Laser Ablation for Benign Prostatic Hyperplasia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new laser treatment, SoracteLite(TM) TPLA, for men with benign prostatic hyperplasia (BPH), a condition causing urinary problems. The goal is to determine if using a laser under local anesthesia can improve symptoms and quality of life without more invasive surgery. The study will assess any side effects and the treatment's effectiveness in a simple office setting. Men with noticeable urinary issues due to BPH who have not had previous prostate interventions might be suitable for this trial. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the chance to be among the first to receive this innovative therapy.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it mentions that you must be able to temporarily stop anticoagulation or anti-platelet therapy. It's best to discuss your specific medications with the trial team.
What prior data suggests that this laser ablation technique is safe for treating benign prostatic hyperplasia?
Research has shown that transperineal laser ablation (TPLA) is generally well-tolerated for treating an enlarged prostate, also known as benign prostatic hyperplasia (BPH). Studies indicate that TPLA improves symptoms at both 3 and 12 months after treatment. It is considered a safe and less invasive option for men with urinary problems caused by BPH.
Patients have reported positive results and few side effects, making it a promising alternative to more invasive surgeries. One study confirmed that TPLA is safe and practical when performed in an outpatient setting. Overall, the evidence suggests that TPLA is a reliable choice for managing BPH symptoms with a good safety record.12345Why are researchers excited about this trial?
Unlike the standard treatments for Benign Prostatic Hyperplasia (BPH), which often include medications like alpha-blockers and 5-alpha reductase inhibitors or surgical procedures, SoracteLite(TM) TPLA offers a minimally invasive approach using transperineal laser ablation. This technique targets the enlarged prostate tissue with precision, using laser fibers guided by advanced imaging, potentially reducing side effects and recovery time compared to traditional surgeries. Researchers are excited about this treatment because it could provide effective relief with a lower risk of complications, allowing patients to return to their daily lives more quickly.
What evidence suggests that transperineal laser ablation is effective for benign prostatic hyperplasia?
Research has shown that transperineal laser ablation (TPLA), the treatment under study in this trial, offers a promising approach for managing an enlarged prostate, also known as benign prostatic hyperplasia (BPH). One study found that patients experienced a significant reduction in symptoms, with symptom scores dropping from 20.8 to 8.4, indicating fewer symptoms and improved quality of life. Another study discovered that TPLA improved urine flow and reduced prostate size over a year. Additionally, TPLA has effectively treated both BPH and localized prostate cancer while preserving good sexual function. Overall, TPLA appears to be a safe and effective way to manage BPH symptoms.12356
Who Is on the Research Team?
FERNANDO J BIANCO, MD
Principal Investigator
Urlogical Research Network
Are You a Good Fit for This Trial?
Men aged 40-85 with benign prostatic hyperplasia (BPH) can join this trial. They must have certain urinary flow rates, a prostate size within specific limits, and moderate to severe lower urinary tract symptoms but no history of invasive prostate interventions or major neurological conditions. Participants need normal kidney function and the ability to stop blood thinners temporarily.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo SoracteLiteTM transperineal laser ablation (TPLA) for benign prostatic hyperplasia (BPH) under local anesthesia
Immediate Follow-up
Participants are monitored for immediate adverse events and recovery post-procedure
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments at 3, 6, and 12 months
Long-term Follow-up
Participants are monitored for long-term outcomes and potential re-treatment or conversion to other surgical management
What Are the Treatments Tested in This Trial?
Interventions
- SoracteLite(TM) TPLA for BPH
Trial Overview
The study is testing SoracteLite(TM) TPLA for BPH in an office setting under local anesthesia. It aims to improve quality of life by reducing risks associated with traditional surgical treatments for BPH while preserving sexual functions like ejaculation.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Ceftriaxone 250 mg IM as antibiotic prophylaxis. Local Anesthesia: perineal skin will be infiltrated with 10 cc of Lidocaine 2% and then each neurovascular bundle will be infiltrated with 5 - 10 cc. Nitrous self-administered anesthesia will be available. One or two laser fibers from Echolaser x4 will be placed in each of the two prostate lobes using the plan. Treatment will be executed following Echolaser smart Interface planning, needles will follow targeted location using stepper grid under a transperineal approach in a sagittal plane. Ablation with 5 watts power per fiber, a total of \~ 1800 J will be delivered. We will evaluate pain measures and procedure tolerance using visual analog pain scale Upon completion we will measure coagulation zone with TRUS. Before discharge, trial of void will be conducted. Patients with a residual greater than 200 cc will have an indwelling catheter placed and will be discharged with it.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Urological Research Network, LLC
Lead Sponsor
Citations
Ultrasound-guided SoracteLite™ transperineal laser ...
At 12-month follow-up, IPSS was significantly improved from 20.8 ± 7.4 to 8.4 ± 5.9 (p < 0.001), QoL from 4.7 ± 1.4 to 1.2 ± 0.8 (p < 0.001), ...
Real-World Clinical Outcomes of Transperineal Laser ...
We observed significant and progressive improvements in IPSS, Qmax, PVR, and prostate volume over a 12-month follow-up. Additionally, ...
Transperineal laser ablation of the prostate as a treatment ...
Conclusion. Echolaser® TPLA is a safe and effective procedure that treats BPH and localized PCa with satisfactory functional and sexual outcomes.
Office Based Transperineal Laser Ablation for Benign ...
It will assess the impact in quality of life and adverse events produced by transperineal laser ablation of the prostate (TPLA) in men 40 to 85 years of age ...
5.
bjui-journals.onlinelibrary.wiley.com
bjui-journals.onlinelibrary.wiley.com/doi/full/10.1002/bco2.278Transperineal laser ablation as treatment for benign prostatic ...
Functional outcomes increased significantly, up to 50% at 12 months. TPLA adds a new technique to the landscape of minimally invasive treatments ...
Prostate Cancer Safety and Feasibility of Soractelite ...
TPLA for the treatment of PCa at the outpatient clinic appears to be safe and feasible with good short-term QoL and functional outcomes.
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