Augmenting Urinary Reflex Activity Study 4 (Including eXtended Indications) (AURA-4X)

Amber Therapeutics

Status: Enrolling

Conditions: Stress Urinary Incontinence (SUI); Chronic Pelvic Pain; Mixed Urinary Incontinence

Treatments: Device: Pudendal neuromodulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT06885931

TS-01529

Details and patient eligibility

About

Exploratory safety and feasibility study of personalized adaptive pudendal neuromodulation for mixed urinary incontinence and extended indications using an implanted (Picostim™ II) system.

Enrollment: 56 estimated patients

Sex: Female

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

56 participants in 2 patient groups

Cohort A

Experimental group

Description:

Mixed Urinary Incontinence cohort

Treatment:

Device: Pudendal neuromodulation

Cohort B

Experimental group

Description:

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

Treatment:

Device: Pudendal neuromodulation