Overactive BladderRELAX-OABNCT02620410
Treatment of REfractory Overactive BLadder With the AXonics Sacral Neuromodulation System (RELAX-OAB)
A study testing Axonics Sacral Neuromodulation (SNM) System in people with Overactive Bladder, run by Axonics, Inc. at 6 sites in 4 countries.
Trial summary
The RELAX-OAB (Treatment of REfractory Overactive BLadder with the AXonics Sacral Neuromodulation System) is a post-market clinical follow-up (PMCF) study designed to confirm the performance of the Axonics Sacral Neuromodulation (SNM) System as an aid in the treatment of the symptoms of overactive bladder (OAB) as… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Axonics Sacral Neuromodulation (SNM) System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 6 sitesin 4 countries
- Study dates
- Jun 2016to Jan 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of OAB as demonstrated on a 3-day voiding diary defined as ≥ 8 voids/day, and/or a minimum of 2 involuntary leaking episodes in a 72-hour period
- Positive motor response on at least two implanted electrodes during intraoperative test
- Failed, or are not a candidate for more conservative treatment (e.g., pelvic floor training, biofeedback, behavioral modification, oral pharmacotherapy)
- No changes to current regimen of medications that affect bladder function for at least 4 weeks prior to beginning the baseline voiding diary
- Willing and capable of providing informed consent
- Capable of participating in all testing associated with this clinical investigation
Who cannot join
- Primary stress incontinence or mixed incontinence where the stress component overrides the urgency component
- Current urinary tract mechanical obstruction such as benign prostatic enlargement or urethral stricture
- Interstitial cystitis or bladder pain syndrome as defined by either AUA or EAU guidelines
- History of any pelvic cancer
- 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
Show all 19Show fewer
- PHQ-9 Patient Depression Score ≥ 10
- Current symptomatic urinary tract infection (UTI) or more than 3 UTIs in past year
- Any neurological condition that may interfere with normal bladder function, including stroke, multiple sclerosis, Parkinson's disease, clinically significant peripheral neuropathy, or spinal cord injury (e.g., paraplegia)
- Severe or uncontrolled diabetes (A1C > 8, documented in the last 3 months) or diabetes with peripheral nerve involvement
- Treatment of urinary symptoms with botulinum toxin therapy in the past 12 months
- Treatment of urinary symptoms with tibial nerve stimulation in the past 3 months
- Previously implanted with a sacral neuromodulation device or participated in a sacral neuromodulation trial
- Subject with a documented history of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone
- Knowledge of planned MRIs, diathermy, or high output ultrasonic exposure
- Any other active implanted devices including neurostimulators (e.g., cochlear implant, pacemaker) and/or drug delivery pumps, whether turned on or off
- Passive implants (e.g., prostheses) are allowed, but no implanted metal should be at the Neurostimulator implant site
- A female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception
- Participation in a current clinical trial or within the preceding 30 days
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
Netherlands2 sites
Maastricht University Medical Center
Maastricht
Erasmus Medical Center
Rotterdam
About this study
The RELAX-OAB (Treatment of REfractory Overactive BLadder with the AXonics Sacral Neuromodulation System) is a post-market clinical follow-up (PMCF) study designed to confirm the performance of the Axonics Sacral Neuromodulation (SNM) System as an aid in the treatment of the symptoms of overactive bladder (OAB) as well as capturing patient satisfaction and quality of life data.
- Conditions
- Overactive Bladder
- Being tested
- Axonics Sacral Neuromodulation (SNM) System
- Keywords
- OAB
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Axonics Sacral Neuromodulation (SNM) SystemDevice
Also called Axonics SNM System
The implantable components of the Axonics Sacral Neuromodulation (SNM) System consist of an IPG and tined lead. Additional components include a clinician programmer, surgical tool kit, recharging kit, and patient remote control.
| Study group | Role | What they receive |
|---|---|---|
| Axonics SNM System | Other | Axonics SNM Therapy for urinary control is indicated for the treatment of urinary retention and the symptoms of overactive bladder, including urinary urge incontinence and significant symptoms of urgency-frequency alone or in combination, in patients who have failed or could not tolerate more conservative treatments. Receives: Device: Axonics Sacral Neuromodulation (SNM) System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in ICIQ-OABqol HRQL Total Score compared to baseline.
