AURA1: AURA 1: Augmenting Urinary Reflex Activity: Study 1
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Amber UI Stimulation Short-duration pudendal nerve stimulation |
Device: Picostim Amber
Picostim Amber temporary (24h) lead placement and extracorporeal stimulation
|
Outcome Measures
Primary Outcome Measures
- Intraoperative pelvic floor electromyography (EMG) [24 Hours]
Intra-operative measurements of amplitude of pelvic floor EMG upon pudendal nerve stimulation
Secondary Outcome Measures
- Pelvic floor electromyography (EMG) [24 Hours]
Amplitude pelvic floor EMG upon pudendal nerve stimulation
- Technical outcomes [24 Hours]
Number of successfully implanted leads
Eligibility Criteria
Criteria
Inclusion Criteria:
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Female patients aged ≥ 18 years with urological indications (OAB, UUI, UFS, retention syndromes and pain)
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Meeting criteria for routine SNM (primary or revision surgery) at the discretion of their normal care urologist.
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Ability and willingness to give informed consent
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Willingness to stay overnight in hospital after SNM procedure (as per routine care)
Exclusion Criteria:
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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]
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Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound evaluation of study endpoints
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Any psychiatric or personality disorder at the discretion of the study physician
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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)
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Patient has uncontrolled type I or type II diabetes as defined by their routine care clinician or diabetes with peripheral nerve involvement
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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
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Patient has proven major autoimmune disease, e.g. scleroderma or immunodeficiency (including use of biologic immunomodulatory drugs at time of procedure)
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Patient is not suitable for the study as determined by their routine care physician for any other reason
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Patient is enrolled in another interventional study excepting observational studies, e.g. SNM registries or in relation to disease (see below)
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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
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Patient is significantly obese (defined as BMI ≥ 35) so as to limit electrode lead placement using standard approaches
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Skin, orthopaedic or neurological anatomical limitations that could prevent successful placement of the electrode lead
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Subject with a documented history of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Amber Therapeutics Ltd
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Amber AURA1