Overactive BladderOPTIMIST-1NCT03019094
Overactive Bladder Posterior Tibial Implantable MIcro STimulator - 1
A study testing The RENOVA tibial nerve stimulation system in people with Overactive Bladder, run by BlueWind Medical.
Trial summary
Interventional, Prospective, Open Label study Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- The RENOVA tibial nerve stimulation system
- 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 2017to Dec 2018
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent.
- Patient who is mentally competent with the ability to understand and comply with the requirements of the study.
- Patient agrees to attend all follow-up evaluations and is willing to completely and accurately fill out voiding diaries and questionnaires, and is willing to complete required exams and tests.
- Patients with overactive bladder symptoms including:
- Urinary frequency greater than or equal to 8 voids/24 hours and less than 16 voids/24 hours AND/OR
- Urinary urge incontinence of at least 2 incontinence episodes on a 3-Day voiding diary
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- If used, patients should be on stable dose of antimuscarinics and/or beta-3 adrenergic agonists for at least 6 weeks prior to enrollment and agree not to change their dose until the 3-month follow-up visit.
- If used, patients should be on a stable dose of tricyclic antidepressants and Flomax for at least 6 weeks prior to enrollment and agree not to change their dose until the 3-month follow-up visit.
- Patient who has failed conservative treatments after at least 6 months of treatment (i.e. lifestyle modification-fluid consumption, behavioral modification, and pharmacological therapy).
- Patients with no clinical evidence of a tibial motor sensory deficit.
- Patients with competent sphincter mechanism.
- Patients with normally functioning upper urinary tract and no renal failure.
- Leg circumference in the range of 20-30 cm at implantation site.
- Patients with a standard 3-Day voiding diary at baseline.
Who cannot join
- Previous participation in another study with any investigational drug or device within the past 90 days.
- Any metal or other implant in the area of BlueWind RENOVA implantation site.
- Patients who have not had stable OAB medications for at least 6 weeks.
- Patients with neurogenic bladder.
- Patients who are taking diuretics.
- Patients who have received botulinum toxin injections within the past 12 months.
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- Patients who have received or are receiving nerve stimulation therapies for OAB treatment, including Sacral Nerve Stimulation (and are still implanted) or Posterior Tibial Nerve Stimulation (during the last 3 months).
- Current pregnancy or attempting to get pregnant.
- Previous urinary incontinence surgery or implantation of artificial graft material.
- Any spinal or genitourinary surgery within the last 6 months.
- Previous abdominoperineal resection of the rectum or radical hysterectomy (female)/ prostatectomy (male).
- Skin, orthopedic or neurologic anatomical limitations that preclude implantation or/and use of the device.
- Pelvic pain disorders.
- Obvious clinically demonstrated genuine stress incontinence including mixed incontinence.
- Any neurological disease or disorder including Alzheimer's, Parkinson, Multiple Sclerosis, neuropathy or injury resulting in neuropathy.
- Current or recurrent urinary tract infection (3 or more infections in the last 6 months), or urinary tract obstruction such as benign prostatic hypertrophy, cancer, urethral stricture or presence of urinary stone.
- History of Pelvic radiotherapy and chemotherapy.
- Severe uncontrolled diabetes.
- Patients anticipating magnetic resonance imaging (MRI) exams that are not allowed in the device labeling.
- Presence of cystocele, enterocele or rectocele of grade 2 or more.
- Patients with a documented history of allergic response to Platinum iridium, Titanium, Zirconia and Parylene.
- Another active implant.
- Have a life expectancy of less than 1 year
About this study
Official title: Safety and Performance of the BlueWind RENOVA™ System for the Treatment of Patients Diagnosed With Overactive Bladder (OAB) (OPTIMIST-1 - Overactive Bladder Posterior Tibial Implantable MIcro STimulator - 1)
Interventional, Prospective, Open Label study
Read the detailed description
Generally, subjects will be followed at 1, 2, 3, 4, 6, 9 and 12-months after activation with the RENOVA System.
