AURA 1: Augmenting Urinary Reflex Activity: Study 1

NCT05256498 | Withdrawn

• 1 other identifier: Amber AURA1
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Intraoperative pelvic floor electromyography (EMG)

  Intra-operative measurements of amplitude of pelvic floor EMG upon pudendal nerve stimulation

  24 Hours

Secondary Outcomes (2)

• Pelvic floor electromyography (EMG)

  24 Hours

• Technical outcomes

  24 Hours

Study Arms (1)

Amber UI Stimulation

EXPERIMENTAL

Short-duration pudendal nerve stimulation

Device: Picostim Amber

Interventions

Picostim Amber DEVICE

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

Amber UI Stimulation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Amber Therapeutics Ltd: lead

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence, Urge

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Incontinence; Urination Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: February 25, 2022
• Study Start: April 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: February 2, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share