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New treatment option for Hematuria - Cause Not Known
Official title Study to Assess the Impact of the Urine Test Cxbladder Triage Plus on the Number of Cystoscopies Performed on Patients With Invisible Blood in Their Urine.
ClinicalTrials.gov ID: NCT06394869
What this study is testing
- What it's testing
- This study includes adult patients who see a urologist because of blood in their urine. The amount is so small it can only be seen with a microscope.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 88
You may be able to join if
- Patient is referred for assessment of recent hematuria, defined as either:
- Microscopic hematuria (≥3 RBC/HPF or equivalent) on urine microscopy obtained within 180 days prior to enrollment, OR
- Hematuria detected by dipstick analysis (≥2+ blood or equivalent) at referral and confirmed on the same calendar day and prior to enrollment, with...
- Physically able to provide a voided urine sample from a bladder that has not been surgically altered.
- Able to give informed, written consent.
You likely can't join if
- Prior history of bladder malignancy.
- Prior history of upper tract UC or prostatic urethral UC.
- History of gross hematuria requiring instrumentation or hospitalization within the last 12 months
- Reconstructed or diverted bladder (e.g., bladder augmentation, ileal conduit, Indiana pouch)
- Indication to recommend cystoscopy other than MH (e.g., bothersome benign prostatic hyperplasia symptoms and desires a procedure, weak stream with...
- Cystoscopy contraindicated due to another condition or anatomy.
See the full eligibility criteria
- Patient is referred for assessment of recent hematuria, defined as either:
- Microscopic hematuria (≥3 RBC/HPF or equivalent) on urine microscopy obtained within 180 days prior to enrollment, OR
- Hematuria detected by dipstick analysis (≥2+ blood or equivalent) at referral and confirmed on the same calendar day and prior to enrollment, with urine microscopy collected on the same day as enrollment
- Physically able to provide a voided urine sample from a bladder that has not been surgically altered.
- Able to give informed, written consent.
- Able and willing to comply with study requirements.
- Must be 19 or the legal age of consent in the jurisdiction in which the study is taking place to 88 years of age inclusive, at the time of signing the informed consent.
- Ability to comprehend written and spoken English sufficiently to independently follow all study procedures. Or ability to comprehend Spanish with access to an English-Spanish interpreter for all study related verbal...
- Prior history of bladder malignancy.
- Prior history of upper tract UC or prostatic urethral UC.
- History of gross hematuria requiring instrumentation or hospitalization within the last 12 months
- Reconstructed or diverted bladder (e.g., bladder augmentation, ileal conduit, Indiana pouch)
- Indication to recommend cystoscopy other than MH (e.g., bothersome benign prostatic hyperplasia symptoms and desires a procedure, weak stream with concerns for urethral stricture).
- Cystoscopy contraindicated due to another condition or anatomy.
- History of pelvic radiation.
- Currently receiving systemic chemotherapy or has had systemic chemotherapy within the last 6 weeks.
- History of schistosomiasis.
- History of chronic (\>3 months) indwelling Foley catheter or chronic (\>3 months) bladder stones.
- Known current pregnancy
The study team makes the final eligibility decision.
Where it's taking place
- Homewood, Alabama, United States
- Mobile, Alabama, United States
- Fresno, California, United States
- Los Angeles, California, United States
- Daytona Beach, Florida, United States
- Merrillville, Indiana, United States
- Lafayette, Louisiana, United States
- Hanover, Maryland, United States
- Voorhees Township, New Jersey, United States
- Albany, New York, United States
- New York, New York, United States
- Poughkeepsie, New York, United States
- Dayton, Ohio, United States
- Hershey, Pennsylvania, United States
- Nashville, Tennessee, United States
- Austin, Texas, United States
- Dallas, Texas, United States
- Madison, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 88 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Homewood, Alabama, United States; Mobile, Alabama, United States; Fresno, California, United States; Los Angeles, California, United States; Daytona Beach, Florida, United States; Merrillville, Indiana, United States and 12 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.