Trials / Recruiting
RecruitingNCT05874375
UCon Treatment of Overactive Bladder (OAB) in Males
Safety and Performance of UCon for Management of Non-Neurogenic OAB in Males - An Early Feasibility Study
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- Sponsor
- InnoCon Medical · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Urge stimulation | Participants will receive stimulation for 60 seconds, when they feel an urgency. |
| DEVICE | 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. |
Timeline
- Start date
- 2023-10-12
- Primary completion
- 2026-06-12
- Completion
- 2026-06-12
- First posted
- 2023-05-24
- Last updated
- 2025-10-01
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT05874375. Inclusion in this directory is not an endorsement.