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Procedure

Device: Revi System Treatment Arm for Urge Incontinence

N/A

Recruiting

Research Sponsored by BlueWind Medical

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject has been diagnosed with UUI for at least 6 months

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 4

Awards & highlights

Study Summary

This trial is testing a system called Revi that is used to treat patients who have symptoms of urgency incontinence. It can be used alone or in combination with urinary urgency.

Who is the study for?

This trial is for individuals experiencing urge incontinence or a combination of urge urinary incontinence and urgency. Specific eligibility details are not provided, but typically participants must meet certain health criteria to be included.Check my eligibility

What is being tested?

The RESTORE trial is testing the Revi System's effectiveness for treating symptoms of urgency incontinence. Participants will receive either immediate or delayed treatment with the Revi System to compare outcomes.See study design

What are the potential side effects?

Potential side effects of the Revi System are not detailed here, but may include discomfort at the site of treatment, possible infection risk, and other device-specific reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have had urinary urgency issues for at least 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 4

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 4

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 4 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Primary Endpoint

Trial Design

2Treatment groups

Experimental Treatment

Group I: Device: Revi System Treatment ArmExperimental Treatment1 Intervention

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.

Group II: Device: Revi System - Delayed Activation Control ArmExperimental Treatment1 Intervention

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

BlueWind MedicalLead Sponsor

9 Previous Clinical Trials

532 Total Patients Enrolled

Lori FeinStudy DirectorBlueWind Medical

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of participants enrolled in this clinical study?

"Indeed, as per the information available on clinicaltrials.gov, this trial is currently in search of eligible participants. The trial was initially posted on January 24th, 2024 and has been recently updated on January 11th, 2024. Its goal is to recruit a total of 150 patients from two designated locations."

Answered by AI

Are new participants currently being enrolled in this ongoing clinical trial?

"Indeed, according to clinicaltrials.gov, this ongoing clinical trial is actively seeking individuals to participate. The trial was initially posted on January 24th, 2024 and has been recently updated on January 11th, 2024."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "RESTORE: An RCT to Evaluate the Efficacy of the Revi System". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06217328.

All > Pflugerville Tx > Fort Worth