Exploratory Safety and Feasibility Study of Personalized Adaptive Pudendal Neuromodulation for Mixed Urinary Incontinence and Extended Indications Using an Implanted Picostim II System

What this Trial Is About

Researchers are evaluating the safety and feasibility of a personalized adaptive pudendal neuromodulation system called Picostim II for women experiencing mixed urinary incontinence and related conditions. This exploratory study focuses on women aged 22 years and older who have not responded to or tolerated conservative treatments for urinary incontinence symptoms lasting at least six months. The study includes participants with mixed urinary incontinence and those with extended indications such as stress urinary incontinence, urge urinary incontinence, and chronic pelvic pain. All participants will receive the Amber UI system, an implanted device designed to provide pudendal neuromodulation. The study involves two groups one with mixed urinary incontinence and another with extended indications. The device is implanted and personalized to each participants needs, with follow-up and monitoring scheduled over 12 months. Researchers will observe procedural and device-related safety, device deficiencies, and the need for any surgical reintervention during this period. Participants will undergo various assessments including changes in urinary distress, frequency of urinary events, pad test weight, quality of life, anxiety, and health questionnaires over the course of 12 months. The primary safety outcomes focus on adverse events related to the procedure and device. Follow-up visits will help track the devices use, participant adherence, and overall health status. The total study duration for each participant includes baseline evaluation and monitoring over a year after implantation.

Augmenting Urinary Reflex Activity Study 4 (Including eXtended Indications)