The study will be conducted according the following phases:
- Recruitment, baseline assessment and compatibility test: Subjects fulfilling all inclusion and none of the exclusion criteria will be enrolled to the trial. Study candidates will sign an informed consent form, complete a standard 3-Day voiding diary, a quality of life questionnaire and global response assessment. Beck Depression Inventory II and General quality of life questionnaires will be completed in selected geographies. Study eligible subjects that have not experienced Posterior Tibial Nerve Stimulation treatment in the past will undergo a compatibility test to assure proper nerve conductivity. Data collected will serve as baseline.
- Implantation: Patients with positive response to the compatibility test (or that received Posterior Tibial Nerve Stimulation treatment in the past) will undergo unilateral implantation 4±1 weeks following recruitment with the BlueWind RENOVA System. Intra-operative sensory/motor response will be tested to confirm accurate location of the implant.
- Sensation assessment and activation: After a recovery period of approximately 30±7 days, subjects will complete a Brief 3-Day voiding diary and a quality of life questionnaire and a sensation assessment will be conducted: subjects will undergo an acute stimulation session of the tibial nerve to evaluate their sensory reaction to stimulation and parameters setting will be performed according to their individual sensations. Eventually, patients will be trained for system home use treatment. Therapy will be delivered daily for a minimum of 30 minutes once a day and maximum of 1 hour per day (in 2 sessions of 30 minutes), per physician discretion. Following activation of the device, patient will complete Brief 3-day voiding diaries once a week until the 1 month follow-up visit.
- Follow-ups (1-, 2-, and 3-months post-device activation): A 3-Day voiding diary and QoL questionnaire will be collected (brief 3-Day diaries on 1-, and 2-months follow up visits; and a 3-Day standard voiding diary on the 3-month follow up). Global Response Assessment and Beck Depression Inventory II will be collected on the 3-month follow-up visit (Beck Depression Inventory in selected geographies). Stimulation parameters will be checked and adjusted as needed by: (a) changing current amplitude; and/or (b) changing stimulation frequency; and/or changing pulse width; and/or (c) changing the number of daily treatment sessions. Location of paresthesia will be recorded in each of the clinic visits. The visit at 2 months will be performed by phone call to assess the patient status. Clinic visit may be followed at the discretion of the clinical team.
- Continued follow-ups: All subjects in the trial will undergo 4 additional visits (at 4-, 6- ,9- and 12-months post-device activation) until the end of the study at the 12-month visit. Similar to the visit at 2 months, the visit at 4 months will be performed by phone call to assess the patient status. Clinic visit may be followed at the discretion of the clinical team. Three-Day voiding diary, Quality of Life questionnaire, Global Response Assessment and Beck Depression Inventory II and General quality of life questionnaires (at selected geographies) will be collected at each of those visits (except for the 4- and 9-months visit in which only a 3-Day Brief voiding diary will be collected). General quality of life questionnaire will be completed at the 12-month visit in selected geographies. Stimulation parameters will be checked and adjusted as needed. Location of paresthesia will be recorded in each of the clinic visits
- Conditions
- Overactive Bladder
- Being tested
- The RENOVA tibial nerve stimulation system
- Keywords
- overactive bladder, urge urinary incontinence, urgency frequency
- 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.
