Laser Ablation a Salvage Treatment for Obstructive Benign Prostatic Hyperplasia
In-Office Transperineal Laser Ablation (TPLA) as a Salvage Treatment for Obstructive Benign Prostatic Hyperplasia (BPH) After Minimally Invasive Surgical Therapies (MIST)
The Cleveland Clinic
20 participants
Jan 12, 2026
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria7
- 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 Criteria11
- 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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Interventions
Outpatient treatment with Transperineal Laser Ablation (TPLA) as a salvage therapy after previous Minimally Invasive Surgical Therapies (MIST)
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07016620