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

Urinary Incontinence Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 20 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06091566
Study type Interventional
Source InnoCon Medical
Contact Dianna Mærsk Knudsen
Phone 40517712
Email dmk@innoconmedical.dk
Status Recruiting
Phase N/A
Start date January 12, 2024
Completion date January 1, 2026
View Details
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