The RENOVA tibial nerve stimulation systemDevice
Study participants will be implanted with the RENOVA tibial nerve stimulation system
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Implantation of the RENOVA tibial nerve stimulation system Receives: Device: The RENOVA tibial nerve stimulation system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of serious adverse events
Incidence of serious adverse events (system and/or procedure related events)
Measured: 6 and 12 months post-activation
Clinical improvement in urge urinary incontinence
Change from baseline in number of leaking episodes per day
Measured: 3 months post-activation
Clinical improvement urinary frequency
Change from baseline in number of voids per day
Measured: 3 months post-activation
Clinical improvement in degree of urgency
Change from baseline in degree of urgency prior to void
Measured: 3 months post-activation
Secondary outcomes (9)
Change in number of leaking episodes
Change from baseline in number of leaking episodes
Measured: 6- and 12 months post activation
Change in number of voids
Change from baseline in number of voids
Measured: 6- and 12 months post activation
Change in degree of urgency prior to void
Change from baseline in degree of urgency prior to void
Measured: 6- and 12 months post activation
Change in number of absorbent pads
Change from baseline in number of Absorbent pads used due to leaking/day
Measured: 3, 6, and 12 months post activation
Change in volume voided per void
Change from baseline of Volume voided/void
Measured: 3, 6, and 12 months post activation
Change in urge urinary incontinence episodes
Change from baseline in severity of leaking episodes
Measured: 3, 6, and 12 months post activation
Change in Quality of Life
Change from baseline in quality of life
Measured: 3, 6, and 12 months post activation
Change in Global response of patient to treatment
Change from baseline in global response assessment
Measured: 3, 6, and 12 months post activation
Change in Depression indices
Change from baseline in Beck Depression Inventory II
Measured: 3, 6, and 12 months post activation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2017 (estimated)
- Study startApr 2017 (estimated)
- Primary completionMar 2018 (estimated)
- Study completionDec 2018 (estimated)
Why it stopped: Sponsor decision
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- BlueWind Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03019094
- Sponsor's protocol ID
- G01-CLP-0001
- Acronym
- OPTIMIST-1
- Status last verified
- May 2017
- First submitted
- 5 Jan 2017
- Last updated
- 16 May 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Performance of the BlueWind RENOVA™ System for the Treatment of Patients Diagnosed With Overactive Bladder (OAB) (OPTIMIST-1 - Overactive Bladder Posterior Tibial Implantable MIcro STimulator - 1)
- ClinicalTrials.gov ID
- NCT03019094
- Acronym / sponsor ID
- OPTIMIST-1 / G01-CLP-0001
- Conditions
- Overactive Bladder
- Keywords
- overactive bladder, urge urinary incontinence, urgency frequency
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- BlueWind MedicalIndustry (pharma, biotech, devices)
- Study start
- Apr 2017 (estimated)
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 12 Jan 2017 (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.
Interventional, Prospective, Open Label study
Detailed description
Generally, subjects will be followed at 1, 2, 3, 4, 6, 9 and 12-months after activation with the RENOVA System.
The study will be conducted according the following phases:
- Recruitment, baseline assessment and compatibility test: Subjects fulfilling all inclusion and none of the exclusion criteria will be enrolled to the trial. Study candidates will sign an informed consent form, complete a standard 3-Day voiding diary, a quality of life questionnaire and global response assessment. Beck Depression Inventory II and General quality of life questionnaires will be completed in selected geographies. Study eligible subjects that have not experienced Posterior Tibial Nerve Stimulation treatment in the past will undergo a compatibility test to assure proper nerve conductivity. Data collected will serve as baseline.
- Implantation: Patients with positive response to the compatibility test (or that received Posterior Tibial Nerve Stimulation treatment in the past) will undergo unilateral implantation 4±1 weeks following recruitment with the BlueWind RENOVA System. Intra-operative sensory/motor response will be tested to confirm accurate location of the implant.
- Sensation assessment and activation: After a recovery period of approximately 30±7 days, subjects will complete a Brief 3-Day voiding diary and a quality of life questionnaire and a sensation assessment will be conducted: subjects will undergo an acute stimulation session of the tibial nerve to evaluate their sensory reaction to stimulation and parameters setting will be performed according to their individual sensations. Eventually, patients will be trained for system home use treatment. Therapy will be delivered daily for a minimum of 30 minutes once a day and maximum of 1 hour per day (in 2 sessions of 30 minutes), per physician discretion. Following activation of the device, patient will complete Brief 3-day voiding diaries once a week until the 1 month follow-up visit.
