AURA 1: Augmenting Urinary Reflex Activity: Study 1

Not Applicable

Withdrawn

• Conditions: Urge Incontinence; Overactive Bladder
• Interventions: Device: Picostim Amber

• Registration Number: NCT05256498
• Lead Sponsor: Amber Therapeutics Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-24
• Study First Submitted QC: 2022-02-16
• Study First Posted: 2022-02-25
• Study Start: 2022-04
• Primary Completion: 2022-12
• Study Completion: 2022-12
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-31
• Last Update Posted: 2023-02-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Amber UI Stimulation	Picostim Amber	Short-duration pudendal nerve stimulation

Primary Outcome Measures

Name	Time	Method
Intraoperative pelvic floor electromyography (EMG)	24 Hours	Intra-operative measurements of amplitude of pelvic floor EMG upon pudendal nerve stimulation

Secondary Outcome Measures

Name	Time	Method
Pelvic floor electromyography (EMG)	24 Hours	Amplitude pelvic floor EMG upon pudendal nerve stimulation
Technical outcomes	24 Hours	Number of successfully implanted leads