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Active, Not Recruiting

NCT Number: NCT06597994

Augmenting Urinary Reflex Activity: Study 3

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Antwerp

Antwerp, 2650, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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  • Participant has withdrawn from AURA-2 clinical investigation.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).

Treatment and study plan

Amber UI system

Device

Upgrade of Amber UI system recharge accessories and system firmware

Primary outcomes

  1. Change in absolute recharge performance

    Time frame: 48 hours; 2 weeks; 2 months; 2 months + 1 week; 4 months; 8 months

    Change in perceived recharge usability before and after receiving new recharge accessories and training.

  2. Change in relative recharge performance

    Time frame: 48 hours; 2 weeks; 2 months; 2 months + 1 week; 4 months; 8 months

    Relative (percentage) change in frequency and duration of recharging sessions after receiving new recharge accessories and training compared to baseline.

Secondary outcomes

  1. Change in recharge usability

    Time frame: 48 hours; 2 weeks; 2 months; 2 months + 1 week; 4 months; 8 months

    % of time the device is fully operational and available for use after receiving new recharge accessories and training compared to baseline

  2. Fully adaptive mode usability

    Time frame: 48 hours; 2 months; 8 months

    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.

  3. Fully adaptive mode specificity

    Time frame: 48 hours; 2 months; 8 months

    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.

  4. Adverse Device Events

    Time frame: 48 hours; 2 weeks; 2 months; 2 months + 1 week; 4 months; 8 months

    Incidence of adverse events as defined by REGULATION (EU) 2017/745(MDR) and MDCG 2020-10/1

Sponsors and collaborators

Lead sponsor

Amber Therapeutics Ltd

Industry

Registry information

Official study title

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

Acronym: AURA-3

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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