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

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)

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)

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

Clinical Briefing

Clinical Editorial

Source Reference

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