Laser Ablation a Salvage Treatment for Obstructive Benign Prostatic Hyperplasia

Recruiting now

Conditions studied: Benign Prostatic Hyperplasia (BPH)

In brief

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.

Key facts

Study ID

NCT07016620

Run by

The Cleveland Clinic

People needed

20

Starts

2026-01-12

Expected to finish

2027-09-01

Last updated by the study team

2026-02-05

Who can join

Age: 40 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Men > 40 years old
• History of Minimally invasive BPH procedure within the last 5 years.
• IPSS >= 12
• Prostate Volume 30 - 80 gr as assessed by CT, MRI or TRUS.
• PSA <4 or for patients with PSA 4-10 evaluation has been performed to rule out prostate cancer using biopsy, MRI, biomarker, or surgeon judgement. Labs within 1 year of study initiation
• PVR > 150cc or reduced flow on uroflow likely due to obstruction based on clinical judgement
• IIEF-6>or =10 without medication

You may not qualify if…

• Indwelling catheter or intermittent catheterization
• History of urethral strictures
• Previous diagnosis of Prostate cancer
• Active UTI or prostatitis
• Hypoactive detrusor function
• Neurogenic bladder (secondary to stroke, Multiple Sclerosis, Parkinson's disease, Spinal cord injury)
• Ejaculatory dysfunction (retrograde ejaculation, anorgasmia or anejaculation)
• Prior traditional BPH surgery (TURP, PVP, Aquablation, HOLEP, SP)
• Presence of obstructive median lobe
• Moderate to severe or severe ED based on IIEF-6/SHIM (SHIM of 10)
• Peyronie's disease

Where it is running

• Cleveland Clinic — Cleveland, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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