Active — Not RecruitingNot Applicable

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

United States150 participantsStarted 2024-02-24

Plain-language summary

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

Age range21 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Signed written informed consent.
✓. 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.
✓. Subject has been diagnosed with UUI for at least 6 months.
✓. 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.
✓. 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.
✓. 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.
✓. 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

✕. Subject participation in a clinical investigation with an active treatment arm within the past 90 days.
✕. 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.
✕. Subject with BMI \>50.
✕. Subject with any metal or other implant within 20cm distance of the area of BlueWind Revi implantation site.
✕. Subject variation in diuretics consumption within the last 6 months.
✕. Subject has received botulinum toxin injections for OAB within the past 12 months.
✕. Subject with previous urinary incontinence surgery or prolapse surgery within the last 12 months.
✕. Subject has had any spinal or genitourinary surgery within the last 6 months.

Primary Endpoint

Timeframe: Month 4

NCT IDNCT06217328

SponsorBlueWind Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-02-28

Who can participate

Age range21 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Signed written informed consent.
✓. 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.
✓. Subject has been diagnosed with UUI for at least 6 months.
✓. 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.
✓. 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.
✓. 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.
✓. 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

✕. Subject participation in a clinical investigation with an active treatment arm within the past 90 days.
✕. 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.
✕. Subject with BMI \>50.
✕. Subject with any metal or other implant within 20cm distance of the area of BlueWind Revi implantation site.
✕. Subject variation in diuretics consumption within the last 6 months.
✕. Subject has received botulinum toxin injections for OAB within the past 12 months.
✕. Subject with previous urinary incontinence surgery or prolapse surgery within the last 12 months.
✕. Subject has had any spinal or genitourinary surgery within the last 6 months.