Overactive bladder Urgency-frequency
Conditions
Interventions
The intervention of this clinical investigation is neuromodulation obtained by
electrical stimulation via UCon.
The subjects apply electrical stimulation 2 x 14 days. The cross-over design of
the s
Sponsors
InnoCon Medical ApS
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - 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.
Exclusion criteria
Exclusion criteria: 1. Subject is medically unstable (acute illness or complications of a chronic condition that might affect the subject*s participation in the investigation). 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 UTI. 4. Subject has had botulinum toxin (BOTOX) treatment in the pelvic region within 6 months. 5. Subject has used antimuscarinics or ß3 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 is currently receiving cancer treatment or has radiation-induced damage to the pelvic region** 10. Subject does not have an intact sensation to urinate. 11. Subject has addictive behaviour defined as abuse of alcohol, cannabis, opioids, or other intoxicating drugs. 11. Subject does not speak or does not understand Dutch. *If a subject is currently being treated with antimuscarinics or ß3 agonists, he is allowed to be included in the investigation, however, a washout period of 14 days is required before baseline can be established.** If it is suspected that the subject does not have an intact DGN, he shall pass a DGN sensation test (sensation in the glans penis during DGN stimulation at the root of the penis) to be included in the investigation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Safety Endpoint • Characterization of adverse events and anticipated adverse device effects associated with the use of UCon. Primary Performance Endpoint • Ratio of subjects with at least 50% improvement of their OAB symptoms from baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Safety Endpoint • Frequency and severity of all adverse events and anticipated adverse device effects associated with the use of UCon. Secondary Performance Endpoint • Ratio of subjects with improvement in their OAB specific quality of life measures from baseline. • Ratio of subjects that accept UCon and DGN stimulation. | — |
Countries
Netherlands
Contacts
Public ContactDMK Knudsen
Medical Device Company
Outcome results
None listed