AURA 4X: Augmenting Urinary Reflex Activity Study 4
Research type
Research Study
Full title
Exploratory safety and feasibility study of personalised adaptive pudendal neuromodulation for mixed urinary incontinence and extended indications using an implanted (Picostim II™) system
IRAS ID
356095
Contact name
Mahreen Pakzad
Contact email
Sponsor organisation
Amber Therapeutics
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 0 months, 0 days
Research summary
This multicentre, prospective, interventional, dual cohort study of a medical device aims to explore safety and feasibility of personalised adaptive pudendal neuromodulation for mixed urinary incontinence (MUI) and extended indications using an implanted (Picostim™ II) system.
The Picostim™ II system is a bioelectronics-enabled system designed to address the dynamic and multifaceted needs of mixed urinary incontinence (MUI). The Picostim II technology integrates advanced neurostimulation with embedded sensing and adaptive algorithms to mimic and/or reinforce the body’s natural reflexes. By leveraging the principles of bioelectronics, the device intelligently detects physiological signals and translates them into therapeutic responses, providing an unparalleled level of personalised therapy. The therapy is referred to as AURA: Augmenting Urinary Reflex Activity, based on this principle of operation.
The (Amber) Picostim II system is indicated for the treatment of adult women (defined as ≥ 22 years of age) with urinary incontinence (UI) whose symptoms comprise both urge and stress UI episodes (also called mixed urinary incontinence), and who have failed to respond to or could not tolerate conservative treatment.
The AURA-4X study includes patients meeting criteria aligned to this indication for use but also the stated study-specific extended indications: stress urinary incontinence (SUI), Urge Urinary Incontinence (UUI) and chronic pelvic pain (CPP). In addition, AURA-2 patients have a mix of indications including MUI, but also refractory urge urinary incontinence (UUI). These patients are included as a separate cohort, Cohort B, within the dual cohort study design.
The study will be conducted across 5-6 centres in the UK and European Union (Belgium and The Netherlands). Enrolment of Cohort B patients (extended indications) will occur in Belgium only. The UK will enrol Cohort A (MUI) patients only.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
25/YH/0247
Date of REC Opinion
19 Dec 2025
REC opinion
Further Information Favourable Opinion