Clinical Trial

Augmenting Urinary Reflex Activity Study 4 (Including eXtended Indications)

Study acronym: AURA-4X
Recruiting
View on ClinicalTrials.gov →
Summary
Exploratory safety and feasibility study of personalized adaptive pudendal neuromodulation for mixed urinary incontinence and extended indications using an implanted (Picostim™ II) system.
Protocol Amendment History 3 changes
notable Enrollment increased: 56 -> 86 participants 2026-05-16
notable Primary completion pushed: 2027-02 -> 2027-06 2026-05-16
minor Completion pushed: 2029-08 -> 2030-01 2026-05-16
Trial Details
NCT Number NCT06885931
Lead Sponsor Amber Therapeutics Ltd
Conditions Mixed Urinary Incontinence, Stress Urinary Incontinence (SUI), Chronic Pelvic Pain, Urge Urinary Incontinence
Enrollment 86 participants
Start Date 2025-06-24
Primary Completion 2027-06 (estimated)
Study Completion 2030-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-15