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Overactive BladderAURA-2NCT05241379

AURA-2: Augmenting Urinary Reflex Activity

A study testing Amber UI System in people with Overactive Bladder and Urge Incontinence, run by Amber Therapeutics Ltd at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

AMBER AURA-2 study (Augmenting Urinary Reflex Activity 2) is a short-duration (6 month) safety and electrophysiological study using an implanted Amber UI system and two electrode leads to provide closed-loop pudendal nerve stimulation for the treatment of urinary incontinence. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Overactive Bladder, Urge 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
13 participants
Where
1 siteBelgium
Study dates
30 Nov 2022to 15 Apr 2024
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

  • Female patients aged ≥ 18 years
  • Diagnosis of urinary incontinence, with on a 5-day voiding diary at least 1 daily urgency episode and/or greater than or equal to 8 voids/day and/or by having a minimum of two involuntary leaking episodes in 72 hr
  • Duration of urinary incontinence symptom ≥ 6 months prior to the screening baseline visit date
  • Failed or is not a candidate for more conservative treatment e.g. pelvic floor muscle therapy or biofeedback or behavioral modification
  • Failed or could not tolerate at least one (1) antimuscarinic or beta3-adrenoceptor agonist medication
  • Urodynamic testing (uroflowmetry, cystometry and pressure flow) completed within 12 months prior to screening baseline visit date or is willing to have testing at screening baseline visit
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  • Cystoscopy test completed within 12 months prior to the screening baseline visit date or is willing to have a test at screening baseline visit
  • Is willing and able to washout from OAB medications for at least 4 week prior to beginning the baseline voiding diary
  • Ability and willingness to give informed consent including language constraints (see above)
  • Able to participate in all testing and follow-up clinic visits associated with study protocol
  • Capable of independently using the system components (after training) as described in the Patient Manual
  • Mobile and able to use toilet without assistance

Who cannot join

  • General:
  • Patient is pregnant, breastfeeding, or plans to become pregnant during the course of the study (pregnancy tests provided in schedule)
  • Patient is unwilling or unable to use contraception during sexual intercourse for the duration of the study, and thereafter if implant remains in the longer term.
  • Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound evaluation of study endpoints
  • Any psychiatric or personality disorder at the discretion of the study physician
  • Any neurological condition that may interfere with normal bladder function (e.g., stroke, multiple sclerosis, Parkinson's disease; clinically significant peripheral neuropathy, or complete spinal cord injury)
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  • Patient has uncontrolled type I or type II diabetes as defined by their routine care clinician or diabetes with peripheral nerve involvement
  • Any history of any pelvic cancer
  • Patient has history of other non-pelvic neoplasia within 5 years prior to enrolment, except for a cancer that was determined to be local occurrence only, such as basal cell carcinoma, or is receiving or planning to receive anti-cancer or anti-angiogenic drugs
  • Patient has proven major autoimmune disease, e.g. scleroderma or immunodeficiency (including use of biologic immunomodulatory drugs at time of procedure)
  • Life expectancy of less than 1 year
  • Patient is a frail elderly and/or with notable clinical evidence of sarcopaenia
  • Patient is not suitable for the study as determined by their routine care physician for any other reason
  • Patient is enrolled in another interventional study excepting observational studies, e.g. SNM registries or in relation to disease (see below)
  • Patient participation in vigorous sporting activities where these cannot be restricted for a period of 6 weeks post-implantation.
  • Specific urological
  • Urinary tract mechanical obstruction such as urethral stricture
  • Current symptomatic urinary tract infection (UTI) or more than 3 UTIs in past year
  • Pure stress incontinence or mixed incontinence where the stress component overrides the urge component
  • Interstitial cystitis or bladder pain syndrome as defined by either AUA or EAU guidelines
  • Suspected pudendal nerve entrapment syndrome. In patients with co-existent symptoms of chronic pelvic pain and urinary incontinence, Nantes criteria will be used for screening. Patients meeting essential criteria will be excluded from the study
  • Treatment of urinary symptoms with botulinum toxin therapy in the past 12 months
  • Prior attempt at pudendal nerve stimulation using an implanted lead
  • Treatment of urinary symptoms with tibial or sacral nerve stimulation in the past 3 months (prior experience of either before this time is permitted provided no implants remain in-situ)
  • Specific technical
  • Patient is significantly obese (defined as BMI ≥ 35) so as to limit electrode lead placement using standard approaches
  • Skin, orthopaedic or neurological anatomical limitations that could prevent successful placement of the electrode lead
  • Knowledge of planned MRIs, diathermy, microwave exposure, high output ultrasonic exposure, or RF energy exposure
  • Implantable neurostimulator, pacemaker or defibrillator in situ (anywhere in body including sacral and tibial)
  • Subject with a documented history of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • University Hospital Antwerp

