About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Indwelling catheter or intermittent catheterization
History of urethral strictures
Previous diagnosis of Prostate cancer
Active UTI or prostatitis
Trial population
Benign Prostatic Hyperplasia (BPH) salvage therapy patients
Trial design
Cohort
Prospective
Treatments tested in this trial
Transperineal Laser Ablation (TPLA)
Procedure/SurgeryOutpatient treatment with Transperineal Laser Ablation (TPLA) as a salvage therapy after previous Minimally Invasive Surgical Therapies (MIST)
Treatment groups
Trial outcomes
Primary outcomes
Evaluate the impact of in-office TPLA on voiding function in patients with recurrent BPH after prior MIST procedures
Change in Urinary Function as measured with IPSS score, Uroflow variables (Qmax) and Post void residue (PVR)
Secondary outcomes
Evaluate the effect of TPLA on erectile function & ejaculatory functions in this patient population
Change in Sexual function as measured by IIEF 6, MSHQ-EjD
Sponsors and contacts
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The Cleveland Clinic
Lead sponsor
Rocamed Inc
Collaborator