RESTORE: An RCT to Evaluate the Efficacy of the Revi System

April 7, 2024 updated by: BlueWind Medical

A Prospective Randomized Control Trial to Compare the Efficacy of the Revi System Therapy on Versus Off in Relieving Urinary Urge Incontinence Episodes.

The Revi System is indicated for the treatment of patients with symptoms of urgency incontinence alone or in combination with urinary urgency.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Prospective, multi-center, open label, post market, randomized controlled trial

To demonstrate superiority of Revi System therapy vs. non active therapy in the treatment of UUI

Treatment Arm:

Device: Revi System Subjects will be implanted with a Revi System and activation of therapy will occur ~4 weeks post implantation and continue for the duration of the study.

Control Arm:

Device: Revi System - Delayed Activation Subjects will be implanted with a Revi System and activation of therapy will be delayed until 4 months post implantation. At this time the Revi System will be activated to begin therapy and will continue for the duration of the study.

Randomization in a 1:2 ratio into either the "control group" or the "treatment group" will be performed in blocks of 3 or 6 randomly, across the study population by a central randomization system. Randomization will be stratified by investigational site.

The study will consist of the following activities:

Visit 1 - Screening

  • Potential subjects with UUI, who fulfil basic criteria will be informed of the study and will be invited to sign an informed consent form.
  • Demographic information (age, race, height and weight, leg circumference), medical and surgical history and concomitant medication information will be collected.
  • Study candidates will be asked to fill out various questionnaires
  • Patients will be asked to complete a 3- consecutive day voiding diary.
  • Urine sample will be collected, blood will be drawn and a full physical examination, including a PVR measurement and uroflow (in men), will be performed.

Visit 2 - Randomization & Implantation

  • 5 ± 4 weeks after starting the diary, eligible subjects will be randomized to either the Treatment or Control (delayed activation) arms (2:1) and will undergo unilateral implantation with the BlueWind Revi System
  • Collection of AE and concomitant medication will be performed

Treatment Arm:

Visit 3 - Activation

  • After a recovery period of 4-weeks post implantation, subjects will attend the clinic to undergo physical examination and surgical wound check-up.
  • Subjects will undergo parameter setting according to the individual patient sensations and will be trained on the use of the system.

Visits 4-11 - Treatment optimization and follow up

  • Follow-up visits will be performed at 1, 2, 3, 6, 9, 12, and 24 months post system activation.
  • A call visit will be performed at 18-months.
  • All follow-up visits will require completion of a 3-day voiding diary by the patient before coming to the visit.
  • During each clinic visit, stimulation parameters and level of treatment will be checked and adjusted as needed.

Control Arm:

• After a recovery period of 1-month post implantation, subjects will attend the clinic to undergo physical examination and surgical wound check-up.

Visit 4 - Activation

  • After a recovery period of 4-weeks post implantation, subjects will attend the clinic to undergo physical examination and surgical wound check-up.
  • Subjects will undergo parameter setting according to the individual patient sensations and will be trained on the use of the system.

Visits 5-12 - Treatment optimization and follow up

  • Follow-up visits will be performed at 1, 2, 3, 6, 9, 12, and 24 months post system activation.
  • A call visit will be performed at 18-months.
  • All follow-up visits will require completion of a 3-day voiding diary by the patient before coming to the visit.
  • During each clinic visit, stimulation parameters and level of treatment will be checked and adjusted as needed.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • University of Alabama at Birmingham
        • Contact:
        • Principal Investigator:
          • Adam Baumgarten, MD
    • Arizona
      • Tucson, Arizona, United States, 85741
        • Recruiting
        • Arizona Urology Specialists
        • Contact:
        • Principal Investigator:
          • Mitzi Barmatz, MD
    • California
      • Pasadena, California, United States, 91101
        • Recruiting
        • Pasadena Urology
        • Contact:
        • Principal Investigator:
          • Shahin Chandrasoma, MD
      • Riverside, California, United States, 92506
        • Recruiting
        • Riverside Medical Clinic
        • Contact:
        • Contact:
        • Principal Investigator:
          • Erin Katz, MD
        • Sub-Investigator:
          • Benjamin Yang, MD
    • Florida
      • Tampa, Florida, United States, 33615
        • Recruiting
        • Florida Urology Partners
        • Principal Investigator:
          • Osvaldo Padron, MD
        • Contact:
        • Sub-Investigator:
          • Alonso Alvarez, MD
    • Louisiana
      • Shreveport, Louisiana, United States, 71103
        • Recruiting
        • Willis-Knighton Clinical Research
        • Principal Investigator:
          • Gerard Henry, MD
        • Contact:
    • Maryland
      • Owings Mills, Maryland, United States, 21117
        • Recruiting
        • Chesapeake Urology
        • Principal Investigator:
          • Laura Giusto, MD
        • Contact:
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Recruiting
        • Specialty Clinical Research of St. Louis, LLC
        • Contact:
        • Principal Investigator:
          • Travis Bullock, M.D.
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Recruiting
        • Adult and Pediatric Urology and Urogynecology
        • Principal Investigator:
          • Rebecca McCrery, MD
        • Contact:
        • Sub-Investigator:
          • Emily Kean, MD
    • New York
      • Bronx, New York, United States, 10461
        • Not yet recruiting
        • Montefiore Medical Center
        • Contact:
        • Principal Investigator:
          • Melissa Laudano, MD
        • Sub-Investigator:
          • Nitya Abraham, MD
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • University Hospitals Cleveland Medical Center
        • Principal Investigator:
          • Adonis Hijaz, MD
        • Contact:
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
    • Texas
      • Arlington, Texas, United States, 76017
        • Recruiting
        • Urology Partners of North Texas
        • Principal Investigator:
          • Keith Xavier, MD
        • Contact:
      • Dallas, Texas, United States, 75390
        • Not yet recruiting
        • University of Texas Southwestern - Department of Urology
        • Contact:
        • Principal Investigator:
          • Maude Carmel, MD
      • Edinburg, Texas, United States, 78539
        • Recruiting
        • DHR Health Institute for Research and Development
        • Contact:
        • Principal Investigator:
          • Henry Ruiz, MD
      • San Antonio, Texas, United States, 78240
        • Recruiting
        • The Urology Place
        • Principal Investigator:
          • Naveen Kella, MD
        • Contact:
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Not yet recruiting
        • University of Utah
        • Contact:
        • Principal Investigator:
          • Sara Lenherr, MD

