatment group |
| Sham stimulationAlso: UCon-ShamThe participant self-administer 30 min. of sham stimulation to the dorsal genital nerve (DGN) for 6 weeks using a sham device with the UCon-Patch electrode. | Device | Sham group |
Primary outcome
Incidence of serious adverse device effects (SADEs).
Time frame: At 12 weeks.
Number of SADEs.
Ratio of treatment change [performance] of OAB symptoms.
Time frame: Change from baseline at 6 weeks.
Percentage of participants using UCon-Patch, compared to participants using UCon-Sham, demonstrating at least a 50% reduction in Urinary Urgency (UU) voids (with or without Urgency Urinary Incontinence, UUI).
Ratio of treatment change [performance] of BD symptoms.
Time frame: Change from baseline at 6 weeks.
Percentage of participants using UCon-Patch, compared to participants using UCon-Sham, demonstrating at least a 50% reduction in Faecal Urgency (FU) episodes OR at least a 50% reduction in Faecal Incontinence (FI) episodes.
6 secondary outcomes
Incidence and severity of adverse events (AEs).
Time frame: At 12 weeks.
Ratio of treatment change [performance] of Urgency Urinary Incontinence.
Time frame: Change from baseline at 6 weeks.
Self-reported quality of life measures as assessed by the International Consultation on Incontinence Questionnaire Overactive Bladder Quality of Life Module (ICIQ-OABqol) questionnaire.
Time frame: Change from baseline at 6 weeks.
Faecal Urgency (FU) episodes.
Time frame: Change from baseline at 6 weeks.
Faecal Incontinence (FI) episodes.
Time frame: Change from baseline at 6 weeks.
Self-reported quality of life measures as assessed by the Rockwood Fecal Incontinence Quality of Life Scale (FIQL) questionnaire.
Time frame: Change from baseline at 6 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peter Christensen, MD principal investigator
Palle Juul Jensens Boulevard 99 DK-8200 Aarhus N
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time Limited stimulation in people with Urinary Incontinence and Urinary Incontinence, Urge, run by InnoCon Medical at 3 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dianna Mærsk Knudsen (40517712 ext. +45, dmk@innoconmedical.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of serious adverse device effects (SADEs). (time frame: At 12 weeks.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.