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Safety and Performance of UCon Bar Electrode for the Treatment of Overactive Bladder (OAB) and Bowel Dysfunction (BD)

NCT06091566 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-02-18

No results posted yet for this study

Summary

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

This clinical investigation is designed as a single-arm, prospective, multi-centre, and early feasibility study.

Conditions

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

Interventions

DEVICE

UCon-Bar

The participant self-administer electrical stimulation to the dorsal genital nerve (DGN) for either 4 weeks or 12 weeks using UCon with the Bar 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
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-12
Primary Completion
2027-01-01
Completion
2027-01-01

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 NCT06091566 on ClinicalTrials.gov