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Signed written informed consent.
  2. Subject is at least 21 years old, with no plans to become pregnant during the trial. If of child bearing potential and sexually active, negative pregnancy test and using acceptable contraception.
  3. Subject has been diagnosed with UUI for at least 6 months.
  4. Subject experiences a minimum of four (4) leaking episodes associated with urgency, with at least one episode per day for 2 days documented on a voiding diary for 3 consecutive days.
  5. If used, subject should be on stable dose of antimuscarinics and/or beta-3 adrenergic agonists for at least 1 month prior to baseline and agree to remain on stable medication consumption until the 24-month follow-up visit.
  6. If used, subject should be on a stable dose of tricyclic antidepressants, Selective Serotonin Reuptake Inhibitors (SSRI) and Serotonin-Norepinephrine Reuptake Inhibitors (SNRI) for at least 3 months prior to baseline.
  7. Subject agrees to attend all follow-up evaluations and is willing and capable to completely and accurately fill out voiding diaries and questionnaires and is willing to complete required exams and test

Exclusion Criteria:

  1. Subject participation in a clinical investigation with an active treatment arm within the past 90 days.
  2. Subject is a high surgical risk with multiple illnesses or active general infections that expose them to excessive bleeding or delayed or non-healing wounds. This includes patients who need anticoagulation therapy that cannot be temporarily stopped for the implantation procedure.
  3. Subject with BMI >50.
  4. Subject with any metal or other implant within 20cm distance of the area of BlueWind Revi implantation site.
  5. Subject variation in diuretics consumption within the last 6 months.
  6. Subject has received botulinum toxin injections for OAB within the past 12 months.
  7. Subject with previous urinary incontinence surgery or prolapse surgery within the last 12 months.
  8. Subject has had any spinal or genitourinary surgery within the last 6 months.
  9. Subject had previous abdominoperineal resection of the rectum or radical hysterectomy (female)/ prostatectomy (male).
  10. Subject with diagnosis of BPH with outflow/obstructive predominant symptoms.
  11. Subject has skin, peripheral edema, orthopedic or neurologic anatomical limitations that preclude implantation or/and use of the device.
  12. Subject with Alzheimer's, Parkinson, MS, stroke (CVI), neuropathy or injury resulting in neuropathy and/or suspected neurogenic bladder.
  13. Subject has recurrent urinary tract infections (3 or more infections in the last 6 months), or presence of urinary fistula, or urinary tract obstruction such as cancer, urethral stricture or presence of urinary stone.
  14. Subject with history of chemotherapy or pelvic radiotherapy that might have affected bladder control or caused neuropathies (i.e. peripheral neuropathy).
  15. Male subject who have obstructive Benign Prostatic Hyperplasia (BPH) or other lower urinary tract obstructions.
  16. Subject has open wounds or sores on the lower leg or foot or had previous, unhealed trauma in the implant area or has pitting edema (≥2+) in the lower leg.
  17. Subject has Venous or Arterial disease/insufficiency in the lower leg or Vasculitis or dermatologic condition in the lower leg or infections near the implantation site in the lower leg.
  18. Subject has a documented history of allergic response to Platinum iridium, Titanium, Zirconia, Gold, Silicone or Parylene.
  19. Subject has other active implantable electronic device/s regardless of whether stimulation is ON or OFF.
  20. Subject has 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: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Device: Revi System Treatment Arm
Subjects will be implanted with a Revi System and activation of therapy will occur ~4 weeks post implantation and continue for the duration of the study.
Device: Revi System Treatment
The Revi System is an implantable neuromodulation device placed in the ankle region that is activated by a battery-operated rechargeable external wearable
Other: Device: Revi System - Delayed Activation Control Arm
Subjects will be implanted with a Revi System and activation of therapy will be delayed until 4 months post implantation. At this time the Revi System will be activated to begin therapy and will continue for the duration of the study.
Device: Revi System - Delayed Activation
The Revi System is an implantable neuromodulation device placed in the ankle region that is activated by a battery-operated rechargeable external wearable. The system will be implanted but it will not be turned on until 4 months post implant procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Endpoint
Time Frame: Month 4
Superiority of active Revi therapy over non-active therapy in the treatment of subjects with urinary urge incontinence based on a 3-day voiding diary
Month 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BlueWind Medical

Investigators

  • Study Director: Lori Fein, 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 (Actual)

February 24, 2024

Primary Completion (Estimated)

May 31, 2025

Study Completion (Estimated)

May 31, 2027

Study Registration Dates

First Submitted

January 3, 2024

First Submitted That Met QC Criteria

January 11, 2024

First Posted (Actual)

January 22, 2024

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 7, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • G02-CLP-0019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

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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