Actively Recruiting
Exploratory Safety and Feasibility Study of Personalized Adaptive Pudendal Neuromodulation for Mixed Urinary Incontinence and Extended Indications Using an Implanted Picostim II System
Led by Amber Therapeutics Ltd · Updated on 2026-05-15
86
Participants Needed
7
Research Sites
135 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and feasibility of a personalized adaptive pudendal neuromodulation system called Picostim II for women experiencing mixed urinary incontinence and related conditions. This exploratory study focuses on women aged 22 years and older who have not responded to or tolerated conservative treatments for urinary incontinence symptoms lasting at least six months. The study includes participants with mixed urinary incontinence and those with extended indications such as stress urinary incontinence, urge urinary incontinence, and chronic pelvic pain. All participants will receive the Amber UI system, an implanted device designed to provide pudendal neuromodulation. The study involves two groups: one with mixed urinary incontinence and another with extended indications. The device is implanted and personalized to each participant's needs, with follow-up and monitoring scheduled over 12 months. Researchers will observe procedural and device-related safety, device deficiencies, and the need for any surgical reintervention during this period. Participants will undergo various assessments including changes in urinary distress, frequency of urinary events, pad test weight, quality of life, anxiety, and health questionnaires over the course of 12 months. The primary safety outcomes focus on adverse events related to the procedure and device. Follow-up visits will help track the device's use, participant adherence, and overall health status. The total study duration for each participant includes baseline evaluation and monitoring over a year after implantation.
CONDITIONS
Brief Title
Augmenting Urinary Reflex Activity Study 4 (Including eXtended Indications)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female (sex at birth)
- Aged 22 years or older at the time of consent
- Self-reports both stress and urge urinary incontinence episodes
- Failed or could not tolerate conservative treatments as determined by healthcare provider
- Urinary incontinence symptoms lasting at least 6 months before screening
- Able and willing to sign informed consent
- Able to participate in all testing and follow-up visits
- Mobile and able to use a toilet
- Capable of independently using the device components after training (per Investigator's opinion)
You will not qualify if you...
- Pregnant, breastfeeding, or planning pregnancy
- Unwilling or unable to use contraception during sexual activity for study duration
- Unprepared to inactivate device if pregnancy occurs during or after study
- Significant medical conditions interfering with study or device use (per Investigator's opinion)
- History of major psychiatric or personality disorder
- Neurological conditions affecting bladder function (e.g., stroke, MS, Parkinson's, neuropathy, spinal cord injury)
- Uncontrolled diabetes (HbA1C 65 7.0)
- Cancer history within 5 years except low-risk types
- Taking anticoagulant or antiplatelet drugs that cannot be paused before surgery
- Safety concerns as judged by Investigator
- Currently in another interventional study (except observational)
- Participation in vigorous physical activities that cannot be stopped for 6 weeks post-implant
- Unwilling to stop scuba diving below 10 meters
- BMI 65 40 kg/m2 or waist circumference > 127 cm
- Allergic reactions to titanium, zirconia, polyurethane, epoxy, or silicone
- Skin, orthopedic, or neurological issues at implant site
- Planned exposure to MRI, diathermy, medical microwave, ultrasound, or RF energy
- Existing implanted neurostimulator, pacemaker, or defibrillator
- Diagnosed interstitial cystitis or bladder pain syndrome
- Bladder emptying disorders or neurogenic bladder
- High post-void residual urine (>100 ml)
- Pelvic organ prolapse at or below hymenal level
- Urinary tract obstruction
- Current or frequent urinary tract infections
- Vesicoureteral reflux or bladder stones
- History of bladder tumor
- Pudendal nerve entrapment or severe nerve damage
- Previous pudendal nerve stimulation with implanted lead
- Previous sacral neuromodulation failure
- Major urethral or bladder surgery
- Recent stress urinary incontinence or prolapse surgeries
- Recent bladder botox injections
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants receive the implanted Picostim II system for pudendal neuromodulation to treat urinary incontinence and extended indications.
Multiple visits for device programming and monitoring during the study period
Duration - Up to 12 months
Participants are monitored for safety, device-related events, and treatment effectiveness after device implantation.
Regular follow-up visits over 12 months
Trial Site Locations
Total: 7 locations
1
UZ Leuven
Leuven, Herestraat 49, Belgium, 3000
Actively 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
Actively Recruiting
5
Southmead Hospital
Bristol, United Kingdom
Actively Recruiting
6
University College London Hospital
London, United Kingdom, NW1 2BU
Actively Recruiting
7
Guy's Hospital
London, United Kingdom
Not Yet Recruiting
Research Team
A
Amber Clinical Affairs
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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