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Augmenting Urinary Reflex Activity Study 4 (Including eXtended Indications)

RecruitingNot applicableNCT06885931
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

Exploratory safety and feasibility study of personalized adaptive pudendal neuromodulation for mixed urinary incontinence and extended indications using an implanted (Picostim™ II) system.

Study details

Official title
Exploratory Safety and Feasibility Study of Personalized Adaptive Pudendal Neuromodulation for Mixed Urinary Incontinence and Extended Indications Using an Implanted (Picostim IITM) System
Conditions
  • Mixed Urinary Incontinence
  • Stress Urinary Incontinence (SUI)
  • Chronic Pelvic Pain
  • Urge Urinary Incontinence
Interventions
  • Device: Pudendal neuromodulation
Sponsor
Amber Therapeutics Ltd
Start date
2025-06-24
Primary completion
2027-06
Sex
Female
Age range
from 22 Years
Results posted
No results posted in this snapshot
Countries
Belgium, Netherlands, United Kingdom
Total sites listed
7

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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 investigator may interfere with normal bladder function (e.g., stroke, multiple sclerosis, Parkinson's disease, clinically significant peripheral neuropathy, or complete spinal cord injury). * Uncontrolled type I or type II diabetes (as defined by their routine care clinician or HBA1C ≥ 7.0). * History of cancer within 5 years prior to enrolment, except for a cancer that was determined to be free of systemic cancer risk, such as basal cell carcinoma. * Patient is taking antiplatelet and/or anticoagulant drugs including warfarin or newer alternatives (e.g., rivaroxaban, apixaban, dabigatran, edoxaban) which cannot be paused prior to surgery, or has a bleeding disorder that cannot be corrected prior to surgery. * Any clinical reason that, in the opinion of the Investigator, may compromise patient's safety during the study. * Currently participating in another interventional study. This excepts purely observational studies, e.g., registries. * Patient participation in vigorous physical activities wh…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06885931