Safety and Performance of UCon for Management of Non-Neurogenic OAB in Males - An Early Feasibility Study

Recruiting

• Conditions: Overactive bladder; Urgency-frequency; 10004994

• Registration Number: NL-OMON53594
• Lead Sponsor: InnoCon Medical ApS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 20

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

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 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Safety Endpoint<br /><br>• Characterization of adverse events and anticipated adverse device effects<br /><br>associated with the use of UCon.<br /><br><br /><br>Primary Performance Endpoint<br /><br>• Ratio of subjects with at least 50% improvement of their OAB symptoms from<br /><br>baseline.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary Safety Endpoint<br /><br>• Frequency and severity of all adverse events and anticipated adverse device<br /><br>effects associated with the use of UCon.<br /><br>Secondary Performance Endpoint<br /><br>• Ratio of subjects with improvement in their OAB specific quality of life<br /><br>measures from baseline.<br /><br>• Ratio of subjects that accept UCon and DGN stimulation.</p><br>