Overactive Bladder, Urge Incontinence
Conditions
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
Interventions
DEVICEPicostim Amber
Picostim Amber temporary (24h) lead placement and extracorporeal stimulation
Sponsors
Amber Therapeutics Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative pelvic floor electromyography (EMG) | 24 Hours | Intra-operative measurements of amplitude of pelvic floor EMG upon pudendal nerve stimulation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pelvic floor electromyography (EMG) | 24 Hours | Amplitude pelvic floor EMG upon pudendal nerve stimulation |
| Technical outcomes | 24 Hours | Number of successfully implanted leads |
Outcome results
None listed