Augmenting Urinary Reflex Activity Study 4 (Including eXtended Indications)

NCT06885931 | Recruiting DMC

• 1 other identifier: TS-01529
• Study Type: interventional
• Target: 56
• Locations: 3 countries
• Sites: 5

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.

Conditions

Stress Urinary Incontinence (SUI); Chronic Pelvic Pain; Mixed Urinary Incontinence

Outcome Measures

Primary Outcomes (3)

• Summative rates of procedural and device related adverse events and device deficiencies.

  12 months

• Urinary Distress Inventory score change

  Score minimum 0 to maximum 100. Lower score is better outcome.

  6 months

• Proportion of participants requiring surgical reintervention.

  12 months

Secondary Outcomes (9)

• Urinary Distress Inventory (total, total Mixed Urinary Incontinence) score change

  12 months

• 3-day voiding diary number of events

  12 months

• 24-hour pad test weight change

  12 months

• The International Consultation on Incontinence Questionnaire score change

  12 months

• Patient Global Impression of Improvement score change

  12 months

Other Outcomes (1)

• Numeric pain rating scale (NPRS) score change (Cohort B Chronic Pelvic Pain only)

  12 months

Study Arms (2)

Cohort A

EXPERIMENTAL

Mixed Urinary Incontinence cohort

Device: Pudendal neuromodulation

Cohort B

EXPERIMENTAL

Extended indications cohort (Stress Urinary Incontinence, Chronic Pelvic Pain, AURA-2)

Device: Pudendal neuromodulation

Interventions

Pudendal neuromodulation DEVICE

In this feasibility study, all subjects will receive the Amber UI system.

Cohort A; Cohort B

Eligibility Criteria

• Age: 22 Years+
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Amber Therapeutics Ltd: lead

Study Sites (5)

UZ Leuven

Leuven, Herestraat 49, 3000, Belgium

NOT YET RECRUITING

Universitair Ziekenhuis Antwerpen

Edegem, 655, 2650, Belgium

RECRUITING

Ghent University Hospital

Ghent, 9000, Belgium

RECRUITING

Maastricht UMC

Maastricht, 6229 HX, Netherlands

NOT YET RECRUITING

University College London Hospital

London, NW1 2BU, United Kingdom

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Amber Clinical Affairs

CONTACT

08000418515; AURA-4X@amber-tx.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: March 20, 2025
• Study Start: June 24, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): August 1, 2029
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (3); NL (1); GB (1)