Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2023-10-12
2026-06-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Group A (Urge and Time limited)
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.
Urge stimulation
Participants will receive stimulation for 60 seconds, when they feel an urgency.
Time limited stimulation
Participant will receive the stimulation as provided in time limited sessions (Range: 15 min - continuous), whenever it suits the participant during the day.
Group B (Time limited and Urge)
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.
Urge stimulation
Participants will receive stimulation for 60 seconds, when they feel an urgency.
Time limited stimulation
Participant will receive the stimulation as provided in time limited sessions (Range: 15 min - continuous), whenever it suits the participant during the day.
Interventions
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Urge stimulation
Participants will receive stimulation for 60 seconds, when they feel an urgency.
Time limited stimulation
Participant will receive the stimulation as provided in time limited sessions (Range: 15 min - continuous), whenever it suits the participant during the day.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subject is male.
3. Subject is diagnosed with OAB
4. Subject is able to communicate, provide feedback, understand and follow instructions during the course of the investigation.
Exclusion Criteria
2. 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)).
3. Subject has an active infection in the genital area incl. skin infections and urinary tract infection.
4. Subject has had botulinum toxin (BOTOX) treatment in the pelvic region within 6 months.
5. Subject has used antimuscarinics or β3 agonists within 14 days weeks\*.
6. 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).
7. 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.
8. Subject has neuropathy to a degree that is presumed to diminish the effect of the electrical stimulation.
9. Subject has a history of cancer in the pelvic region, are currently receiving cancer treatment, or has radiation-induced damage to the pelvic region.
10. Subject has addictive behaviour defined as abuse of alcohol, cannabis, opioids, or other intoxicating drugs.
11. 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.
18 Years
MALE
No
Sponsors
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InnoCon Medical
INDUSTRY
Responsible Party
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Principal Investigators
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John Heesakkers, MD
Role: PRINCIPAL_INVESTIGATOR
Maastricht UMC+, P. Debyelaan 25, 6229 HX Maastricht, The Netherlands
Locations
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Maastricht University Medical Center+
Maastricht, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NL_FEAS_01
Identifier Type: -
Identifier Source: org_study_id
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