Actively Recruiting
Laser Ablation a Salvage Treatment for Obstructive Benign Prostatic Hyperplasia
Led by The Cleveland Clinic · Updated on 2026-02-05
20
Participants Needed
1
Research Sites
85 weeks
Total Duration
On this page
Sponsors
T
The Cleveland Clinic
Lead Sponsor
R
Rocamed Inc
Collaborating Sponsor
AI-Summary
What this Trial Is About
Benign prostatic hyperplasia (BPH) is a common condition affecting aging men, often leading to lower urinary tract symptoms (LUTS). While Minimally Invasive Surgical Therapies (MIST) procedures offer less invasive alternatives to traditional surgery, some patients experience symptom recurrence or require further intervention due to lack of adequate relief of obstruction. Treatment of persistent obstruction after MIST therapy (BPH salvage therapy) typically requires surgical intervention like transurethral resection of prostate (TURP). This study proposes to evaluate the effectiveness of in-office transperineal laser ablation (TPLA) using the Echolaser system as a minimally invasive treatment option for these patients, potentially avoiding more invasive surgical procedures. The Cleveland Clinic sees a high volume of BPH salvage patients, making this an ideal setting for this research.
CONDITIONS
Official Title
Laser Ablation a Salvage Treatment for Obstructive Benign Prostatic Hyperplasia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male aged 40 years or older
- History of minimally invasive BPH procedure within the last 5 years
- International Prostate Symptom Score (IPSS) of 12 or higher
- Prostate volume between 30 and 80 grams as measured by CT, MRI, or ultrasound
- Prostate-specific antigen (PSA) less than 4, or if PSA is 4 to 10, evaluation to exclude prostate cancer by biopsy, MRI, biomarker, or surgeon judgment within 1 year
- Post-void residual urine volume greater than 150 cc or reduced urinary flow likely due to obstruction
- International Index of Erectile Function (IIEF-6) score of 10 or higher without medication
You will not qualify if you...
- Presence of an indwelling catheter or intermittent catheterization
- History of urethral strictures
- Previous diagnosis of prostate cancer
- Active urinary tract infection or prostatitis
- Hypoactive detrusor muscle function
- Neurogenic bladder caused by stroke, multiple sclerosis, Parkinson's disease, or spinal cord injury
- Ejaculatory dysfunction such as retrograde ejaculation, anorgasmia, or anejaculation
- Prior traditional BPH surgery such as TURP, PVP, Aquablation, HOLEP, or SP
- Presence of an obstructive median lobe of the prostate
- Moderate to severe erectile dysfunction based on IIEF-6 or SHIM scores
- Peyronie's disease
AI-Screening
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Trial Site Locations
Total: 1 location
1
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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