Safety and Performance of UCon for Management of Non-Neurogenic OAB in Males - An Early Feasibility Study
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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. 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.
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Netherlands
Maastricht University Medical Center+
RECRUITING
Maastricht
Contact Information
Primary
Dianna Mærsk Knudsen
dmk@innoconmedical.dk
40517712
Time Frame
Start Date: 2023-10-12
Estimated Completion Date: 2026-06-12
Participants
Target number of participants: 20
Treatments
Other: 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.
Other: 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.
Related Therapeutic Areas
Sponsors
Leads: InnoCon Medical