Mixed Urinary IncontinenceAURA-4XNCT06885931
Augmenting Urinary Reflex Activity Study 4 (Including eXtended Indications)
A study testing Pudendal neuromodulation in people with Mixed Urinary Incontinence and Stress Urinary Incontinence (SUI), run by Amber Therapeutics Ltd at 7 sites in 3 countries.
Trial summary
Exploratory safety and feasibility study of personalized adaptive pudendal neuromodulation for mixed urinary incontinence and extended indications using an implanted (Picostim™ II) system. Read more about this study
- Who is it for?
- Ages 22 years and older, women only
- Conditions the study is for
- Mixed Urinary Incontinence, Stress Urinary Incontinence (SUI), Chronic Pelvic Pain
- What is being tested?
- Pudendal neuromodulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 24 Jun 2025to Jan 2030
- Phase
- Interventional
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 22 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female. NB: the definition of female refers to sex at birth.
- Adult: aged ≥ 22 years (at the time of informed consent signature).
- Patient self-reports both stress and urge episodes (clinician-opinion on history taking).
- Patient has failed to respond to or could not tolerate conservative treatment as determined by the treating health care provider.
- Duration of urinary incontinence symptom ≥ 6 months prior to the screening baseline visit date.
- Able and willing to voluntarily sign informed consent form.
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- Able to participate in all testing and follow-up clinic visits associated with study protocol.
- Patient is mobile and able to use a toilet.
- In the opinion of the Investigator, the patient is capable of independently using the system components (after training).
Who cannot join
- Patient is pregnant, breastfeeding, or plans to become pregnant at any time in the future.
- Patient is unwilling or unable to use contraception during sexual intercourse for the duration of the study.
- In the event that patient becomes pregnant during or after the study, they are not prepared to inactivate device for the whole period of the pregnancy.
- Any significant medical condition that, in the opinion of the Investigator, is likely to interfere with study procedures, device operation, or likely to confound evaluation of study endpoints.
- History of major psychiatric or personality disorder.
- Any neurological condition that in the opinion of the investigator 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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- Uncontrolled type I or type II diabetes (as defined by their routine care clinician or HBA1C ≥ 7.0).
- History of cancer within 5 years prior to enrolment, except for a cancer that was determined to be free of systemic cancer risk, such as basal cell carcinoma.
- Patient is taking antiplatelet and/or anticoagulant drugs including warfarin or newer alternatives (e.g., rivaroxaban, apixaban, dabigatran, edoxaban) which cannot be paused prior to surgery, or has a bleeding disorder that cannot be corrected prior to surgery.
- Any clinical reason that, in the opinion of the Investigator, may compromise patient's safety during the study.
- Currently participating in another interventional study. This excepts purely observational studies, e.g., registries.
- Patient participation in vigorous physical activities where these cannot be restricted for a period of 6 weeks post-implantation.
- Patient unwilling to stop any future participation in scuba diving below 10m. BMI ≥ 40kg/m2 or waist circumference > 127cm
- Documented history of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone.
- Skin, orthopedic or neurological anatomical limitations at the site of implant that could prevent successful placement of an electrode or IPG. This includes active perineal sepsis or perianal sepsis (e.g., anal fistula and pilonidal sinus).
- Knowledge of planned MRIs, diathermy, medical microwave exposure, high output ultrasonic exposure, or medical RF energy exposure.
- Implantable neurostimulator or antennae, pacemaker or defibrillator in-situ (anywhere in body).
- Known diagnosis of interstitial cystitis or bladder pain syndrome as defined by either AUA or EAU guidelines. Diagnosis of any other chronic pelvic or regional pain syndrome
- Documented bladder emptying syndrome including neurogenic bladder.
- Known abnormal post void residual (> 100 ml).
- Any prolapse (symptomatic or asymptomatic) currently at or below the hymenal level Known urinary tract mechanical obstruction such as urethral stricture and/or bladder neck contracture.
- Current symptomatic urinary tract infection (UTI) or more than 3 culture-proven UTIs in past year.
- Current diagnosis of vesicoureteral reflux
- Current diagnosis of bladder stones
- History of bladder tumour (benign or malignant) -Suspected or proven pudendal nerve entrapment syndrome. In patients with co- existent chronic pelvic pain and urinary incontinence symptoms, Nantes criteria will be used for screening. Patients meeting essential criteria will be excluded from the study.
- Suspected or proven severe pudendal nerve damage at discretion of clinician with or without specialist investigations
- Any previous experience of pudendal nerve stimulation using an implanted lead.
