Safety and Performance of UCon Patch Electrode

NARecruitingINTERVENTIONAL
Enrollment

180

Participants

Timeline

Start Date

March 20, 2025

Primary Completion Date

March 20, 2028

Study Completion Date

March 20, 2028

Conditions
Urinary IncontinenceUrinary Incontinence, UrgeNocturiaUrinary Frequency More Than Once at NightUrinaryIncontinence, Nighttime UrinaryFecal IncontinenceFecal 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.

Trial Locations (3)

2730

RECRUITING

Herlev Hospital, Herlev

5000

RECRUITING

Odense University Hospital, Odense

8200

RECRUITING

Aarhus University Hospital, Aarhus

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Aarhus University Hospital

OTHER

collaborator

Odense University Hospital

OTHER

collaborator

Herlev Hospital

OTHER

lead

InnoCon Medical

INDUSTRY