NCT06597994

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

January 15, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

May 15, 2025

Status Verified

May 1, 2025

Enrollment Period

12 months

First QC Date

August 9, 2024

Last Update Submit

May 14, 2025

Conditions

Urinary Incontinence

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Secondary Outcomes (4)

  • Change in recharge usability

    48 hours; 2 weeks; 2 months; 2 months + 1 week; 4 months; 8 months

  • Fully adaptive mode usability

    48 hours; 2 months; 8 months

  • Fully adaptive mode specificity

    48 hours; 2 months; 8 months

  • Adverse Device Events

    48 hours; 2 weeks; 2 months; 2 months + 1 week; 4 months; 8 months

Study Arms (1)

Amber UI Therapy

EXPERIMENTAL

Participants will receive optimised recharge accessories and device firmware upgrades

Device: Amber UI system

Interventions

Amber UI systemDEVICE

Upgrade of Amber UI system recharge accessories and system firmware

Amber UI Therapy

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Antwerp

Antwerp, 2650, Belgium

Location

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Stefan De Wachter, MD

    University Hospital, Antwerp

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single Group Assignment
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2024

First Posted

September 19, 2024

Study Start

January 15, 2025

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

May 15, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)