A disease-specific quality of life questionnaire. The ICIQ-OABqol is a psychometrically robust patient-completed questionnaire evaluating quality of life (QoL) in patients with overactive bladder for use in research and clinical practice across the world. The ICIQ-OABqol is the OAB-q adapted for use within the ICIQ structure and provides a detailed and robust measure to assess the impact of overactive bladder on quality of life. It is an ideal research tool as it explores in detail the impact on patients' lives of overactive bladder. The Third International Consultation on Incontinence recommended that all randomised trials evaluating treatments for incontinence use high quality questionnaires, in particular the ICIQ, to assess impact on patient outcome and facilitate comparisons. The ICIQ-OABqol provides a robust measure for this purpose.
Measured: 3 Months
Secondary outcomes (16)
Rate of serious adverse device effects (SADEs)
Measured: 3 Months, 1 Year, 2 Year post-implantation
Rate of adverse device effects (ADEs)
Measured: 3 Months, 1 Year, 2 Year post-implantation
Rate of adverse procedure effects (APEs)
Measured: 3 Months, 1 Year, 2 Year post-implantation
Rate of serious adverse events (SAEs)
Measured: 3 Months, 1 Year, 2 Year post-implantation
Rate of adverse events (AEs)
Measured: 3 Months, 1 Year, 2 Year post-implantation
Device performance metrics
Data recorded from the patient's devices (Device Readings)
Measured: 3 Months, 1 Year, 2 Year post-implantation
Average leaks per day (3-day voiding diary)
Measured: 3 Months, 1 Year, 2 Year post-implantation
Average voids per day (3-day voiding diary)
Measured: 3 Months, 1 Year, 2 Year post-implantation
Percent of subjects with successful treatment
Defined as either 1) a 50% improvement in the number of average leaks or the number of voids per day or 2) a return to a normal number of voids per day (<8 voids)
Measured: 3 Months, 1 Year, 2 Year post-implantation
SF-12
General quality of life questionnaire
Measured: 3 Months, 1 Year, 2 Year post-implantation
EQ-5D
Questionnaire assessing general quality of life
Measured: 3 Months, 1 Year, 2 Year post-implantation
ICIQ-UI Short Form
Quality of life questionnaire assessing urinary incontinence
Measured: 3 Months, 1 Year, 2 Year post-implantation
ICIQ-OABqol
Quality of life questionnaire assessing over active bladder
Measured: 3 Months, 1 Year, 2 Year post-implantation
I-QOL
Quality of life questionnaire assessing urinary incontinence
Measured: 3 Months, 1 Year, 2 Year post-implantation
Patient satisfaction with treatment
Questionnaire in scale format assessing treatment-specific satisfaction
Measured: 3 Months, 1 Year, 2 Year post-implantation
Healthcare utilization
Questionnaire about subject's medical treatment
Measured: 3 Months, 1 Year, 2 Year post-implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2015 (estimated)
- Study startJun 2016
- Primary completionJun 2017
- Study completionJan 2022
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Axonics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sohier Elneil, MRCOG, PhD, Principal investigator, University College London Hospital & National Hospital for Neurology & Neurosurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02620410
- Sponsor's protocol ID
- 105-0010
- Acronym
- RELAX-OAB
- Status last verified
- Aug 2024
- First submitted
- 1 Dec 2015
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of REfractory Overactive BLadder With the AXonics Sacral Neuromodulation System (RELAX-OAB)
- ClinicalTrials.gov ID
- NCT02620410
- Acronym / sponsor ID
- RELAX-OAB / 105-0010
- Conditions
- Overactive Bladder
- Keywords
- OAB
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Axonics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jan 2022 (actual)
- First posted
- 3 Dec 2015 (estimated)
- 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.
