Status:
WITHDRAWN
AURA 1: Augmenting Urinary Reflex Activity: Study 1
Lead Sponsor:
Amber Therapeutics Ltd
Conditions:
Overactive Bladder
Urge Incontinence
Eligibility:
FEMALE
18-75 years
Phase:
NA
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
- 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
- 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
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05256498
Start Date
April 1 2022
End Date
December 1 2022
Last Update
February 2 2023
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