ACTIVE_NOT_RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2024-02-24

Study Completion:2027-02-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06217328

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.

Ages Eligible for Study:21 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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.

Inclusion Criteria

Exclusion 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

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.

Contacts and Locations

Principal Investigator

Lori Fein

STUDY_DIRECTOR

BlueWind Medical

Study Locations (Sites)

Arizona Urology Specialists

Tucson, Arizona, 85741

United States

Pasadena Urology

Pasadena, California, 91101

United States

Riverside Medical Clinic

Riverside, California, 92506

United States

Florida Urology Partners

Tampa, Florida, 33615

United States

University of Chicago

Chicago, Illinois, 60637

United States

Duly Health

Lombard, Illinois, 60148

United States

Willis-Knighton Clinical Research

Shreveport, Louisiana, 71103

United States

Chesapeake Urology

Owings Mills, Maryland, 21117

United States

Specialty Clinical Research of St. Louis, LLC

St Louis, Missouri, 63141

United States

Adult and Pediatric Urology and Urogynecology

Omaha, Nebraska, 68114

United States

Montefiore Medical Center

The Bronx, New York, 10461

United States

Duke Urogynecology - Duke University

Durham, North Carolina, 27707

United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106

United States

Sanford Female Pelvic Medicine & Reconstructive Surgery Clinic

Sioux Falls, South Dakota, 57105

United States

Urology Partners of North Texas

Arlington, Texas, 76017

United States

University of Texas Southwestern - Department of Urology

Dallas, Texas, 75390

United States

DHR Health Institute for Research and Development

Edinburg, Texas, 78539

United States

The Urology Place

San Antonio, Texas, 78240

United States

University of Utah

Salt Lake City, Utah, 84112

United States

Collaborators and Investigators

Sponsor: BlueWind Medical

Lori Fein, STUDY_DIRECTOR, 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 Registration Dates

Study Start Date2024-02-24

Study Completion Date2027-02-28

Study Record Updates

Study Start Date2024-02-24

Study Completion Date2027-02-28

Terms related to this study

Additional Relevant MeSH Terms

Urinary Urge Incontinence