Augmenting Urinary Reflex Activity: Study 3 (AURA-3)

Therapy Optimisation Study of Adaptive Pudendal Neuromodulation in Women With Urinary Incontinence Implanted With the Amber UI System.

AURA-3 study (Augmenting Urinary Reflex Activity Study 3) is a single arm, short-duration (8 month) cohort follow up study of preceding interventional medical device study, AURA-2.

Study Overview

• Status: Active, not recruiting
• Conditions: Urinary Incontinence
• Intervention / Treatment: Device: Amber UI system

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Antwerp, Belgium, 2650
    • University Hospital Antwerp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participant has exited the AURA-2 clinical investigation.
• Participant has an implanted Amber UI system.
• Consents to participation.

Exclusion Criteria:

• Participant has withdrawn from AURA-2 clinical investigation.
• Participant is pregnant.
• A past or current condition that in the opinion of the PI contraindicates enrolment (PI discretion).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Amber UI Therapy; Participants will receive optimised recharge accessories and device firmware upgrades	Device: Amber UI system; Upgrade of Amber UI system recharge accessories and system firmware

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in relative recharge performance	Relative (percentage) change in frequency and duration of recharging sessions after receiving new recharge accessories and training compared to baseline.	48 hours; 2 weeks; 2 months; 2 months + 1 week; 4 months; 8 months
Change in absolute recharge performance	Change in perceived recharge usability before and after receiving new recharge accessories and training.	48 hours; 2 weeks; 2 months; 2 months + 1 week; 4 months; 8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in recharge usability	% of time the device is fully operational and available for use after receiving new recharge accessories and training compared to baseline	48 hours; 2 weeks; 2 months; 2 months + 1 week; 4 months; 8 months
Adverse Device Events	Incidence of adverse events as defined by REGULATION (EU) 2017/745(MDR) and MDCG 2020-10/1	48 hours; 2 weeks; 2 months; 2 months + 1 week; 4 months; 8 months
Fully adaptive mode usability	Change in frequency, severity and impact on quality of life of urinary incontinence episodes as assessed by Short Form version of the International Consultation on Incontinence urinary questionnaire (ICIQ-UI SF) after receiving fully adaptive firmware update and training compared to baseline. The ICIQ-UI SF is a 4 item simple questionnaire with minimum value of 0 and maximum value of 21 with higher scores indicating higher severity of UI symptoms and their impact on health-related quality of life.	48 hours; 2 months; 8 months
Fully adaptive mode specificity	Change in quality of life in relation to change in obstructive symptoms, irritative symptoms and stress symptoms as assessed by the Long Form version of the Urogenital Distress Inventory (UDI-LF) after receiving fully adaptive firmware update and training compared to baseline. The UDI-LF consists of 19 questions and total scores are converted to a score range of 0-300, with higher scores representing greater symptom distress.	48 hours; 2 months; 8 months

Collaborators and Investigators

• Sponsor: Amber Therapeutics Ltd
• Investigators: Principal Investigator: Stefan De Wachter, MD, University Hospital, Antwerp

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2025
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: August 9, 2024
• First Submitted That Met QC Criteria: September 13, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): May 15, 2025
• Last Update Submitted That Met QC Criteria: May 14, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Mental Disorders; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Behavioral Symptoms; Elimination Disorders; Urinary Incontinence; Enuresis
• Other Study ID Numbers: TS-01388

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No