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Urethral Expander System
ProVee Urethral Expander System for Benign Prostatic Hyperplasia (ProVIDE Trial)
Verified Trial
N/A
Recruiting
Research Sponsored by ProVerum Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have you been told that you have an enlarged prostate?
Do you live full-time in the zip code that you provided?
Must not have
Have you had any procedures performed on your prostate?
Have you had urinary stones or blood in the urine in the past 3 months?
Timeline
Screening 3 weeks
Treatment Varies
Follow Up procedure to 12 months
Awards & highlights
ProVIDE Trial Summary
This trial is studying a device to treat urinary obstruction caused by an enlarged prostate.
Who is the study for?
Men with symptoms of urinary obstruction due to benign prostatic hyperplasia (BPH), who haven't had prostate/bladder cancer, urinary stones, blood in urine recently, or prior prostate procedures. Candidates should not be on medications like finasteride or dutasteride for urination issues and have a prostate size between 30 cc and 80 cc.Check my eligibility
What is being tested?
The trial is testing the ProVee Urethral Expander System's safety and effectiveness compared to a standard urethral access sheath in men with BPH-related urinary problems. The goal is to see if this new device can improve symptoms by expanding the urethra.See study design
What are the potential side effects?
Potential side effects may include discomfort during insertion, risk of infection, possible injury to the urethra or surrounding tissues, bleeding, and temporary increased difficulty with urination.
ProVIDE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with an enlarged prostate.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had procedures done on my prostate.
Select...
I have not had urinary stones or blood in my urine in the last 3 months.
Select...
I have had prostate or bladder cancer.
Select...
I have taken medication to help with urination, like Proscar, Avodart, or Jalyn.
ProVIDE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ procedure - 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~procedure - 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Placebos
Effectiveness: Symptoms Improvement
Safety: Device or Procedure Related Serious Adverse Events
+1 moreProVIDE Trial Design
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Crossover ProVee Urethral Expander SystemExperimental Treatment1 Intervention
All subjects shall be unblinded following the 3 month follow-up visit. Those subjects randomized to the Sham Arm will be given the opportunity to "crossover" to the ProVee Urethral Expander System.
Group II: Device: The ProVee Urethral Expander SystemActive Control1 Intervention
The ProVee Urethral Expander System consists of two components: a nitinol Expander implant and a 19Fr Delivery System designed to allow the Expander to be deployed under direct vision for the treatment arm.
Group III: Sham: Ureteroscope and urethral access sheathPlacebo Group1 Intervention
An ureteroscope housed within the inner lumen of an urethral access sheath will be used under direct vision for the Sham procedure.
Find a Location
Who is running the clinical trial?
ProVerum MedicalLead Sponsor
2 Previous Clinical Trials
50 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have taken medication to help with urination, like Proscar, Avodart, or Jalyn.I have been diagnosed with an enlarged prostate.I have not had any procedures done on my prostate.I have tried and cannot tolerate medication for urinary symptoms, or I choose not to take them.The length of a specific part of your prostate called the prostatic urethra is longer than 3.75cm, as measured by a special ultrasound exam called TRUS.I have not had urinary stones or blood in my urine in the last 3 months.I have not taken drugs like Proscar, Avodart, or Jalyn to help with urination.I have had procedures done on my prostate.I have not had urinary stones or blood in my urine in the last 3 months.I have had prostate or bladder cancer.I have not had prostate or bladder cancer.Do you live full-time in the zip code that you provided?You have a score of 13 or higher on a test called IPSS or a score greater than 1 on a specific part of the test called IPSS V/S at the beginning of the study.My prostate size is between 30 cc and 80 cc.
Research Study Groups:
This trial has the following groups:- Group 1: Crossover ProVee Urethral Expander System
- Group 2: Device: The ProVee Urethral Expander System
- Group 3: Sham: Ureteroscope and urethral access sheath
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Benign Prostatic Hyperplasia Patient Testimony for trial: Trial Name: NCT05186740 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the cap on enrollment for this medical experiment?
"Indeed, the information that is posted on clinicaltrials.gov indicates that this trial has resumed its recruitment process. This study was first published on June 9th 2022 and most recent updated on July 25th 2022; thus far, 225 patients have been enrolled from two medical sites."
Answered by AI
Is enrollment still open for this research initiative?
"According to information found on clinicaltrials.gov, enrollment for this trial is ongoing and the investigation was launched on June 9th 2022 with a subsequent update being released in July 25th of that year."
Answered by AI
Who else is applying?
What state do they live in?
California
Other
Nevada
Florida
How old are they?
65+
What site did they apply to?
Other
Urology Austin
Sheldon Freedman MD
Avant Concierge Urology
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
2
1
0
What questions have other patients asked about this trial?
What’s it s details? is it trans urethral? How quickly can we start? when will i be contacted?
PatientReceived 2+ prior treatments
Is this similar to urolift?
PatientReceived 1 prior treatment
Why did patients apply to this trial?
Hopeful for a solution. I like to help science. I don’t take medications. Finestrride doesn’t help.
PatientReceived 1 prior treatment
natural way to get it up.
PatientReceived 2+ prior treatments
How responsive is this trial?
Most responsive sites:
- Sheldon Freedman MD: < 24 hours
- Avant Concierge Urology: < 24 hours
Typically responds via
Email
Phone Call
Average response time
- < 2 Days
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