    Antwerp, 2650

Other trials in Belgium

About this study

Official title: Exploratory Safety and Electrophysiological Study of Closed-loop Pudendal Neuromodulation Using an Implantable (Picostim-DyNeuMo) Device in Women With Urinary Incontinence

AMBER AURA-2 study (Augmenting Urinary Reflex Activity 2) is a short-duration (6 month) safety and electrophysiological study using an implanted Amber UI system and two electrode leads to provide closed-loop pudendal nerve stimulation for the treatment of urinary incontinence.

Being tested
Amber UI System
Medical subject headings
Urinary Bladder, Overactive, Urinary Incontinence, Urge

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Amber UI SystemDevice

    The implantable components of the Amber UI system consist of an implantable pulse generator (Picostim Amber IPG), 2 electrode leads with anchoring system

Study groups in NCT05241379
Study groupRoleWhat they receive
Amber UI TherapyExperimentalParticipants will undergo surgical implantation of the Amber UI System incorporating 2 electrode leads connected to a single IPG
Receives: Device: Amber UI System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse Device Events

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

    Measured: 24 hours; 1 week; 4 weeks; 3 months; 6 months

Secondary outcomes (7)

  1. Changes in Voiding diary data

    Changes in 5 days voiding diary data including number of incontinence episodes, number of voids, number of urgency episodes

    Measured: Baseline, 28 days, 3 months, 6 months

  2. Changes in ICIQ -UI Short Form

    ICIQ-SF-UI questionnaire: is a questionnaire for evaluating frequency, severity and impact on quality of life of urinary incontinence in research and clinical practice. It is a 4 item simple questionnaire

    Measured: Baseline, 28 days, 3 months, 6 months

  3. Changes in ICIQ-OAB Quality of Life

    ICIQ-OAB Qol questionnaire: is a robust, subject-completed questionnaire for evaluating quality of life (QoL) in subjects with overactive bladder, for use in research and clinical practice. The questionnaire explores in detail the impact on subject's lives of overactive bladder and can be used as an outcome measure to assess impact of different

    Measured: Baseline, 28 days, 3 months, 6 months

  4. Changes in PGI-I

    Patient Global Impression of Improvement (PGI-I): The PGI-I is a subject-completed transition scale that is a single question asking the subject to rate their urinary tract condition now, as compared with how it was prior to before beginning treatment on a 7 point scale

    Measured: Baseline, 28 days, 3 months, 6 months

  5. Changes in FSFI

    FSFI - questionnaire: The Female Sexual Function Index (FSFI) is a widely used multidimensional self-reported questionnaire on Female Sexual Dysfunction. It consists of 19 items and assesses 6 domains, including desire, arousal, lubrication, orgasm, satisfaction and pain.

    Measured: Baseline, 28 days, 3 months, 6 months

  6. Technical Outcomes

    Number of patients successfully implanted

    Measured: 24 hours postoperatively

  7. Measurement of EMG

    Intra-operative and post-operative (ambulatory) measurements of electromyography

    Measured: During procedure, 24 hours and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2022
  2. Study start30 Nov 2022
  3. Primary completion15 Apr 2024
  4. Study completion15 Apr 2024

Resources

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
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05241379
Sponsor's protocol ID
Amber AURA-2
Acronym
AURA-2
Status last verified
Aug 2024
First submitted
24 Jan 2022
Last updated
12 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Herroelen S, Knowles CH, Doherty S, Benjaber M, Kerr J, Wendt K, Crawley A, Denison T, De Wachter S. Adaptive Pudendal Nerve Stimulation: A Pilot Study on Safety, Technical Feasibility, and Clinical Effect. Neurourol Urodyn. 2026 Jun 17. doi: 10.1002/nau.70327. Online ahead of print.

    PubMed 42311071

Questions about this trial

What is this clinical trial studying?

A study testing Amber UI System in people with Overactive Bladder and Urge 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 12 inclusion and 30 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 12 Aug 2024. 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?

Adverse Device Events (time frame: 24 hours; 1 week; 4 weeks; 3 months; 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05241379, which also lists 1 linked publication.

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 12 Aug 2024.

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AURA-2: Augmenting Urinary Reflex Activity | AzTrials