Benign Prostatic Hyperplasia Clinical Trial
— PEAKOfficial title:
Safety and Effectiveness of the Optilume® BPH Catheter System in a Post-Market Study
Verified date | March 2024 |
Source | Urotronic Inc. |
Contact | Jill Moland |
Phone | 612-245-6434 |
jmoland[@]laborie.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The goal of this clinical trial is to verify the continued safety and effectiveness for the Optilume BPH Catheter System.
Status | Recruiting |
Enrollment | 92 |
Est. completion date | February 7, 2031 |
Est. primary completion date | February 7, 2031 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 50 Years and older |
Eligibility | Inclusion Criteria: 1. Male subject = 50 years old 2. Diagnosed with lower urinary tract symptoms (LUTS) secondary to obstructive benign prostatic hyperplasia (BPH) 3. Able to be treated with the Optilume BPH Catheter System in accordance with the Instructions for Use 4. Prostate volume < 80 g with a prostatic urethral length between 32-55 mm as determined by trans-rectal ultrasound (TRUS) 5. International Prostate Symptom Score (IPSS) = 13 6. Peak urinary flow rate (Qmax) 5-15 mL/sec with minimum voided volume of 125 mL 7. Willing to provide informed consent and comply with protocol required follow-up Exclusion Criteria: 1. Unwilling to abstain from sexual intercourse or use a condom for 30 days post-procedure and utilize a highly effective contraceptive for at least 12 months post-procedure 2. Presence of an artificial urinary sphincter, penile prosthesis, or stent(s) in the urethra or prostate 3. Any prior minimally invasive intervention (e.g., TUNA, Balloon, Microwave, Rezum, UroLift) or surgical intervention of the prostate 4. Confirmed or suspected malignancy of prostate or bladder. Negative prostate biopsy required within 6 months of enrollment if PSA at baseline is > 4 ng/mL with free PSA < 25%. 5. Active urinary tract infection (UTI) confirmed by culture 6. Neurogenic bladder or sphincter abnormalities or neurological disorders that might affect bladder or sphincter function 7. History of overt urinary incontinence requiring the use of pads 8. Previous or current diagnosis of urethral strictures, bladder neck contracture or detrusor muscle spasms 9. Current post-void residual volume (PVR) > 300 mL or catheter dependent bladder drainage 10. Known poor detrusor muscle function (e.g., Qmax < 5 mL/sec) 11. Active bladder, ureteral, or urethral stones or stone passage within the last 3 months 12. Current poorly controlled diabetes (i.e., hemoglobin A1c = 8%) 13. Anatomy (e.g., presence of false passage or size of meatus) is not suitable for treatment with the Optilume BPH Catheter System 14. Obstructive median lobe in the opinion of the investigator |
Country | Name | City | State |
---|---|---|---|
United States | Urotronic, INC | Plymouth | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Urotronic Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary efficacy endpoint is the average IPSS improvement from baseline to 12 months. | improvement of IPSS score | Baseline to 12 months | |
Secondary | Semen Sub-Study Safety Secondary Endpoint | The average change from baseline in sperm concentration at 13 weeks (3 months) post-procedure will be compared against a performance goal of -30% (30% decrease from baseline). | baseline to 3 months |
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