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Tests treatment safety and results for Benign Prostatic Hyperplasia
Official title A Clinical Study to Evaluate the Safety and Efficacy of the FloStent in Men With Benign Prostatic Hyperplasia Symptoms
ClinicalTrials.gov ID: NCT06849258
What this study is testing
- What it's testing
- The goal of this study is to determine the safety and effectiveness of the FloStent, a medical device used to treat men with symptoms of Benign Prostatic Hyperplasia, compared to sham (procedure without deployment of the FloStent). All participants will undergo a flexible cystoscopy and those randomized to the treatment arm will receive the FloStent, while those randomized to the sham arm will not receive the FloStent.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 and older, men only
You may be able to join if
- Male people \> 45 years of age who have symptomatic BPH
- International Prostate Symptom Score (IPSS) score \>13
- Peak urinary flow rate (Qmax): \>5 mL/sec and \ 125 mL
- Post-void residual (PVR) \<250 mL
- Prostate volume 25 to 80 mL
You likely can't join if
- Presence of an artificial urinary sphincter or stent(s) in the urethra or prostate
- Prior minimally invasive intervention or surgical intervention of the prostate or urethra
- PSA \>10 ng/mL
- Bladder cancer or bladder stones
- Active urinary tract infection (UTI)
- Uncontrolled diabetes
See the full eligibility criteria
- Male people \> 45 years of age who have symptomatic BPH
- International Prostate Symptom Score (IPSS) score \>13
- Peak urinary flow rate (Qmax): \>5 mL/sec and \ 125 mL
- Post-void residual (PVR) \<250 mL
- Prostate volume 25 to 80 mL
- Prostatic urethral length 20-50 mm
- Able to complete the study protocol and visits
- Presence of an artificial urinary sphincter or stent(s) in the urethra or prostate
- Prior minimally invasive intervention or surgical intervention of the prostate or urethra
- PSA \>10 ng/mL
- Bladder cancer or bladder stones
- Active urinary tract infection (UTI)
- Uncontrolled diabetes
- Part of a vulnerable population (cognitively challenged or are incarcerated)
The study team makes the final eligibility decision.
Where it's taking place
- Bakersfield, California, United States
- Beverly Hills, California, United States
- La Mesa, California, United States
- Los Angeles, California, United States
- Montebello, California, United States
- Tustin, California, United States
- Littleton, Colorado, United States
- Daytona Beach, Florida, United States
- Lisle, Illinois, United States
- Lafayette, Louisiana, United States
- Troy, Michigan, United States
- Las Vegas, Nevada, United States
- New York, New York, United States
- Syosset, New York, United States
- Raleigh, North Carolina, United States
- Germantown, Tennessee, United States
- Austin, Texas, United States
- Houston, Texas, United States
- Wollongong, New South Wales, Australia
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 male, 45 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bakersfield, California, United States; Beverly Hills, California, United States; La Mesa, California, United States; Los Angeles, California, United States; Montebello, California, United States; Tustin, California, United States and 13 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.