Augmenting Urinary Reflex Activity: Study 3

NCT ID: NCT06597994

Last Updated: 2025-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-15

Study Completion Date

2026-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Urinary Incontinence

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single Group Assignment
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Amber UI Therapy

Participants will receive optimised recharge accessories and device firmware upgrades

Group Type EXPERIMENTAL

Amber UI system

Intervention Type DEVICE

Upgrade of Amber UI system recharge accessories and system firmware

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Amber UI system

Upgrade of Amber UI system recharge accessories and system firmware

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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* Participant has withdrawn from AURA-2 clinical investigation.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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Amber Therapeutics Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Stefan De Wachter, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Antwerp

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital Antwerp

Antwerp, , Belgium

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TS-01388

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

InterStim® Amplitude Study
NCT03335761 COMPLETED NA
Uro-NIRS Clinical Study
NCT00706407 COMPLETED NA