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Augmenting Urinary Reflex Activity Study 4 (Including eXtended Indications)

Sponsor: Amber Therapeutics Ltd

NCT ID: NCT06885931

View on ClinicalTrials.gov ↗

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.

Mixed Urinary IncontinenceStress Urinary Incontinence (SUI)Chronic Pelvic PainUrge Urinary Incontinence

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

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
Inclusion Criteria: * 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. * 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). Exclusion Criteria: * 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). * 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). Exclusion Criteria (Urological): * 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

Where Is This Study? (3 UK sites)

Southmead Hospital

Bristol, United Kingdom

Recruiting
Site contact (verified)

University College London Hospital

London NW1 2BU, United Kingdom

Recruiting
Site contact (verified)
Mahreen Pakzad, Doctor of MedicineMahreen.pakzad@nhs.net

Guy's Hospital

London, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)

How to Get in Touch

Amber Clinical Affairs

Sponsor contact

CONTACT

08000418515 AURA-4X@amber-tx.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-03