Augmenting Urinary Reflex Activity Study 4 (Including eXtended Indications)

NCT ID: NCT06885931

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-24
• Study Completion Date: 2029-08-31

Brief Summary

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort A

Mixed Urinary Incontinence cohort

Group Type: EXPERIMENTAL

Pudendal neuromodulation

Intervention Type: DEVICE

In this feasibility study, all subjects will receive the Amber UI system.

Cohort B

Extended indications cohort (Stress Urinary Incontinence, Chronic Pelvic Pain, AURA-2)

Group Type: EXPERIMENTAL

Pudendal neuromodulation

Intervention Type: DEVICE

In this feasibility study, all subjects will receive the Amber UI system.

Interventions

Pudendal neuromodulation

In this feasibility study, all subjects will receive the Amber UI system.

Intervention Type: DEVICE

Eligibility 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 > 106cm
• 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, microwave exposure, high output ultrasonic exposure, or RF energy exposure.
• Implantable neurostimulator or antennae, pacemaker or defibrillator in-situ (anywhere in body).

• Minimum Eligible Age: 22 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Amber Therapeutics Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Universitair Ziekenhuis Antwerpen

Edegem, , Belgium

Site Status: RECRUITING

Ghent University Hospital

Ghent, , Belgium

Site Status: RECRUITING

Maastricht UMC

Maastricht, , Netherlands

Site Status: NOT_YET_RECRUITING

University College London Hospital

London, , United Kingdom

Site Status: NOT_YET_RECRUITING

Countries

Belgium; Netherlands; United Kingdom

Central Contacts

Amber Clinical Affairs

Role: CONTACT

AURA-4X@amber-tx.com

08000418515

Facility Contacts

Tim Brits, Doctor of Medicine

Role: primary

urologie@uza.be

+32 3 821 30 00

Francois Herve, Professor/ Doctor of Medicine

Role: primary

Francois.Herve@uzgent.be

+3293320839

Martijn Smits, Doctor of Medicine

Role: primary

mac.smits@mumc.nl

+31 (0)6 29 65 22 47

Mahreen Pakzad, Doctor of Medicine

Role: primary

Mahreen.pakzad@nhs.net

Other Identifiers

TS-01529

Identifier Type: -

Identifier Source: org_study_id