ProVee Urethral Expander System for Benign Prostatic Hyperplasia
(ProVIDE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing a new device called the ProVee Urethral Expander System. It aims to help men who have trouble urinating because of an enlarged prostate. The device works by widening the urethra, making it easier for urine to pass through.
Will I have to stop taking my current medications?
Yes, you may need to stop taking certain medications before joining the trial. The trial requires stopping some medications like alpha-blockers, 5-alpha-reductase inhibitors, and certain others within specific timeframes before the study begins.
Is the ProVee Urethral Expander System safe for humans?
How is the ProVee Urethral Expander System treatment different from other treatments for benign prostatic hyperplasia?
The ProVee Urethral Expander System is unique because it is designed to physically expand and reshape the prostatic urethra, which is different from other treatments that may involve medication or surgical procedures. This approach aims to relieve urinary symptoms by directly addressing the physical constriction caused by an enlarged prostate.14678
What data supports the effectiveness of the ProVee Urethral Expander System treatment for benign prostatic hyperplasia?
The ProVee Urethral Expander System is similar to the Prostatic Urethral Lift (PUL), which has shown positive results in treating lower urinary tract symptoms due to benign prostatic hyperplasia (BPH) in several studies. These studies reported improvements in symptoms and quality of life over three to five years, suggesting that similar treatments can be effective for BPH.79101112
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the ProVee Urethral Expander System or undergo a sham procedure
Follow-up
Participants are monitored for safety and effectiveness after treatment
Crossover
Subjects in the Sham Arm are given the opportunity to crossover to the ProVee Urethral Expander System after the 3-month follow-up
What Are the Treatments Tested in This Trial?
Interventions
- ProVee Urethral Expander System
Find a Clinic Near You
Who Is Running the Clinical Trial?
ProVerum Medical
Lead Sponsor