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Laser Ablation a Salvage Treatment for Obstructive Benign Prostatic Hyperplasia

Recruitingn/aAges 40 Years - anyMaleThe Cleveland Clinic
NCT07016620 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Exclusion Criteria: * 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
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What it tests

  • Transperineal Laser Ablation (TPLA)
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Where

1 site
Cleveland Clinic
Cleveland, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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