AURA-2: Augmenting Urinary Reflex Activity

NCT05241379 | Completed

• 1 other identifier: Amber AURA-2
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

AMBER AURA-2 study (Augmenting Urinary Reflex Activity 2) is a short-duration (6 month) safety and electrophysiological study using an implanted Amber UI system and two electrode leads to provide closed-loop pudendal nerve stimulation for the treatment of urinary incontinence.

Conditions

Overactive Bladder; Urge Incontinence

Outcome Measures

Primary Outcomes (1)

• Adverse Device Events

  Incidence of adverse events as defined by REGULATION (EU) 2017/745(MDR) and MDCG 2020-10/1

  24 hours; 1 week; 4 weeks; 3 months; 6 months

Secondary Outcomes (7)

• Changes in Voiding diary data

  Baseline, 28 days, 3 months, 6 months

• Changes in ICIQ -UI Short Form

  Baseline, 28 days, 3 months, 6 months

• Changes in ICIQ-OAB Quality of Life

  Baseline, 28 days, 3 months, 6 months

• Changes in PGI-I

  Baseline, 28 days, 3 months, 6 months

• Changes in FSFI

  Baseline, 28 days, 3 months, 6 months

Study Arms (1)

Amber UI Therapy

EXPERIMENTAL

Participants will undergo surgical implantation of the Amber UI System incorporating 2 electrode leads connected to a single IPG

Device: Amber UI System

Interventions

Amber UI System DEVICE

The implantable components of the Amber UI system consist of an implantable pulse generator (Picostim Amber IPG), 2 electrode leads with anchoring system

Amber UI Therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients aged ≥ 18 years
• Diagnosis of urinary incontinence, with on a 5-day voiding diary at least 1 daily urgency episode and/or greater than or equal to 8 voids/day and/or by having a minimum of two involuntary leaking episodes in 72 hr
• Duration of urinary incontinence symptom ≥ 6 months prior to the screening baseline visit date
• Failed or is not a candidate for more conservative treatment e.g. pelvic floor muscle therapy or biofeedback or behavioral modification
• Failed or could not tolerate at least one (1) antimuscarinic or beta3-adrenoceptor agonist medication
• Urodynamic testing (uroflowmetry, cystometry and pressure flow) completed within 12 months prior to screening baseline visit date or is willing to have testing at screening baseline visit
• Cystoscopy test completed within 12 months prior to the screening baseline visit date or is willing to have a test at screening baseline visit
• Is willing and able to washout from OAB medications for at least 4 week prior to beginning the baseline voiding diary
• Ability and willingness to give informed consent including language constraints (see above)
• Able to participate in all testing and follow-up clinic visits associated with study protocol
• Capable of independently using the system components (after training) as described in the Patient Manual
• Mobile and able to use toilet without assistance

You may not qualify if:

• General:
• Patient is pregnant, breastfeeding, or plans to become pregnant during the course of the study (pregnancy tests provided in schedule)
• Patient is unwilling or unable to use contraception during sexual intercourse for the duration of the study, and thereafter if implant remains in the longer term.
• Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound evaluation of study endpoints
• Any psychiatric or personality disorder at the discretion of the study physician
• Any neurological condition that may interfere with normal bladder function (e.g., stroke, multiple sclerosis, Parkinson's disease; clinically significant peripheral neuropathy, or complete spinal cord injury)
• Patient has uncontrolled type I or type II diabetes as defined by their routine care clinician or diabetes with peripheral nerve involvement
• Any history of any pelvic cancer
• Patient has history of other non-pelvic neoplasia within 5 years prior to enrolment, except for a cancer that was determined to be local occurrence only, such as basal cell carcinoma, or is receiving or planning to receive anti-cancer or anti-angiogenic drugs
• Patient has proven major autoimmune disease, e.g. scleroderma or immunodeficiency (including use of biologic immunomodulatory drugs at time of procedure)
• Life expectancy of less than 1 year
• Patient is a frail elderly and/or with notable clinical evidence of sarcopaenia
• Patient is not suitable for the study as determined by their routine care physician for any other reason
• Patient is enrolled in another interventional study excepting observational studies, e.g. SNM registries or in relation to disease (see below)
• Patient participation in vigorous sporting activities where these cannot be restricted for a period of 6 weeks post-implantation.

Sponsors & Collaborators

• Amber Therapeutics Ltd: lead

Study Sites (1)

University Hospital Antwerp

Antwerp, 2650, Belgium

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence, Urge

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; 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; Urinary Incontinence; Urination Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: February 15, 2022
• Study Start: November 30, 2022
• Primary Completion: April 15, 2024
• Study Completion: April 15, 2024
• Last Updated: August 12, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)