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Procedure

Revi System 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

Must not have

Subject has had any spinal or genitourinary surgery within the last 6 months

Subject with diagnosis of BPH with outflow/obstructive predominant symptoms

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 4

Awards & highlights

No Placebo-Only Group

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.

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.

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had spinal or urinary system surgery in the last 6 months.

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I have been diagnosed with BPH and experience difficulty urinating.

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I have a neurological condition like Alzheimer's, Parkinson's, MS, stroke, or neuropathy.

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I have had 3 or more urinary tract infections in the last 6 months, or I have a urinary fistula or blockage.

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I am a man with urinary blockage due to enlarged prostate or other causes.

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I have open wounds or swelling in my lower leg or foot.

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My BMI is over 50.

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I have blood vessel problems or skin conditions in my lower leg.

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I have had surgery to remove my rectum, uterus (if female), or prostate (if male).

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I have a condition that prevents me from using certain medical devices.

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I have health issues that make surgery risky for me, including problems that could cause excessive bleeding or healing issues.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Primary Endpoint

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 12Eligibility criteria met