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

NCT05368246 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-02-05

No results posted yet for this study

Summary

This clinical investigation is a single-arm, prospective, multicentre, early feasibility study, which is used to evaluate the device design of UCon with respect to initial clinical safety and device performance in a small number of subjects. UCon is a medical device for treatment of the symptoms of overactive bladder (OAB) and bowel disorders (BD). It electrically stimulates the dorsal genital nerve (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.

Conditions

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

Interventions

DEVICE

UCon

The subjects self-administer electrical stimulation to the dorsal genital nerve (DGN) for 4 weeks using UCon

Sponsors & Collaborators

  • Aarhus University Hospital

    collaborator OTHER

  • Herlev Hospital

    collaborator OTHER

  • Odense University Hospital

    collaborator OTHER

  • InnoCon Medical

    lead INDUSTRY

Principal Investigators

  • Peter Christensen · 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
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-15
Primary Completion
2024-01-15
Completion
2024-01-15

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 NCT05368246 on ClinicalTrials.gov