Actively Recruiting
Augmenting Urinary Reflex Activity Study 4 (Including eXtended Indications)
Led by Amber Therapeutics Ltd · Updated on 2026-03-19
56
Participants Needed
5
Research Sites
214 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Exploratory safety and feasibility study of personalized adaptive pudendal neuromodulation for mixed urinary incontinence and extended indications using an implanted (Picostim™ II) system.
CONDITIONS
Official Title
Augmenting Urinary Reflex Activity Study 4 (Including eXtended Indications)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female, defined by sex at birth
- Adult aged 22 years or older at consent
- Self-reported stress and urge urinary incontinence episodes
- Failed or could not tolerate conservative treatment as determined by healthcare provider
- Urinary incontinence symptoms present for 6 months or longer before screening
- Able and willing to sign informed consent voluntarily
- Able to participate in all testing and follow-up visits
- Mobile and able to use a toilet
- Capable of independently using system components after training
You will not qualify if you...
- Pregnant, breastfeeding, or planning pregnancy during or after the study
- Unwilling or unable to use contraception during sexual intercourse for study duration
- Not prepared to inactivate device if pregnancy occurs
- Significant medical conditions interfering with study or device use as judged by investigator
- History of major psychiatric or personality disorder
- Neurological conditions affecting bladder function (e.g., stroke, multiple sclerosis, Parkinson's disease, peripheral neuropathy, complete spinal cord injury)
- Uncontrolled diabetes with HbA1c 6 7.0
- History of cancer within 5 years except non-risk basal cell carcinoma
- Use of antiplatelet/anticoagulant drugs that cannot be paused for surgery or bleeding disorders
- Any clinical reason compromising patient safety during study
- Participation in other interventional studies (except observational)
- Participation in vigorous physical activities that cannot be stopped for 6 weeks post-implant
- Unwillingness to stop scuba diving below 10m
- BMI 6 40 kg/m2 or waist circumference > 106 cm
- Allergy to titanium, zirconia, polyurethane, epoxy, or silicone
- Anatomical limitations or active infections at implant site preventing electrode or device placement
- Planned exposure to MRI, diathermy, microwave, high output ultrasound, or RF energy
- Presence of implanted neurostimulator, pacemaker, or defibrillator anywhere in body
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
UZ Leuven
Leuven, Herestraat 49, Belgium, 3000
Not Yet Recruiting
2
Universitair Ziekenhuis Antwerpen
Edegem, Belgium, 655, 2650
Actively Recruiting
3
Ghent University Hospital
Ghent, Belgium, 9000
Actively Recruiting
4
Maastricht UMC
Maastricht, Netherlands, 6229 HX
Not Yet Recruiting
5
University College London Hospital
London, United Kingdom, NW1 2BU
Actively Recruiting
Research Team
A
Amber Clinical Affairs
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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