3-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/Actively Recruiting
Led by The Cleveland Clinic · Updated on 2026-02-05
20
Participants Needed
1
Research Sites
52 weeks
Total Duration
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
Laser Ablation a Salvage Treatment for Obstructive Benign Prostatic Hyperplasia
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The Cleveland Clinic
Lead Sponsor
Rocamed Inc
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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)
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)
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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https://pubmed.ncbi.nlm.nih.gov/36902647/The Cleveland Clinic
Lead Sponsor
Rocamed Inc
Collaborating Sponsor