Clinical trial NCT06885931: Augmenting Urinary Reflex Activity Study 4 (including EXtended Indications)
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mixed Urinary Incontinence
Stress Urinary Incontinence (SUI)
Chronic Pelvic Pain
Lead sponsor: Amber Therapeutics Ltd
Sponsor class: INDUSTRY
First posted: 2025-03-20
Enrollment: 56
Sex: FEMALE
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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 where these cannot be restricted for a period of 6 weeks post-implantation.
* Patient unwilling to stop any future participation in scuba diving below 10m. BMI ≥ 40kg/m2 or waist circumference \> 106cm
* Documented history of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone.
* Skin, orthopedic or neurological anatomical limitations at the site of implant that could prevent successful placement of an electrode or IPG. This includes active perineal sepsis or perianal sepsis (e.g., anal fistula and pilonidal sinus).
* Knowledge of planned MRIs, diathermy, microwave exposure, high output ultrasonic exposure, or RF energy exposure.
* Implantable neurostimulator or antennae, pacemaker or defibrillator in-situ (anywhere in body).

Primary outcomes:
measure: Summative rates of procedural and device related adverse events and device deficiencies.
timeFrame: 12 months
measure: Urinary Distress Inventory score change
timeFrame: 6 months
measure: Proportion of participants requiring surgical reintervention.
timeFrame: 12 months
Secondary outcomes:
measure: Urinary Distress Inventory (total, total Mixed Urinary Incontinence) score change
timeFrame: 12 months
measure: 3-day voiding diary number of events
timeFrame: 12 months
measure: 24-hour pad test weight change
timeFrame: 12 months
measure: The International Consultation on Incontinence Questionnaire score change
timeFrame: 12 months
measure: Patient Global Impression of Improvement score change
timeFrame: 12 months
measure: General Anxiety Disorder score change
timeFrame: 12 months
measure: Patient Health Questionnaire 9 score change
timeFrame: 12 months
measure: World Health Organization Disability Assessment Schedule score change
timeFrame: 12 months
measure: European Quality of Life 5 Dimension Questionnaire score change.
timeFrame: 12 months
Other outcomes:
measure: Numeric pain rating scale (NPRS) score change (Cohort B Chronic Pelvic Pain only)
timeFrame: 12 months
Locations:
Study officials:
References: