Augmenting Urinary Reflex Activity Study 4 (Including eXtended Indications)
Belgium, Netherlands, United Kingdom86 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 range
22 Years
Sex
FEMALE
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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.