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

Overview

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

Interventions

• Device Pudendal neuromodulation
  In this feasibility study, all subjects will receive the Amber UI system.

Primary outcome measures

• Summative rates of procedural and device related adverse events and device deficiencies. [Time frame: 12 months]
• Urinary Distress Inventory score change [Time frame: 6 months]
• Proportion of participants requiring surgical reintervention. [Time frame: 12 months]

Secondary outcome measures (9)

• Urinary Distress Inventory (total, total Mixed Urinary Incontinence) score change [Time frame: 12 months]
• 3-day voiding diary number of events [Time frame: 12 months]
• 24-hour pad test weight change [Time frame: 12 months]
• The International Consultation on Incontinence Questionnaire score change [Time frame: 12 months]
• Patient Global Impression of Improvement score change [Time frame: 12 months]
• General Anxiety Disorder score change [Time frame: 12 months]
• Patient Health Questionnaire 9 score change [Time frame: 12 months]
• World Health Organization Disability Assessment Schedule score change [Time frame: 12 months]
• European Quality of Life 5 Dimension Questionnaire score change. [Time frame: 12 months]

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 > 127cm
• 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, medical microwave exposure, high output ultrasonic exposure, or medical RF energy exposure.
• Implantable neurostimulator or antennae, pacemaker or defibrillator in-situ (anywhere in body).

Exclusion Criteria (Urological):

• Known diagnosis of interstitial cystitis or bladder pain syndrome as defined by either AUA or EAU guidelines. Diagnosis of any other chronic pelvic or regional pain syndrome
• Documented bladder emptying syndrome including neurogenic bladder.
• Known abnormal post void residual (> 100 ml).
• Any prolapse (symptomatic or asymptomatic) currently at or below the hymenal level Known urinary tract mechanical obstruction such as urethral stricture and/or bladder neck contracture.
• Current symptomatic urinary tract infection (UTI) or more than 3 culture-proven UTIs in past year.
• Current diagnosis of vesicoureteral reflux
• Current diagnosis of bladder stones
• History of bladder tumour (benign or malignant) -Suspected or proven pudendal nerve entrapment syndrome. In patients with co- existent chronic pelvic pain and urinary incontinence symptoms, Nantes criteria will be used for screening. Patients meeting essential criteria will be excluded from the study.
• Suspected or proven severe pudendal nerve damage at discretion of clinician with or without specialist investigations
• Any previous experience of pudendal nerve stimulation using an implanted lead.
• Previous failure of SNM therapy (based on implantation; failed test phase is not an exclusion)
• Major previous urethral or bladder surgery (excisional or reconstructive) at discretion of investigator
• SUI surgery e.g. urethral slings, tapes, and bulking agents colposuspension within last 2 years; > 2 years at discretion of investigator
• Prolapse surgery e.g. colposuspension / colporrhaphy within last 12 months with current confirmation via pelvic exam of no recurrence > or = to Stage 2 pelvic organ prolapse
• Previous use of bladder botox injections within last 6 months

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Belgium · 3 centers

• UZ Leuven — Leuven
• Universitair Ziekenhuis Antwerpen — Edegem
• Ghent University Hospital — Ghent

United Kingdom · 3 centers

• Southmead Hospital — Bristol
• University College London Hospital — London
• Guy's Hospital — London

Netherlands · 1 center

• Maastricht UMC — Maastricht

Identifiers

NCT: NCT06885931 · TS-01529

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