AURA-2: Augmenting Urinary Reflex Activity (AURA-2)
Primary Purpose
Overactive Bladder, Urge Incontinence
Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Amber UI System
Sponsored by
About this trial
This is an interventional treatment trial for Overactive Bladder
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
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.
Specific urological
- Urinary tract mechanical obstruction such as urethral stricture
- Current symptomatic urinary tract infection (UTI) or more than 3 UTIs in past year
- Pure stress incontinence or mixed incontinence where the stress component overrides the urge component
- Interstitial cystitis or bladder pain syndrome as defined by either AUA or EAU guidelines
- Suspected pudendal nerve entrapment syndrome. In patients with co-existent symptoms of chronic pelvic pain and urinary incontinence, Nantes criteria will be used for screening. Patients meeting essential criteria will be excluded from the study
- Treatment of urinary symptoms with botulinum toxin therapy in the past 12 months
- Prior attempt at pudendal nerve stimulation using an implanted lead
- Treatment of urinary symptoms with tibial or sacral nerve stimulation in the past 3 months (prior experience of either before this time is permitted provided no implants remain in-situ)
Specific technical
- Patient is significantly obese (defined as BMI ≥ 35) so as to limit electrode lead placement using standard approaches
- Skin, orthopaedic or neurological anatomical limitations that could prevent successful placement of the electrode lead
- Knowledge of planned MRIs, diathermy, microwave exposure, high output ultrasonic exposure, or RF energy exposure
- Implantable neurostimulator, pacemaker or defibrillator in situ (anywhere in body including sacral and tibial)
- Subject with a documented history of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone
Sites / Locations
- University Hospital AntwerpRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Amber UI Therapy
Arm Description
Participants will undergo surgical implantation of the Amber UI System incorporating 2 electrode leads connected to a single IPG
Outcomes
Primary Outcome Measures
Adverse Device Events
Incidence of adverse events as defined by REGULATION (EU) 2017/745(MDR) and MDCG 2020-10/1
Secondary Outcome Measures
Changes in Voiding diary data
Changes in 5 days voiding diary data including number of incontinence episodes, number of voids, number of urgency episodes
Changes in ICIQ -UI Short Form
ICIQ-SF-UI questionnaire: is a questionnaire for evaluating frequency, severity and impact on quality of life of urinary incontinence in research and clinical practice. It is a 4 item simple questionnaire
Changes in ICIQ-OAB Quality of Life
ICIQ-OAB Qol questionnaire: is a robust, subject-completed questionnaire for evaluating quality of life (QoL) in subjects with overactive bladder, for use in research and clinical practice. The questionnaire explores in detail the impact on subject's lives of overactive bladder and can be used as an outcome measure to assess impact of different
Changes in PGI-I
Patient Global Impression of Improvement (PGI-I): The PGI-I is a subject-completed transition scale that is a single question asking the subject to rate their urinary tract condition now, as compared with how it was prior to before beginning treatment on a 7 point scale
Changes in FSFI
FSFI - questionnaire: The Female Sexual Function Index (FSFI) is a widely used multidimensional self-reported questionnaire on Female Sexual Dysfunction. It consists of 19 items and assesses 6 domains, including desire, arousal, lubrication, orgasm, satisfaction and pain.
