Safety and Performance of UCon for the Treatment of the Symptoms of Faecal Incontinence (FI) - An Early Feasibility Study
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
UCon is a medical device for treatment of the symptoms of overactive bladder and fecal incontinence (FI). 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, single-centre, early feasibility study.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Participant is ≥ 18 years of age.
• Participant is showing symptoms of FI.
• Participant is able to communicate, provide feedback, understand and follow instructions during the course of the investigation, including using the device at home.
Locations
Other Locations
Spain
Vall d'Hebron University Hospital
RECRUITING
Barcelona
Contact Information
Primary
Dianna Mærsk Knudsen
dmk@innoconmedical.dk
+4540517712
Time Frame
Start Date: 2023-08-01
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 30
Treatments
Experimental: Interventional arm
Electrical stimulation to the dorsal genital nerve.
Related Therapeutic Areas
Sponsors
Leads: InnoCon Medical