NCT05864807

UCon Treatment of the Symptoms of Faecal Incontinence (FI)

Safety and Performance of UCon for the Treatment of the Symptoms of Faecal Incontinence (FI) - An Early Feasibility Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: InnoCon Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The overall purpose of the current clinical investigation is to evaluate the medical device (UCon) with respect to initial safety and device performance in a cohort of Spanish patients with FI over a treatment period of 4 weeks.

Conditions

• Faecal Incontinence
• Faecal Incontinence With Faecal Urgency

Interventions

Type	Name	Description
DEVICE	UCon	The participant self-administer electrical stimulation to the dorsal genital nerve (DGN) for 4 weeks using UCon

Timeline

• Start date: 2023-08-01
• Primary completion: 2026-02-02
• Completion: 2026-02-02
• First posted: 2023-05-18
• Last updated: 2026-02-18

Locations

1 site across 1 country: Spain