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UCon Treatment of Overactive Bladder (OAB) in Males

NCT05874375 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-10-01

No results posted yet for this study

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.

Conditions

  • Urinary Incontinence
  • Urge Incontinence
  • Nocturia
  • Urinary Frequency More Than Once at Night
  • Urinary Incontinence, Urge
  • Incontinence, Nighttime Urinary

Interventions

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.

Sponsors & Collaborators

  • InnoCon Medical

    lead INDUSTRY

Principal Investigators

  • John Heesakkers, MD · Maastricht UMC+, P. Debyelaan 25, 6229 HX Maastricht, The Netherlands

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-12
Primary Completion
2026-06-12
Completion
2026-06-12

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05874375 on ClinicalTrials.gov