At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Pudendal neuromodulation (device)
- How long the study runs
- Study runs about 55 months (dates as stated)
- About the drug or intervention
- Pudendal neuromodulation — device: In this feasibility study, all subjects will receive the Amber UI system.
- Patient visit burden
- Not specified by the sponsor
In plain English
This study, run by Amber Therapeutics Ltd, is looking at women aged 22 or over who have both stress and urge urinary incontinence (leaking urine) that has lasted at least 6 months and has not improved with standard non-surgical treatment. The study also covers chronic pelvic pain and urge urinary incontinence.
Who can take part
- Women aged 22 or older (sex at birth)
- Leaks urine with both stress (e.g. when coughing or exercising) and urge (a sudden strong need to pass water) episodes, reported by the patient
- Urinary incontinence symptoms for at least 6 months
- Has not responded to or could not tolerate earlier non-surgical treatment
- Able and willing to give informed consent and attend all study visits
- Able to walk and use a toilet
- In the researcher's view, able to use the study device on their own after training
- Willing and able to use contraception during the study and avoid pregnancy, including agreeing to switch off the device if pregnancy happens
Who may not be able to
- Pregnant, breastfeeding, or planning a future pregnancy
- Unwilling or unable to use contraception during the study
- A major medical condition that could interfere with the study, the device, or safety checks
- History of a serious mental health or personality disorder
- Nerve conditions that may affect bladder control (such as stroke, multiple sclerosis, Parkinson's disease, significant nerve damage in the limbs, or complete spinal cord injury)
- Uncontrolled diabetes (type 1 or type 2), including an HbA1c test result of 7.0 or higher
- Cancer in the last 5 years, apart from some low-risk skin cancers such as basal cell carcinoma
- Taking blood-thinning medicines (such as warfarin, rivaroxaban, apixaban, dabigatran or edoxaban) that cannot be safely paused before surgery, or a bleeding disorder that cannot be corrected
- Taking part in another study that tests a treatment (observation-only studies such as registries are allowed)
- Cannot avoid vigorous physical activity for 6 weeks after the implant is fitted
- Not willing to stop scuba diving below 10 metres in future
- Body mass index (BMI) of 40 or more, or waist measurement over 127 cm
- Allergy to titanium, zirconia, polyurethane, epoxy or silicone
- Skin, bone or nerve problems at the implant site that would stop the device being fitted, including infection near the area (such as an anal fistula or pilonidal sinus)
- Planned MRI scans or treatments using diathermy, medical microwaves, high-power ultrasound or medical radiofrequency energy
- Already having an implanted nerve stimulator, pacemaker or defibrillator in the body
- Diagnosis of interstitial cystitis, bladder pain syndrome, or other long-term pelvic or regional pain conditions
- Bladder emptying problems, including neurogenic bladder
- Larger than normal amount of urine left in the bladder after passing water (more than 100 ml)
- Any pelvic organ prolapse at or below the opening of the vagina, whether or not it causes symptoms
- A blockage in the urinary system, such as a narrowed urethra or bladder neck
- A current urinary tract infection (UTI), or more than 3 confirmed UTIs in the past year
- Vesicoureteral reflux (urine flowing backwards towards the kidneys)
- Bladder stones
- Past bladder tumours, whether cancerous or not
- Suspected or confirmed pudendal nerve entrapment or severe pudendal nerve damage
- Previous pudendal nerve stimulation with an implanted lead
- Previous failed sacral nerve stimulation (SNM) therapy after a full implant was fitted (failing the test stage is allowed)
- Major past surgery on the urethra or bladder, at the researcher's discretion
- Surgery for stress incontinence (such as slings, tapes, bulking agents or colposuspension) in the last 2 years, or longer ago at the researcher's discretion
- Prolapse surgery in the last 12 months, or current prolapse of stage 2 or worse confirmed by examination
- Bladder botox injections in the last 6 months
What taking part involves
- • Not stated — ask the trial team
Time commitment: Not stated — ask the trial team; participants must be able to attend all study and follow-up clinic visits and avoid vigorous activity for 6 weeks after implantation.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 22 Years and over
- Who
- Female
- Number of participants
- 86
- Started
- 2025-06-24
- Last checked
- 2026-03
Plain English Summary
What is this study?
- • Testing a new treatment for mixed urinary incontinence
- • NA - 86 participants
- • Exploratory safety and feasibility study of personalized adaptive pudendal neuromodulation for mixed urinary incontinence and extended indications using an implanted (Picostim™ II) system
Who can take part?
- • Ages 22 Years and over
- • Diagnosed with mixed urinary incontinence
- • Female only
Where?
- • Bristol - Southmead Hospital
- • London - University College London Hospital
- • London - Guy's Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
Exploratory safety and feasibility study of personalized adaptive pudendal neuromodulation for mixed urinary incontinence and extended indications using an implanted (Picostim™ II) system.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 22 Years and over
- Who can join: Female only
What the study is looking for
- ✓Female. NB: the definition of female refers to sex at birth.
- ✓Adult: aged ≥ 22 years (at the time of agreement to take part 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...
- ✓Duration of urinary incontinence symptom ≥ 6 months prior to the screening baseline visit date.
Who cannot take part
- ✗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...
- ✗Any significant medical condition that, in the opinion of the Investigator, is likely to interfere with study...
- ✗History of major psychiatric or personality disorder.
See the full criteria
Where Is This Study? (3 UK sites)
Southmead Hospital
Bristol, United Kingdom
University College London Hospital
London NW1 2BU, United Kingdom
Guy's Hospital
London, United Kingdom
How to Get in Touch
Amber Clinical Affairs
Sponsor contactCONTACT