The RELAX-OAB (Treatment of REfractory Overactive BLadder with the AXonics Sacral Neuromodulation System) is a post-market clinical follow-up (PMCF) study designed to confirm the performance of the Axonics Sacral Neuromodulation (SNM) System as an aid in the treatment of the symptoms of overactive bladder (OAB) as well as capturing patient satisfaction and quality of life data.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Axonics SNM System | Other | Device: Axonics Sacral Neuromodulation (SNM) SystemAxonics SNM Therapy for urinary control is indicated for the treatment of urinary retention and the symptoms of overactive bladder, including urinary urge incontinence and significant symptoms of urgency-frequency alone or in combination, in patients who have failed or could not tolerate more conservative treatments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of OAB as demonstrated on a 3-day voiding diary defined as ≥ 8 voids/day, and/or a minimum of 2 involuntary leaking episodes in a 72-hour period
- Positive motor response on at least two implanted electrodes during intraoperative test
- Failed, or are not a candidate for more conservative treatment (e.g., pelvic floor training, biofeedback, behavioral modification, oral pharmacotherapy)
- No changes to current regimen of medications that affect bladder function for at least 4 weeks prior to beginning the baseline voiding diary
- Willing and capable of providing informed consent
Key exclusion criteria (19 listed)
- Primary stress incontinence or mixed incontinence where the stress component overrides the urgency component
- Current urinary tract mechanical obstruction such as benign prostatic enlargement or urethral stricture
- Interstitial cystitis or bladder pain syndrome as defined by either AUA or EAU guidelines
- History of any pelvic cancer
- Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound evaluation of study endpoints
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 |
|---|---|---|
| Axonics Sacral Neuromodulation (SNM) SystemAlso: Axonics SNM SystemThe implantable components of the Axonics Sacral Neuromodulation (SNM) System consist of an IPG and tined lead. Additional components include a clinician programmer, surgical tool kit, recharging kit, and patient remote control. | Device | Axonics SNM System |
Primary outcome
Mean change in ICIQ-OABqol HRQL Total Score compared to baseline.
Time frame: 3 Months
A disease-specific quality of life questionnaire. The ICIQ-OABqol is a psychometrically robust patient-completed questionnaire evaluating quality of life (QoL) in patients with overactive bladder for use in research and clinical practice across the world. The ICIQ-OABqol is the OAB-q adapted for use within the ICIQ structure and provides a detailed and robust measure to assess the impact of overactive bladder on quality of life. It is an ideal research tool as it explores in detail the impact on patients' lives of overactive bladder. The Third International Consultation on Incontinence recommended that all randomised trials evaluating treatments for incontinence use high quality questionnaires, in particular the ICIQ, to assess impact on patient outcome and facilitate comparisons. The ICIQ-OABqol provides a robust measure for this purpose.
16 secondary outcomes
Rate of serious adverse device effects (SADEs)
Time frame: 3 Months, 1 Year, 2 Year post-implantation
Rate of adverse device effects (ADEs)
Time frame: 3 Months, 1 Year, 2 Year post-implantation
Rate of adverse procedure effects (APEs)
Time frame: 3 Months, 1 Year, 2 Year post-implantation
Rate of serious adverse events (SAEs)
Time frame: 3 Months, 1 Year, 2 Year post-implantation
Rate of adverse events (AEs)
Time frame: 3 Months, 1 Year, 2 Year post-implantation
Device performance metrics
Time frame: 3 Months, 1 Year, 2 Year post-implantation
Average leaks per day (3-day voiding diary)
Time frame: 3 Months, 1 Year, 2 Year post-implantation
Average voids per day (3-day voiding diary)
Time frame: 3 Months, 1 Year, 2 Year post-implantation
Percent of subjects with successful treatment
Time frame: 3 Months, 1 Year, 2 Year post-implantation
SF-12
Time frame: 3 Months, 1 Year, 2 Year post-implantation
EQ-5D
Time frame: 3 Months, 1 Year, 2 Year post-implantation
ICIQ-UI Short Form
Time frame: 3 Months, 1 Year, 2 Year post-implantation
ICIQ-OABqol
Time frame: 3 Months, 1 Year, 2 Year post-implantation
I-QOL
Time frame: 3 Months, 1 Year, 2 Year post-implantation
Patient satisfaction with treatment
Time frame: 3 Months, 1 Year, 2 Year post-implantation
Healthcare utilization
Time frame: 3 Months, 1 Year, 2 Year post-implantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
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Overactive Bladder (OAB)
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.
Sohier Elneil, MRCOG, PhD principal investigator
University College London Hospital & National Hospital for Neurology & Neurosurgery
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Axonics Sacral Neuromodulation (SNM) System in people with Overactive Bladder, run by Axonics, Inc. at 6 sites in 4 countries.
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 6 inclusion and 19 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: finished, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France, Netherlands, Belgium, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean change in ICIQ-OABqol HRQL Total Score compared to baseline. (time frame: 3 Months). 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 9 Aug 2024.