Safety and Performance of UCon Bar Electrode for OAB and Bowel Dysfunction

18 Feb 20264 min read0 viewsINTERVENTIONAL Trial

GIST

Official title: Safety and Performance of UCon Bar Electrode for the Treatment of Overactive Bladder (OAB) and Bowel Dysfunction (BD) - An Early Feasibility Study 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. 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 Keywords: Urinary Incontinence, Fecal Incontinence, Urge incontinence, Neurostimulation, Dorsal Genital Nerve Study type: INTERVENTIONAL Primary purpose: TREATMENT Phases: NA Enrollment: 20 (ESTIMATED) Status: RECRUITING Completion: 2027-01-01 (ESTIMATED)

Clinical Editorial

Investigational Focus and Study Intent

The UCon Bar Electrode is evaluated for treating overactive bladder (OAB) and bowel dysfunction (BD) by electrically stimulating the dorsal genital nerve (DGN) through the skin.
The goal is to modulate bladder and bowel musculature to suppress undesired activity and alleviate symptoms.

Study Design and Population

Design: single-arm, prospective, multi-centre, early feasibility study.
Population and conditions addressed include urinary incontinence (urge-type) and fecal incontinence with associated symptoms such as fecal urgency, nocturia, nighttime urinary frequency, and broader bowel disorders.
Target enrollment is 20 participants (estimated).

Intervention and Exposure

Intervention consists of the UCon Bar Electrode device delivering cutaneous stimulation to the DGN to influence lower urinary and bowel function.

Primary Objective and Phase Context

Primary purpose is treatment-oriented, aligned with early feasibility assessment of safety and performance.
Formal phase designation is not specified beyond “early feasibility.”