Urinary IncontinenceNCT05874375
UCon Treatment of Overactive Bladder (OAB) in Males
A study testing Urge stimulation and Time limited stimulation in people with Urinary Incontinence and Urge Incontinence, run by InnoCon Medical at 1 site in Netherlands.
Trial summary
UCon is a medical device for treatment of the symptoms of OAB and fecal incontinence (FI). It electrically stimulates the DGN through the skin to obtain modulated behaviour of the bladder musculature e.g., suppress undesired bladder activity to relieve the symptoms of the patient. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Urinary Incontinence, Urge Incontinence, Nocturia
- What is being tested?
- Urge stimulation and Time limited stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 12 Oct 2023to 12 Jun 2027
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is ≥ 18 years of age.
- Subject is male.
- Subject is diagnosed with OAB
- Subject is able to communicate, provide feedback, understand and follow instructions during the course of the investigation.
Who cannot join
- Subject is medically unstable (acute illness or complications of a chronic condition that might affect the subject's participation in the investigation).
- Subject has a Post Void Residual (PVR) of more than 100 ml or a Bladder Voiding Efficiency (BVE) of less than 75% (measured by uroflowmetry as the ratio of voided volume (VV) and total bladder capacity (VV+PVR)).
- Subject has an active infection in the genital area incl. skin infections and urinary tract infection.
- Subject has had botulinum toxin (BOTOX) treatment in the pelvic region within 6 months.
- Subject has used antimuscarinics or β3 agonists within 14 days weeks*.
- 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).
Show all 12Show fewer
- Subject is enrolled or planning to enrol in another clinical investigation or was enrolled in an investigational drug study or medical device investigation within four weeks to enrolment.
- Subject has neuropathy to a degree that is presumed to diminish the effect of the electrical stimulation.
- 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 alcohol, cannabis, opioids, or other intoxicating drugs.
- Subject does not speak and understand Dutch.
- If a subject is currently being treated with antimuscarinics or β3 agonists, he is allowed to be included in the investigation, however, a washout period of 14 days is required before baseline can be established.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht University Medical Center+
Maastricht
John Heesakkers, MD, 433877258 ext. +31, john.heesakkers@mumc.nl
About this study
Official title: Safety and Performance of UCon for Management of Non-Neurogenic OAB in Males - An Early Feasibility Study
UCon is a medical device for treatment of the symptoms of OAB and fecal incontinence (FI). It electrically stimulates the DGN through the skin to obtain modulated behaviour of the bladder musculature e.g., suppress undesired bladder activity to relieve the symptoms of the patient. This clinical investigation is a randomized, cross-over, single-site, prospective, early feasibility study, which is used to evaluate Ucon with respect to its initial clinical safety and device performance in a small number of males with OAB.
Read the detailed description
The purpose of the current investigation is to obtain information about the type of stimulation that Ucon provide (time limited vs. urge stimulation), would be the most effective and feasible for the treatment of non-neurogenic OAB symptoms in males.
- Conditions
- Urinary Incontinence, Urge Incontinence, Nocturia, Urinary Frequency More Than Once at Night, Urinary Incontinence, Urge, Incontinence, Nighttime Urinary
- Being tested
- Urge stimulation, Time limited stimulation
- Keywords
- Urinary Incontinence, Urge incontinence, Neurostimulation, Dorsal Genital Nerve, Nocturia
- Medical subject headings
- Urinary 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.
Urge stimulationDevice
Also called DGN stimulation, Neurostimulation
Participants will receive stimulation for 60 seconds, when they feel an urgency.
Time limited stimulationDevice
Also called DGN stimulation, Neurostimulation
Participant will receive the stimulation as provided in time limited sessions (Range: 15 min - continuous), whenever it suits the participant during the day.
| Study group | Role | What they receive |
|---|---|---|
| Group A (Urge and Time limited) | Other | The participant self-administer electrical stimulation to the dorsal genital nerve (DGN) using UCon with a stimulation mode that is activated for 60 seconds by the participant when he experience urgency (urge stimulation).The urge stimulation can be activated repeatedly during the day as the participant wears the device from morning to evening at home for 14 days. Following a stimulation wash-out period (14 days), the participants then stimulates with UCon for another 14 days using the time limited stimulation mode. Receives: Device: Urge stimulation; Device: Time limited stimulation |
| Group B (Time limited and Urge) | Other | The participant self-administer electrical stimulation to the dorsal genital nerve (DGN) using UCon with a stimulation mode that is activated for 30 minutes once a day, at a time that is convenient for the participant. The participant uses the device at home for 14 days. Following a stimulation wash-out period (14 days), the participant then stimulates with UCon for another 14 days using the urge stimulation mode. Receives: Device: Urge stimulation; Device: Time limited stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
PRIMARY SAFETY: To evaluate adverse events [initial safety] of UCon for treatment of OAB symptoms in a home setting.
