Overactive Bladder Posterior Tibial Implantable MIcro STimulator - 1 (OPTIMIST-1)

May 15, 2017 updated by: BlueWind Medical

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

Study Overview

Status

Status

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Withdrawn

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.

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 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

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

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Signed written informed consent.
  2. Patient who is mentally competent with the ability to understand and comply with the requirements of the study.
  3. 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.

  4. 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
  5. 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.
  6. 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.
  7. Patient who has failed conservative treatments after at least 6 months of treatment (i.e. lifestyle modification-fluid consumption, behavioral modification, and pharmacological therapy).
  8. Patients with no clinical evidence of a tibial motor sensory deficit.
  9. Patients with competent sphincter mechanism.
  10. Patients with normally functioning upper urinary tract and no renal failure.
  11. Leg circumference in the range of 20-30 cm at implantation site.
  12. Patients with a standard 3-Day voiding diary at baseline.

Exclusion Criteria:

  1. Previous participation in another study with any investigational drug or device within the past 90 days.
  2. Any metal or other implant in the area of BlueWind RENOVA implantation site.
  3. Patients who have not had stable OAB medications for at least 6 weeks.
  4. Patients with neurogenic bladder.
  5. Patients who are taking diuretics.
  6. Patients who have received botulinum toxin injections within the past 12 months.
  7. 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).
  8. Current pregnancy or attempting to get pregnant.
  9. Previous urinary incontinence surgery or implantation of artificial graft material.
  10. Any spinal or genitourinary surgery within the last 6 months.
  11. Previous abdominoperineal resection of the rectum or radical hysterectomy (female)/ prostatectomy (male).
  12. Skin, orthopedic or neurologic anatomical limitations that preclude implantation or/and use of the device.
  13. Pelvic pain disorders.
  14. Obvious clinically demonstrated genuine stress incontinence including mixed incontinence.
  15. Any neurological disease or disorder including Alzheimer's, Parkinson, Multiple Sclerosis, neuropathy or injury resulting in neuropathy.
  16. 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.
  17. History of Pelvic radiotherapy and chemotherapy.
  18. Severe uncontrolled diabetes.
  19. Patients anticipating magnetic resonance imaging (MRI) exams that are not allowed in the device labeling.
  20. Presence of cystocele, enterocele or rectocele of grade 2 or more.
  21. Patients with a documented history of allergic response to Platinum iridium, Titanium, Zirconia and Parylene.
  22. Another active implant.
  23. Have a life expectancy of less than 1 year

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: N/A
  • Interventional Model: Single Group 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: Treatment
Implantation of the RENOVA tibial nerve stimulation system
Device: The RENOVA tibial nerve stimulation system
Study participants will be implanted with the RENOVA tibial nerve stimulation 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
Incidence of serious adverse events
Time Frame: 6 and 12 months post-activation
Incidence of serious adverse events (system and/or procedure related events)
6 and 12 months post-activation
Clinical improvement in urge urinary incontinence
Time Frame: 3 months post-activation
Change from baseline in number of leaking episodes per day
3 months post-activation
Clinical improvement urinary frequency
Time Frame: 3 months post-activation
Change from baseline in number of voids per day
3 months post-activation
Clinical improvement in degree of urgency
Time Frame: 3 months post-activation
Change from baseline in degree of urgency prior to void
3 months post-activation

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
Change in number of leaking episodes
Time Frame: 6- and 12 months post activation
Change from baseline in number of leaking episodes
6- and 12 months post activation
Change in number of voids
Time Frame: 6- and 12 months post activation
Change from baseline in number of voids
6- and 12 months post activation
Change in degree of urgency prior to void
Time Frame: 6- and 12 months post activation
Change from baseline in degree of urgency prior to void
6- and 12 months post activation
Change in number of absorbent pads
Time Frame: 3, 6, and 12 months post activation
Change from baseline in number of Absorbent pads used due to leaking/day
3, 6, and 12 months post activation
Change in volume voided per void
Time Frame: 3, 6, and 12 months post activation
Change from baseline of Volume voided/void
3, 6, and 12 months post activation
Change in urge urinary incontinence episodes
Time Frame: 3, 6, and 12 months post activation
Change from baseline in severity of leaking episodes
3, 6, and 12 months post activation
Change in Quality of Life
Time Frame: 3, 6, and 12 months post activation
Change from baseline in quality of life
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 from baseline in global response assessment
3, 6, and 12 months post activation
Change in Depression indices
Time Frame: 3, 6, and 12 months post activation
Change from baseline in Beck Depression Inventory II
3, 6, and 12 months post activation

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.
BlueWind Medical

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 (Anticipated)

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.
April 1, 2017

Primary Completion (Anticipated)

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.
March 1, 2018

Study Completion (Anticipated)

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.
December 1, 2018

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).
January 5, 2017

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.
January 10, 2017

First Posted (Estimate)

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.
January 12, 2017

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 16, 2017

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 15, 2017

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.
May 1, 2017

More Information

Terms related to this study

Keywords

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.
  • G01-CLP-0001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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