- Previous failure of SNM therapy (based on implantation; failed test phase is not an exclusion)
- Major previous urethral or bladder surgery (excisional or reconstructive) at discretion of investigator
- SUI surgery e.g. urethral slings, tapes, and bulking agents colposuspension within last 2 years; > 2 years at discretion of investigator
- Prolapse surgery e.g. colposuspension / colporrhaphy within last 12 months with current confirmation via pelvic exam of no recurrence > or = to Stage 2 pelvic organ prolapse
- Previous use of bladder botox injections within last 6 months
Trial locations and contacts
7 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 3 countries
Belgium3 sites, 3 recruiting
- Recruiting
Universitair Ziekenhuis Antwerpen
Edegem, 655, 2650
Tim Brits, Doctor of Medicine, +32 3 821 30 00, urologie@uza.be
- Recruiting
Ghent University Hospital
Ghent, 9000
Francois Herve, Professor/ Doctor of Medicine, +3293320839, Francois.Herve@uzgent.be
- Recruiting
UZ Leuven
Leuven, Herestraat 49, 3000
Frank Van der Aa, Professor/ Doctor of Medicine, +32 16 34 83 45, frank.vanderaa@uzleuven.be
United Kingdom3 sites, 3 recruiting
- Recruiting
Southmead Hospital
Bristol
Victoria Garner, 01174148109, victoria.garner@nbt.nhs.uk
- Recruiting
University College London Hospital
London, NW1 2BU
Mahreen Pakzad, Doctor of Medicine, Mahreen.pakzad@nhs.net
- Not yet recruiting
Guy's Hospital
London
Arun Sahai, 07956394943, Arun.sahai@nhs.net
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht UMC
Maastricht, 6229 HX
Martijn Smits, Doctor of Medicine, +31 (0)6 29 65 22 47, mac.smits@mumc.nl
About this study
Official title: Exploratory Safety and Feasibility Study of Personalized Adaptive Pudendal Neuromodulation for Mixed Urinary Incontinence and Extended Indications Using an Implanted (Picostim IITM) System
Exploratory safety and feasibility study of personalized adaptive pudendal neuromodulation for mixed urinary incontinence and extended indications using an implanted (Picostim™ II) system.
- Conditions
- Mixed Urinary Incontinence, Stress Urinary Incontinence (SUI), Chronic Pelvic Pain, Urge Urinary Incontinence
- Being tested
- Pudendal neuromodulation
- Medical subject headings
- Urinary Incontinence, Stress, Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pudendal neuromodulationDevice
In this feasibility study, all subjects will receive the Amber UI system.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | Mixed Urinary Incontinence cohort Receives: Device: Pudendal neuromodulation |
| Cohort B | Experimental | Extended indications cohort (Stress Urinary Incontinence, Urge Urinary Incontinence, Chronic Pelvic Pain, AURA-2) Receives: Device: Pudendal neuromodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Summative rates of procedural and device related adverse events and device deficiencies.
Measured: 12 months
Urinary Distress Inventory score change
Score minimum 0 to maximum 100. Lower score is better outcome.
Measured: 6 months
Proportion of participants requiring surgical reintervention.
Measured: 12 months
Secondary outcomes (9)
Urinary Distress Inventory (total, total Mixed Urinary Incontinence) score change
Score minimum 0 to maximum 100. Lower score is better outcome.
Measured: 12 months
3-day voiding diary number of events
Fewer events is better outcome.
Measured: 12 months
24-hour pad test weight change
Lower weight is better outcome.
Measured: 12 months
The International Consultation on Incontinence Questionnaire score change
Score minimum 0 to maximum 21. Lower score is better outcome.
Measured: 12 months
Patient Global Impression of Improvement score change
Score minimum 0 to maximum 7. Lower score is better outcome.
Measured: 12 months
General Anxiety Disorder score change
Score minimum 0 to maximum 21. Lower score is better outcome.
Measured: 12 months
Patient Health Questionnaire 9 score change
Score minimum 0 to maximum 27. Lower score is better outcome.
Measured: 12 months
World Health Organization Disability Assessment Schedule score change
Score minimum 0 to maximum 100. Lower score is better outcome.
Measured: 12 months
European Quality of Life 5 Dimension Questionnaire score change.
Score minimum 5 to maximum 25. Higher score is a better outcome.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start24 Jun 2025
- Primary completionJun 2027 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mixed 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amber Therapeutics Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06885931
- Sponsor's protocol ID
- TS-01529
- Acronym
- AURA-4X
- Status last verified
- Mar 2026
- First submitted
- 6 Mar 2025
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No