Transperineal Laser Ablation for Benign Prostatic Enlargement: A Systematic Review and Pooled Analysis of Pilot Studies.
Alessandro Tafuri, Andrea Panunzio, Francesco De Carlo...
https://pubmed.ncbi.nlm.nih.gov/36902647Actively Recruiting
Age: 40Years +
MALE
ID07016620
In-Office Transperineal Laser Ablation as Salvage Treatment for Obstructive Benign Prostatic Hyperplasia After Minimally Invasive Surgical Therapies
Led by The Cleveland Clinic · Updated on 2026-02-05
20
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
T
The Cleveland Clinic
Lead Sponsor
R
Rocamed Inc
Collaborating Sponsor
AI-Summary
What this Trial Is About
Benign prostatic hyperplasia (BPH) is a common condition affecting older men, often causing lower urinary tract symptoms (LUTS). This research focuses on evaluating in-office transperineal laser ablation (TPLA) using the Echolaser system as a minimally invasive treatment option for men who have persistent obstruction after failing previous minimally invasive surgical therapies (MIST). The study is conducted at the Cleveland Clinic, which treats many patients needing BPH salvage therapy, making it an ideal place for this investigation. The study involves outpatient treatment with TPLA as a salvage therapy for men with recurrent BPH after prior MIST procedures. This technique aims to improve urinary flow and reduce symptoms while potentially preserving sexual and ejaculatory function. Participants will receive TPLA and be monitored at baseline, and then at 1, 3, 6, and 12 months after treatment to assess changes. During the study, participants will undergo evaluations including assessments of urinary flow rate, post-void residual volume, symptom scores, and sexual function questionnaires. Researchers will track outcomes such as maximum urinary flow rate, residual urine volume, International Prostate Symptom Score (IPSS), and sexual health measures at multiple time points up to one year post-treatment. This will help determine the impact of TPLA on voiding and sexual function in this patient group.
CONDITIONS
Brief Title
Laser Ablation a Salvage Treatment for Obstructive Benign Prostatic Hyperplasia
Who Can Participate
Age: 40Years +
MALE
Eligibility Criteria
You may qualify if you...
- Men older than 40 years
- History of minimally invasive BPH procedure within the last 5 years
- International Prostate Symptom Score (IPSS) of 12 or higher
- Prostate volume between 30 and 80 grams as assessed by CT, MRI, or TRUS
- PSA less than 4 or if PSA is 4 to 10, evaluation to rule out prostate cancer has been performed
- Post-void residual volume greater than 150 cc or reduced urine flow likely due to obstruction
- International Index of Erectile Function (IIEF-6) score of 10 or higher without medication
You will not qualify if you...
- Use of an indwelling catheter or intermittent catheterization
- History of urethral strictures
- Previous diagnosis of prostate cancer
- Active urinary tract infection or prostatitis
- Hypoactive detrusor muscle function
- Neurogenic bladder caused by conditions like stroke, multiple sclerosis, Parkinson's disease, or spinal cord injury
- Ejaculatory dysfunction such as retrograde ejaculation, anorgasmia, or anejaculation
- Prior traditional BPH surgery such as TURP, PVP, Aquablation, HOLEP, or SP
- Presence of obstructive median lobe of the prostate
- Moderate to severe erectile dysfunction based on IIEF-6/SHIM score of 10
- Peyronie's disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Single treatment visit
Participants receive outpatient Transperineal Laser Ablation (TPLA) as a salvage therapy after previous Minimally Invasive Surgical Therapies (MIST).
1 visit (in-person)
Post-treatment Follow-up
Duration - 12 months post-treatment
Participants are monitored for improvements in urinary flow, symptom relief, and sexual function at multiple time points after treatment.
Visits at 1, 3, 6, and 12 months post-treatment (in-person)
Trial Site Locations
Total: 1 location
1
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
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How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
Transperineal interstitial laser ablation of the prostate, a novel option for minimally invasive treatment of benign prostatic obstruction.
Gaetano de Rienzo, Alfonso Lorusso, Paolo Minafra...
https://pubmed.ncbi.nlm.nih.gov/328681373-T MRI and clinical validation of ultrasound-guided transperineal laser ablation of benign prostatic hyperplasia.
Guglielmo Manenti, Tommaso Perretta, Antonello Calcagni...
https://pubmed.ncbi.nlm.nih.gov/34532768