Characterization of adverse events and anticipated adverse device effects associated with the use of UCon during the investigational period.
Measured: After 44 days (end of study)
PRIMARY PERFORMANCE: To evaluate the ratio of treatment change [performance] of OAB symptoms using UCon in a home setting
Ratio of subjects with at least 50% change in their OAB symptoms from baseline. Participants shall complete a 3-day bladder diary to report their symptoms.
The symptoms related to OAB:
- 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.
Measured: Change from baseline at 14 days, 30 days and 44 days (study end)
Secondary outcomes (5)
SECONDARY SAFETY: To identify the number of subjects experiencing adverse events associated with the use of UCon during the investigational period.
Number of subjects experiencing adverse events and anticipated adverse device effects. Subjects will report on any experience associated with the use of UCon.
Measured: After 44 days (end of study)
SECONDARY SAFETY: To evaluate the severity of adverse events associated with the use of UCon during the investigational period.
Severity of adverse events and anticipated adverse device effects.The severity will be evaluated from the subjects' report on any experience associated with the use of UCon.
Measured: After 44 days (study end)
SECONDARY PERFORMANCE: To evaluate whether subjects using UCon experience a change in their quality of life.
Ratio of subjects with a change in their OAB quality of life measures as assessed by specific QoL questionnaires related to OAB condition (ICIQ-OAB, AOBq). An overall score with greater values indicates a worse symptom outcome.
Measured: Change from baseline at 14 days and 44 days (end of study)
SECONDARY PERFORMANCE: To evaluate whether subjects using UCon experience a change in their treatment outcome (i.e. symptoms) after therapy.
Ratio of subjects with a change in their treatment outcome (i.e. symptoms) assessed by the 7-point Patient Global Impression of Improvement (PGI-I) scale. Higher scores indicates a worse treatment outcome.
Measured: Change from baseline at 14 days and 44 days (end of study)
SECONDARY PERFORMANCE: To evaluate the device and treatment acceptability of UCon.
Ratio of subjects that accept UCon and DGN stimulation as assessed by a satisfaction survey recorded after each stimulation period.
Measured: After 44 days (study end)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start12 Oct 2023
- Primary completion12 Jun 2027 (estimated)
- Study completion12 Jun 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InnoCon Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Heesakkers, MD, Principal investigator, Maastricht UMC+, P. Debyelaan 25, 6229 HX Maastricht, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05874375
- Sponsor's protocol ID
- NL_FEAS_01
- Status last verified
- Nov 2026
- First submitted
- 1 May 2023
- Last updated
- 6 Nov 2026
- 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 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Performance of UCon for Management of Non-Neurogenic OAB in Males - An Early Feasibility Study
- ClinicalTrials.gov ID
- NCT05874375
- Acronym / sponsor ID
- NL_FEAS_01
- Conditions
- Urinary Incontinence, Urge Incontinence, Nocturia, Urinary Frequency More Than Once at Night, Urinary Incontinence, Urge, Incontinence, Nighttime Urinary
- Keywords
- Urinary Incontinence, Urge incontinence, Neurostimulation, Dorsal Genital Nerve, Nocturia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- InnoCon MedicalIndustry (pharma, biotech, devices)
- Study start
- 12 Oct 2023 (actual)
- Primary completion
- 12 Jun 2027 (estimated)
- Study completion
- 12 Jun 2027 (estimated)
- First posted
- 24 May 2023 (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 treatment of the symptoms of OAB and fecal incontinence (FI). It electrically stimulates the DGN through the skin to obtain modulated behaviour of the bladder musculature e.g., suppress undesired bladder activity to relieve the symptoms of the patient. This clinical investigation is a randomized, cross-over, single-site, prospective, early feasibility study, which is used to evaluate Ucon with respect to its initial clinical safety and device performance in a small number of males with OAB.
