AURA 1: Augmenting Urinary Reflex Activity: Study 1

NCT ID: NCT05256498

Last Updated: 2023-02-02

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-30
• Study Completion Date: 2022-12-31

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

Conditions

Overactive Bladder; Urge Incontinence

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Amber UI Stimulation

Short-duration pudendal nerve stimulation

Group Type: EXPERIMENTAL

Picostim Amber

Intervention Type: DEVICE

Picostim Amber temporary (24h) lead placement and extracorporeal stimulation

Interventions

Picostim Amber

Picostim Amber temporary (24h) lead placement and extracorporeal stimulation

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Amber Therapeutics Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

Amber AURA1

Identifier Type: -

Identifier Source: org_study_id