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

Electrophysiological Studies of the Human Pudendal Nerve Using Short-duration Extracorporeal Stimulation

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

Study Overview

• Status: Not yet recruiting
• Conditions: Overactive Bladder; Urge Incontinence
• Intervention / Treatment: Device: Picostim Amber

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Amber UI Stimulation; Short-duration pudendal nerve stimulation	Device: Picostim Amber; Picostim Amber temporary (24h) lead placement and extracorporeal stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative pelvic floor electromyography (EMG)	Intra-operative measurements of amplitude of pelvic floor EMG upon pudendal nerve stimulation	24 Hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pelvic floor electromyography (EMG)	Amplitude pelvic floor EMG upon pudendal nerve stimulation	24 Hours
Technical outcomes	Number of successfully implanted leads	24 Hours

Collaborators and Investigators

• Sponsor: Amber Therapeutics Ltd

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2022
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: January 24, 2022
• First Submitted That Met QC Criteria: February 16, 2022
• First Posted (Actual): February 25, 2022

Study Record Updates

• Last Update Posted (Actual): February 25, 2022
• Last Update Submitted That Met QC Criteria: February 16, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Urinary Incontinence; Urinary Bladder, Overactive; Urinary Incontinence, Urge
• Other Study ID Numbers: Amber AURA1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No