- Follow-ups (1-, 2-, and 3-months post-device activation): A 3-Day voiding diary and QoL questionnaire will be collected (brief 3-Day diaries on 1-, and 2-months follow up visits; and a 3-Day standard voiding diary on the 3-month follow up). Global Response Assessment and Beck Depression Inventory II will be collected on the 3-month follow-up visit (Beck Depression Inventory in selected geographies). Stimulation parameters will be checked and adjusted as needed by: (a) changing current amplitude; and/or (b) changing stimulation frequency; and/or changing pulse width; and/or (c) changing the number of daily treatment sessions. Location of paresthesia will be recorded in each of the clinic visits. The visit at 2 months will be performed by phone call to assess the patient status. Clinic visit may be followed at the discretion of the clinical team.
- Continued follow-ups: All subjects in the trial will undergo 4 additional visits (at 4-, 6- ,9- and 12-months post-device activation) until the end of the study at the 12-month visit. Similar to the visit at 2 months, the visit at 4 months will be performed by phone call to assess the patient status. Clinic visit may be followed at the discretion of the clinical team. Three-Day voiding diary, Quality of Life questionnaire, Global Response Assessment and Beck Depression Inventory II and General quality of life questionnaires (at selected geographies) will be collected at each of those visits (except for the 4- and 9-months visit in which only a 3-Day Brief voiding diary will be collected). General quality of life questionnaire will be completed at the 12-month visit in selected geographies. Stimulation parameters will be checked and adjusted as needed. Location of paresthesia will be recorded in each of the clinic visits
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: The RENOVA tibial nerve stimulation systemImplantation of the RENOVA tibial nerve stimulation system |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Signed written informed consent.
- Patient who is mentally competent with the ability to understand and comply with the requirements of the study.
- Patient agrees to attend all follow-up evaluations and is willing to completely and accurately fill out voiding diaries and questionnaires, and is willing to complete required exams and tests.
- Patients with overactive bladder symptoms including:
- If used, patients should be on stable dose of antimuscarinics and/or beta-3 adrenergic agonists for at least 6 weeks prior to enrollment and agree not to change their dose until the 3-month follow-up visit.
Key exclusion criteria (23 listed)
- Previous participation in another study with any investigational drug or device within the past 90 days.
- Any metal or other implant in the area of BlueWind RENOVA implantation site.
- Patients who have not had stable OAB medications for at least 6 weeks.
- Patients with neurogenic bladder.
- Patients who are taking diuretics.
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 |
|---|---|---|
| The RENOVA tibial nerve stimulation systemStudy participants will be implanted with the RENOVA tibial nerve stimulation system | Device | Treatment |
Primary outcome
Incidence of serious adverse events
Time frame: 6 and 12 months post-activation
Incidence of serious adverse events (system and/or procedure related events)
Clinical improvement in urge urinary incontinence
Time frame: 3 months post-activation
Change from baseline in number of leaking episodes per day
Clinical improvement urinary frequency
Time frame: 3 months post-activation
Change from baseline in number of voids per day
Clinical improvement in degree of urgency
Time frame: 3 months post-activation
Change from baseline in degree of urgency prior to void
9 secondary outcomes
Change in number of leaking episodes
Time frame: 6- and 12 months post activation
Change in number of voids
Time frame: 6- and 12 months post activation
Change in degree of urgency prior to void
Time frame: 6- and 12 months post activation
Change in number of absorbent pads
Time frame: 3, 6, and 12 months post activation
Change in volume voided per void
Time frame: 3, 6, and 12 months post activation
Change in urge urinary incontinence episodes
Time frame: 3, 6, and 12 months post activation
Change in Quality of Life
Time frame: 3, 6, and 12 months post activation
Change in Global response of patient to treatment
Time frame: 3, 6, and 12 months post activation
Change in Depression indices
Time frame: 3, 6, and 12 months post activation
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 16 May 2017.
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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 The RENOVA tibial nerve stimulation system in people with Overactive Bladder, run by BlueWind Medical.
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 14 inclusion and 23 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 16 May 2017. 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?
Incidence of serious adverse events (time frame: 6 and 12 months post-activation). The study lists 4 primary outcomes in all. 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 16 May 2017.