Detailed description
The purpose of the current investigation is to obtain information about the type of stimulation that Ucon provide (time limited vs. urge stimulation), would be the most effective and feasible for the treatment of non-neurogenic OAB symptoms in males.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Urge and Time limited) | Other | Device: Urge stimulation, Device: Time limited stimulationThe participant self-administer electrical stimulation to the dorsal genital nerve (DGN) using UCon with a stimulation mode that is activated for 60 seconds by the participant when he experience urgency (urge stimulation).The urge stimulation can be activated repeatedly during the day as the participant wears the device from morning to evening at home for 14 days. Following a stimulation wash-out period (14 days), the participants then stimulates with UCon for another 14 days using the time limited stimulation mode. |
| Group B (Time limited and Urge) | Other | Device: Urge stimulation, Device: Time limited stimulationThe participant self-administer electrical stimulation to the dorsal genital nerve (DGN) using UCon with a stimulation mode that is activated for 30 minutes once a day, at a time that is convenient for the participant. The participant uses the device at home for 14 days. Following a stimulation wash-out period (14 days), the participant then stimulates with UCon for another 14 days using the urge stimulation mode. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject is ≥ 18 years of age.
- Subject is male.
- Subject is diagnosed with OAB
- Subject is able to communicate, provide feedback, understand and follow instructions during the course of the investigation.
Key exclusion criteria (12 listed)
- Subject is medically unstable (acute illness or complications of a chronic condition that might affect the subject's participation in the investigation).
- Subject has a Post Void Residual (PVR) of more than 100 ml or a Bladder Voiding Efficiency (BVE) of less than 75% (measured by uroflowmetry as the ratio of voided volume (VV) and total bladder capacity (VV+PVR)).
- Subject has an active infection in the genital area incl. skin infections and urinary tract infection.
- Subject has had botulinum toxin (BOTOX) treatment in the pelvic region within 6 months.
- Subject has used antimuscarinics or β3 agonists within 14 days weeks*.
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 |
|---|---|---|
| Urge stimulationAlso: DGN stimulation, NeurostimulationParticipants will receive stimulation for 60 seconds, when they feel an urgency. | Device | Group A (Urge and Time limited), Group B (Time limited and Urge) |
| Time limited stimulationAlso: DGN stimulation, NeurostimulationParticipant will receive the stimulation as provided in time limited sessions (Range: 15 min - continuous), whenever it suits the participant during the day. | Device | Group A (Urge and Time limited), Group B (Time limited and Urge) |
Primary outcome
PRIMARY SAFETY: To evaluate adverse events [initial safety] of UCon for treatment of OAB symptoms in a home setting.
Time frame: After 44 days (end of study)
Characterization of adverse events and anticipated adverse device effects associated with the use of UCon during the investigational period.
PRIMARY PERFORMANCE: To evaluate the ratio of treatment change [performance] of OAB symptoms using UCon in a home setting
Time frame: Change from baseline at 14 days, 30 days and 44 days (study end)
Ratio of subjects with at least 50% change in their OAB symptoms from baseline. Participants shall complete a 3-day bladder diary to report their symptoms. The symptoms related to OAB: * 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.
5 secondary outcomes
SECONDARY SAFETY: To identify the number of subjects experiencing adverse events associated with the use of UCon during the investigational period.
Time frame: After 44 days (end of study)
SECONDARY SAFETY: To evaluate the severity of adverse events associated with the use of UCon during the investigational period.
Time frame: After 44 days (study end)
SECONDARY PERFORMANCE: To evaluate whether subjects using UCon experience a change in their quality of life.
Time frame: Change from baseline at 14 days and 44 days (end of study)
SECONDARY PERFORMANCE: To evaluate whether subjects using UCon experience a change in their treatment outcome (i.e. symptoms) after therapy.
Time frame: Change from baseline at 14 days and 44 days (end of study)
SECONDARY PERFORMANCE: To evaluate the device and treatment acceptability of UCon.
Time frame: After 44 days (study end)
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 6 Nov 2026.
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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.
John Heesakkers, MD principal investigator
Maastricht UMC+, P. Debyelaan 25, 6229 HX Maastricht, The Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urge stimulation and Time limited stimulation in people with Urinary Incontinence and Urge Incontinence, run by InnoCon Medical at 1 site in Netherlands.
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 4 inclusion and 12 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 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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. 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?
PRIMARY SAFETY: To evaluate adverse events [initial safety] of UCon for treatment of OAB symptoms in a home setting. (time frame: After 44 days (end of study)). The study lists 2 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 6 Nov 2026.