Augmenting Urinary Reflex Activity Study 4 (including EXtended Indications)

Launched by AMBER THERAPEUTICS LTD · Mar 13, 2025

Keywords

ClinConnect Summary

The Augmenting Urinary Reflex Activity Study 4 is looking at a new treatment option for women with mixed urinary incontinence, stress urinary incontinence, and chronic pelvic pain. This study is exploring the safety and feasibility of a personalized device called the Picostim™ II, which aims to help improve bladder control by stimulating nerves involved in urinary function. The study is not yet recruiting participants but is seeking women aged 22 and older who have experienced urinary incontinence symptoms for at least six months and have not found relief from other treatments.

To be eligible for the study, participants must be women who are able to sign consent and participate in all study activities. They should have both stress and urge incontinence episodes and should be mobile enough to use a toilet independently. Important to note, women who are pregnant, breastfeeding, or have certain medical conditions or ongoing treatments may not be able to participate. If chosen for the study, participants can expect to undergo training on how to use the device and will attend follow-up visits to monitor their progress and any potential side effects. This study aims to provide valuable insights into a new approach for managing urinary issues in women.

Gender

FEMALE

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).