Exploratory safety and feasibility study of personalized adaptive pudendal neuromodulation for mixed urinary incontinence and extended indications using an implanted (Picostim™ II) system.
Female. NB: the definition of female refers to sex at birth.
Adult: aged ≥ 22 years (at the time of informed consent signature).
Patient self-reports both stress and urge episodes (clinician-opinion on history taking).
Patient has failed to respond to or could not tolerate conservative treatment as determined by the treating health care provider.
Patient is pregnant, breastfeeding, or plans to become pregnant at any time in the future.
Patient is unwilling or unable to use contraception during sexual intercourse for the duration of the study.
In the event that patient becomes pregnant during or after the study, they are not prepared to inactivate device for the whole period of the pregnancy.
Any significant medical condition that, in the opinion of the Investigator, is likely to interfere with study procedures, device operation, or likely to confound evaluation of study endpoints.
Parallel
Pudendal neuromodulation
DeviceIn this feasibility study, all subjects will receive the Amber UI system.
Summative rates of procedural and device related adverse events and device deficiencies.
Urinary Distress Inventory score change
Score minimum 0 to maximum 100. Lower score is better outcome.
Proportion of participants requiring surgical reintervention.
Urinary Distress Inventory (total, total Mixed Urinary Incontinence) score change
Score minimum 0 to maximum 100. Lower score is better outcome.
3-day voiding diary number of events
Fewer events is better outcome.
24-hour pad test weight change
Lower weight is better outcome.
The International Consultation on Incontinence Questionnaire score change
Score minimum 0 to maximum 21. Lower score is better outcome.
Numeric pain rating scale (NPRS) score change (Cohort B Chronic Pelvic Pain only)
Score minimum 0 to maximum 40. Lower score is better outcome.
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