Clinical trial NCT05256498: AURA 1: Augmenting Urinary Reflex Activity: Study 1
Official title: Electrophysiological Studies of the Human Pudendal Nerve Using Short-duration Extracorporeal Stimulation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Overactive Bladder
Urge Incontinence
Lead sponsor: Amber Therapeutics Ltd
Sponsor class: INDUSTRY
First posted: 2022-02-25
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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


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

Primary outcomes:
measure: Intraoperative pelvic floor electromyography (EMG)
timeFrame: 24 Hours
Secondary outcomes:
measure: Pelvic floor electromyography (EMG)
timeFrame: 24 Hours
measure: Technical outcomes
timeFrame: 24 Hours
Other outcomes:
Locations:
Study officials:
References: