Overactive BladderAURA1NCT05256498
AURA 1: Augmenting Urinary Reflex Activity: Study 1
A study testing Picostim Amber in people with Overactive Bladder and Urge Incontinence, run by Amber Therapeutics Ltd.
Trial summary
AURA 1 (Augmenting Urinary Reflex Activity: study 1) is a study that evaluates the electrophysiological responses of pudendal nerve stimulation using short-duration extracorporeal stimulation Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Overactive Bladder, Urge Incontinence
- What is being tested?
- Picostim Amber
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2022to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged ≥ 18 years with urological indications (OAB, UUI, UFS, retention syndromes and pain)
- Meeting criteria for routine SNM (primary or revision surgery) at the discretion of their normal care urologist.
- Ability and willingness to give informed consent
- Willingness to stay overnight in hospital after SNM procedure (as per routine care)
Who cannot join
- Patient is pregnant, breastfeeding, or plans to become pregnant during the course of the study (pregnancy tests provided in schedule) [this is an exclusion for SNM in any case]
- 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
- 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
Show all 16Show fewer
- Patient has proven major autoimmune disease, e.g. scleroderma or immunodeficiency (including use of biologic immunomodulatory drugs at time of procedure)
- 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 24h while the extracorporeal lead is in situ.
- Specific urological
- As per routine clinical SNM criteria (see: https://www.nice.org.uk/guidance/ipg6434)
- 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
- Subject with a documented history of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone
About this study
Official title: Electrophysiological Studies of the Human Pudendal Nerve Using Short-duration Extracorporeal Stimulation
AURA 1 (Augmenting Urinary Reflex Activity: study 1) is a study that evaluates the electrophysiological responses of pudendal nerve stimulation using short-duration extracorporeal stimulation
- Conditions
- Overactive Bladder, Urge Incontinence
- Being tested
- Picostim Amber
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Picostim AmberDevice
Picostim Amber temporary (24h) lead placement and extracorporeal stimulation
| Study group | Role | What they receive |
|---|---|---|
| Amber UI Stimulation | Experimental | Short-duration pudendal nerve stimulation Receives: Device: Picostim Amber |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative pelvic floor electromyography (EMG)
Intra-operative measurements of amplitude of pelvic floor EMG upon pudendal nerve stimulation
Measured: 24 Hours
Secondary outcomes (2)
Pelvic floor electromyography (EMG)
Amplitude pelvic floor EMG upon pudendal nerve stimulation
Measured: 24 Hours
Technical outcomes
Number of successfully implanted leads
Measured: 24 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study startApr 2022 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Why it stopped: Merged with other study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amber Therapeutics Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05256498
- Sponsor's protocol ID
- Amber AURA1
- Acronym
- AURA1
- Status last verified
- Jan 2023
- First submitted
- 24 Jan 2022
- Last updated
- 2 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrophysiological Studies of the Human Pudendal Nerve Using Short-duration Extracorporeal Stimulation
- ClinicalTrials.gov ID
- NCT05256498
- Acronym / sponsor ID
- AURA1 / Amber AURA1
- Conditions
- Overactive Bladder, Urge Incontinence
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Merged with other study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Amber Therapeutics LtdIndustry (pharma, biotech, devices)
- Study start
- Apr 2022 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 25 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
AURA 1 (Augmenting Urinary Reflex Activity: study 1) is a study that evaluates the electrophysiological responses of pudendal nerve stimulation using short-duration extracorporeal stimulation
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Amber UI Stimulation | Experimental | Device: Picostim AmberShort-duration pudendal nerve stimulation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female patients aged ≥ 18 years with urological indications (OAB, UUI, UFS, retention syndromes and pain)
- Meeting criteria for routine SNM (primary or revision surgery) at the discretion of their normal care urologist.
- Ability and willingness to give informed consent
- Willingness to stay overnight in hospital after SNM procedure (as per routine care)
Key exclusion criteria (16 listed)
- Patient is pregnant, breastfeeding, or plans to become pregnant during the course of the study (pregnancy tests provided in schedule) [this is an exclusion for SNM in any case]
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Picostim AmberPicostim Amber temporary (24h) lead placement and extracorporeal stimulation | Device | Amber UI Stimulation |
Primary outcome
Intraoperative pelvic floor electromyography (EMG)
Time frame: 24 Hours
Intra-operative measurements of amplitude of pelvic floor EMG upon pudendal nerve stimulation
2 secondary outcomes
Pelvic floor electromyography (EMG)
Time frame: 24 Hours
Technical outcomes
Time frame: 24 Hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Picostim Amber in people with Overactive Bladder and Urge Incontinence, run by Amber Therapeutics Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative pelvic floor electromyography (EMG) (time frame: 24 Hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2023.