NCT06091566

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

Safety and Performance of UCon Bar Electrode for the Treatment of Overactive Bladder (OAB) and Bowel Dysfunction (BD) - An Early Feasibility Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: InnoCon Medical · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The overall purpose of the current clinical investigation is to evaluate the medical device with a UCon-Bar Electrode with respect to its initial safety and device performance in a cohort of 40 female patients with OAB/BD over a period of 12 weeks. The investigation consists of two periods: a screening period and an intervention period. During the screening period, the participants will be using UCon with a Patch Electrode and complete a 4 week stimulation period at home. The screening period will determine if participants fulfil the criteria to participate in the intervention period. During the intervention period, the UCon Bar Electrode will be inserted in the clitoral hood. After a recovery period (4-8 weeks), the participants will be using UCon with the Bar Electrode and complete wither a 4 week or a 12 week stimulation period at home.

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

Type	Name	Description
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

Timeline

• Start date: 2024-01-12
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2023-10-19
• Last updated: 2026-02-18

Locations

3 sites across 1 country: Denmark