Augmenting Urinary Reflex Activity Study 4 (Including eXtended Indications)
Belgium, Netherlands, United Kingdom56 participantsStarted 2025-06-24
Plain-language summary
Exploratory safety and feasibility study of personalized adaptive pudendal neuromodulation for mixed urinary incontinence and extended indications using an implanted (Picostim™ II) system.
Who can participate
Age range22 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
* Duration of urinary incontinence symptom ≥ 6 months prior to the screening baseline visit date.
* Able and willing to voluntarily sign informed consent form.
* Able to participate in all testing and follow-up clinic visits associated with study protocol.
* Patient is mobile and able to use a toilet.
* In the opinion of the Investigator, the patient is capable of independently using the system components (after training).
Exclusion Criteria:
* 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.
* History of major psychiatric or personality disorder.
* Any neurological condition that in the opinion of the investig…
What they're measuring
1
Summative rates of procedural and device related adverse events and device deficiencies.
Timeframe: 12 months
2
Urinary Distress Inventory score change
Timeframe: 6 months
3
Proportion of participants requiring surgical reintervention.