Laser Ablation a Salvage Treatment for Obstructive Benign Prostatic Hyperplasia
Launched by THE CLEVELAND CLINIC · Jun 4, 2025
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new method called transperineal laser ablation (TPLA) to treat men who have persistent urinary problems caused by benign prostatic hyperplasia (BPH) after having other less invasive treatments. BPH is a common condition in older men that can make urination difficult and uncomfortable. The goal of this study is to see if TPLA can provide relief without needing more invasive surgeries, which can have longer recovery times.
To participate, men over 40 years old who have undergone a minimally invasive BPH treatment in the last five years may be eligible. They should also have certain urinary symptoms and specific prostate size as measured by imaging tests. Participants will receive the laser treatment in an office setting, which is designed to be less invasive. It's important to note that individuals with certain health issues or previous surgeries related to BPH may not be able to join this study. Overall, this trial aims to offer a promising alternative for men struggling with ongoing urinary issues after other treatments.
Gender
MALE
Eligibility criteria
- 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
About The Cleveland Clinic
The Cleveland Clinic is a renowned nonprofit academic medical center based in Cleveland, Ohio, recognized for its commitment to advancing healthcare through innovative research and clinical excellence. As a leading sponsor of clinical trials, the Cleveland Clinic leverages its multidisciplinary expertise and state-of-the-art facilities to conduct groundbreaking studies aimed at improving patient outcomes across a wide range of medical conditions. With a strong emphasis on patient-centered care, the institution fosters collaboration among researchers, clinicians, and patients to explore new treatments and therapies, contributing significantly to the global body of medical knowledge.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Cleveland, Ohio, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported