Augmenting Urinary Reflex Activity Study 4 (Including eXtended Indications) (AURA-4X)

May 13, 2026 updated by: Amber Therapeutics Ltd

Exploratory Safety and Feasibility Study of Personalized Adaptive Pudendal Neuromodulation for Mixed Urinary Incontinence and Extended Indications Using an Implanted (Picostim IITM) System

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
86

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Belgium
      • Edegem, Belgium, 655, 2650
        • Recruiting
        • Universitair Ziekenhuis Antwerpen
        • Contact:
          • Tim Brits, Doctor of Medicine
          • Phone Number: +32 3 821 30 00
          • Email: urologie@uza.be
      • Ghent, Belgium, 9000
        • Recruiting
        • Ghent University Hospital
        • Contact:
    • Herestraat 49
      • Leuven, Herestraat 49, Belgium, 3000
        • Recruiting
        • UZ Leuven
        • Contact:
  • Netherlands
      • Maastricht, Netherlands, 6229 HX
        • Recruiting
        • Maastricht UMC
        • Contact:
          • Martijn Smits, Doctor of Medicine
          • Phone Number: +31 (0)6 29 65 22 47
          • Email: mac.smits@mumc.nl
  • United Kingdom
      • Bristol, United Kingdom
      • London, United Kingdom, NW1 2BU
        • Recruiting
        • University College London Hospital
        • Contact:
      • London, United Kingdom
        • Not yet recruiting
        • Guy's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cohort A
Mixed Urinary Incontinence cohort
Device: Pudendal neuromodulation
In this feasibility study, all subjects will receive the Amber UI system.
Experimental: Cohort B
Extended indications cohort (Stress Urinary Incontinence, Urge Urinary Incontinence, Chronic Pelvic Pain, AURA-2)
Device: Pudendal neuromodulation
In this feasibility study, all subjects will receive the Amber UI system.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Summative rates of procedural and device related adverse events and device deficiencies.
Time Frame: 12 months
12 months
Urinary Distress Inventory score change
Time Frame: 6 months
Score minimum 0 to maximum 100. Lower score is better outcome.
6 months
Proportion of participants requiring surgical reintervention.
Time Frame: 12 months
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Urinary Distress Inventory (total, total Mixed Urinary Incontinence) score change
Time Frame: 12 months
Score minimum 0 to maximum 100. Lower score is better outcome.
12 months
3-day voiding diary number of events
Time Frame: 12 months
Fewer events is better outcome.
12 months
24-hour pad test weight change
Time Frame: 12 months
Lower weight is better outcome.
12 months
The International Consultation on Incontinence Questionnaire score change
Time Frame: 12 months
Score minimum 0 to maximum 21. Lower score is better outcome.
12 months
Patient Global Impression of Improvement score change
Time Frame: 12 months
Score minimum 0 to maximum 7. Lower score is better outcome.
12 months
General Anxiety Disorder score change
Time Frame: 12 months
Score minimum 0 to maximum 21. Lower score is better outcome.
12 months
Patient Health Questionnaire 9 score change
Time Frame: 12 months
Score minimum 0 to maximum 27. Lower score is better outcome.
12 months
World Health Organization Disability Assessment Schedule score change
Time Frame: 12 months
Score minimum 0 to maximum 100. Lower score is better outcome.
12 months
European Quality of Life 5 Dimension Questionnaire score change.
Time Frame: 12 months
Score minimum 5 to maximum 25. Higher score is a better outcome.
12 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Numeric pain rating scale (NPRS) score change (Cohort B Chronic Pelvic Pain only)
Time Frame: 12 months
Score minimum 0 to maximum 40. Lower score is better outcome.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Amber Therapeutics Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 24, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 6, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 20, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TS-01529

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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