Technical Outcomes
Number of patients successfully implanted
Measurement of EMG
Intra-operative and post-operative (ambulatory) measurements of electromyography
Full Information
NCT ID
NCT05241379
First Posted
January 24, 2022
Last Updated
December 5, 2022
Sponsor
Amber Therapeutics Ltd
1. Study Identification
Unique Protocol Identification Number
NCT05241379
Brief Title
AURA-2: Augmenting Urinary Reflex Activity
Acronym
AURA-2
Official Title
Exploratory Safety and Electrophysiological Study of Closed-loop Pudendal Neuromodulation Using an Implantable (Picostim-DyNeuMo) Device in Women With Urinary Incontinence
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 30, 2022 (Actual)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amber Therapeutics Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder, Urge Incontinence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Amber UI Therapy
Arm Type
Experimental
Arm Description
Participants will undergo surgical implantation of the Amber UI System incorporating 2 electrode leads connected to a single IPG
Intervention Type
Device
Intervention Name(s)
Amber UI System
Intervention Description
The implantable components of the Amber UI system consist of an implantable pulse generator (Picostim Amber IPG), 2 electrode leads with anchoring system
Primary Outcome Measure Information:
Title
Adverse Device Events
Description
Incidence of adverse events as defined by REGULATION (EU) 2017/745(MDR) and MDCG 2020-10/1
Time Frame
24 hours; 1 week; 4 weeks; 3 months; 6 months
Secondary Outcome Measure Information:
Title
Changes in Voiding diary data
Description
Changes in 5 days voiding diary data including number of incontinence episodes, number of voids, number of urgency episodes
Time Frame
Baseline, 28 days, 3 months, 6 months
Title
Changes in ICIQ -UI Short Form
Description
ICIQ-SF-UI questionnaire: is a questionnaire for evaluating frequency, severity and impact on quality of life of urinary incontinence in research and clinical practice. It is a 4 item simple questionnaire
Time Frame
Baseline, 28 days, 3 months, 6 months
Title
Changes in ICIQ-OAB Quality of Life
Description
ICIQ-OAB Qol questionnaire: is a robust, subject-completed questionnaire for evaluating quality of life (QoL) in subjects with overactive bladder, for use in research and clinical practice. The questionnaire explores in detail the impact on subject's lives of overactive bladder and can be used as an outcome measure to assess impact of different
Time Frame
Baseline, 28 days, 3 months, 6 months
Title
Changes in PGI-I
Description
Patient Global Impression of Improvement (PGI-I): The PGI-I is a subject-completed transition scale that is a single question asking the subject to rate their urinary tract condition now, as compared with how it was prior to before beginning treatment on a 7 point scale
Time Frame
Baseline, 28 days, 3 months, 6 months
Title
Changes in FSFI
Description
FSFI - questionnaire: The Female Sexual Function Index (FSFI) is a widely used multidimensional self-reported questionnaire on Female Sexual Dysfunction. It consists of 19 items and assesses 6 domains, including desire, arousal, lubrication, orgasm, satisfaction and pain.
Time Frame
Baseline, 28 days, 3 months, 6 months
Title
Technical Outcomes
Description
Number of patients successfully implanted
Time Frame
24 hours postoperatively
Title
Measurement of EMG
Description
Intra-operative and post-operative (ambulatory) measurements of electromyography
Time Frame
During procedure, 24 hours and 6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Specific urological
Urinary tract mechanical obstruction such as urethral stricture
Current symptomatic urinary tract infection (UTI) or more than 3 UTIs in past year
Pure stress incontinence or mixed incontinence where the stress component overrides the urge component
Interstitial cystitis or bladder pain syndrome as defined by either AUA or EAU guidelines
Suspected pudendal nerve entrapment syndrome. In patients with co-existent symptoms of chronic pelvic pain and urinary incontinence, Nantes criteria will be used for screening. Patients meeting essential criteria will be excluded from the study
Treatment of urinary symptoms with botulinum toxin therapy in the past 12 months
Prior attempt at pudendal nerve stimulation using an implanted lead
Treatment of urinary symptoms with tibial or sacral nerve stimulation in the past 3 months (prior experience of either before this time is permitted provided no implants remain in-situ)
Specific technical
Patient is significantly obese (defined as BMI ≥ 35) so as to limit electrode lead placement using standard approaches
Skin, orthopaedic or neurological anatomical limitations that could prevent successful placement of the electrode lead
Knowledge of planned MRIs, diathermy, microwave exposure, high output ultrasonic exposure, or RF energy exposure
Implantable neurostimulator, pacemaker or defibrillator in situ (anywhere in body including sacral and tibial)
Subject with a documented history of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Crawley
Phone
+447773326320
Email
aidan@amber-tx.com
Facility Information:
Facility Name
University Hospital Antwerp
City
Antwerp
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Derickx
Phone
+ 32 3 821 4734
Email
Katleen.Derickx@uza.be
First Name & Middle Initial & Last Name & Degree
De Wachter
12. IPD Sharing Statement
Plan to Share IPD
No
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AURA-2: Augmenting Urinary Reflex Activity
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