Urinary IncontinenceAURA-3NCT06597994
Augmenting Urinary Reflex Activity: Study 3
A study testing Amber UI system in people with Urinary Incontinence, run by Amber Therapeutics Ltd at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Amber UI system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Jan 2025to 8 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant has exited the AURA-2 clinical investigation.
- Participant has an implanted Amber UI system.
- Consents to participation.
Who cannot join
- Participant has withdrawn from AURA-2 clinical investigation.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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Urinary Incontinence
- Being tested
- Amber UI system
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amber UI systemDevice
Upgrade of Amber UI system recharge accessories and system firmware
| Study group | Role | What they receive |
|---|---|---|
| Amber UI Therapy | Experimental | Participants will receive optimised recharge accessories and device firmware upgrades Receives: Device: Amber UI system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in absolute recharge performance
Change in perceived recharge usability before and after receiving new recharge accessories and training.
Measured: 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.
Measured: 48 hours; 2 weeks; 2 months; 2 months + 1 week; 4 months; 8 months
Secondary outcomes (4)
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
Measured: 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.
Measured: 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.
Measured: 48 hours; 2 months; 8 months
Adverse Device Events
Incidence of adverse events as defined by REGULATION (EU) 2017/745(MDR) and MDCG 2020-10/1
Measured: 48 hours; 2 weeks; 2 months; 2 months + 1 week; 4 months; 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start15 Jan 2025
- Primary completion27 Jun 2025
- Study completion8 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amber Therapeutics Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stefan De Wachter, MD, Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06597994
- Sponsor's protocol ID
- TS-01388
- Acronym
- AURA-3
- Status last verified
- Oct 2026
- First submitted
- 9 Aug 2024
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapy Optimisation Study of Adaptive Pudendal Neuromodulation in Women With Urinary Incontinence Implanted With the Amber UI System.
- ClinicalTrials.gov ID
- NCT06597994
- Acronym / sponsor ID
- AURA-3 / TS-01388
- Conditions
- Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Amber Therapeutics LtdIndustry (pharma, biotech, devices)
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 27 Jun 2025 (actual)
- Study completion
- 8 Dec 2025 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| Amber UI Therapy | Experimental | Device: Amber UI systemParticipants will receive optimised recharge accessories and device firmware upgrades |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participant has exited the AURA-2 clinical investigation.
- Participant has an implanted Amber UI system.
- Consents to participation.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amber UI systemUpgrade of Amber UI system recharge accessories and system firmware | Device | Amber UI Therapy |
Primary outcome
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.
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.
4 secondary outcomes
Change in recharge usability
Time frame: 48 hours; 2 weeks; 2 months; 2 months + 1 week; 4 months; 8 months
Fully adaptive mode usability
Time frame: 48 hours; 2 months; 8 months
Fully adaptive mode specificity
Time frame: 48 hours; 2 months; 8 months
Adverse Device Events
Time frame: 48 hours; 2 weeks; 2 months; 2 months + 1 week; 4 months; 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan De Wachter, MD principal investigator
University Hospital, Antwerp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amber UI system in people with Urinary Incontinence, run by Amber Therapeutics Ltd at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in absolute recharge performance (time frame: 48 hours; 2 weeks; 2 months; 2 months + 1 week; 4 months; 8 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.