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Safety and Performance of UCon Patch Electrode

NCT06754189 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2025-03-27

No results posted yet for this study

Summary

UCon is a medical device for treating the symptoms of overactive bladder (OAB) and bowel dysfunction (BD). It electrically stimulates the DGN through the skin to obtain modulated behavior of the bladder/bowel musculature e.g., suppressing undesired bladder/bowel activity to relieve the symptoms of the patient.

This pivotal clinical investigation is designed as a stratified-randomized, single-blinded, controlled, confirmatory, prospective, multicenter clinical investigation.

Conditions

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

Interventions

DEVICE

Time Limited stimulation

The participant self-administer 30 min. of electrical stimulation using Time Limited stimulation to the dorsal genital nerve (DGN) for 6 weeks using UCon with the UCon-Patch electrode.

DEVICE

Sham stimulation

The participant self-administer 30 min. of sham stimulation to the dorsal genital nerve (DGN) for 6 weeks using a sham device with the UCon-Patch electrode.

Sponsors & Collaborators

  • Aarhus University Hospital

    collaborator OTHER

  • Odense University Hospital

    collaborator OTHER

  • Herlev Hospital

    collaborator OTHER

  • InnoCon Medical

    lead INDUSTRY

Principal Investigators

  • Peter Christensen, MD · Palle Juul Jensens Boulevard 99 DK-8200 Aarhus N

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-20
Primary Completion
2028-03-20
Completion
2028-03-20

Countries

  • Denmark

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 NCT06754189 on ClinicalTrials.gov