AURA 1: Augmenting Urinary Reflex Activity: Study 1 (AURA1)

Amber Therapeutics

Status

Withdrawn

Conditions

Urge Incontinence

Overactive Bladder

Treatments

Device: Picostim Amber

Study type

Interventional

Funder types

Industry

Identifiers

NCT05256498

Amber AURA1

Details and patient eligibility

About

AURA 1 (Augmenting Urinary Reflex Activity: study 1) is a study that evaluates the electrophysiological responses of pudendal nerve stimulation using short-duration extracorporeal stimulation

Sex

Female

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Female patients aged ≥ 18 years with urological indications (OAB, UUI, UFS, retention syndromes and pain)
Meeting criteria for routine SNM (primary or revision surgery) at the discretion of their normal care urologist.
Ability and willingness to give informed consent
Willingness to stay overnight in hospital after SNM procedure (as per routine care)

Exclusion criteria

Patient is pregnant, breastfeeding, or plans to become pregnant during the course of the study (pregnancy tests provided in schedule) [this is an exclusion for SNM in any case]
Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound evaluation of study endpoints
Any psychiatric or personality disorder at the discretion of the study physician
Any neurological condition that may interfere with normal bladder function (e.g., stroke, multiple sclerosis, Parkinson's disease; clinically significant peripheral neuropathy, or complete spinal cord injury)
Patient has uncontrolled type I or type II diabetes as defined by their routine care clinician or diabetes with peripheral nerve involvement
Patient has history of other non-pelvic neoplasia within 5 years prior to enrolment, except for a cancer that was determined to be local occurrence only, such as basal cell carcinoma, or is receiving or planning to receive anti-cancer or anti-angiogenic drugs
Patient has proven major autoimmune disease, e.g. scleroderma or immunodeficiency (including use of biologic immunomodulatory drugs at time of procedure)
Patient is not suitable for the study as determined by their routine care physician for any other reason
Patient is enrolled in another interventional study excepting observational studies, e.g. SNM registries or in relation to disease (see below)
Patient participation in vigorous sporting activities where these cannot be restricted for a period of 24h while the extracorporeal lead is in situ.

Specific urological

• As per routine clinical SNM criteria (see: https://www.nice.org.uk/guidance/ipg6434)

Specific technical

Patient is significantly obese (defined as BMI ≥ 35) so as to limit electrode lead placement using standard approaches
Skin, orthopaedic or neurological anatomical limitations that could prevent successful placement of the electrode lead
Subject with a documented history of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone