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

Amber Therapeutics Ltd0 sitesApril 2022

ConditionsOveractive Bladder Urge Incontinence

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Overactive Bladder
Sponsor: Amber Therapeutics Ltd
Primary Endpoint: Intraoperative pelvic floor electromyography (EMG)
Status: Withdrawn
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

April 2022

End Date

December 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Amber Therapeutics Ltd

Responsible Party

Sponsor

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.