Office Based Transperineal Laser Ablation for Benign Prostatic Hyperplasia HYPERPLASIA
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|ClinicalTrials.gov Identifier: NCT04760483|
Recruitment Status : Recruiting
First Posted : February 18, 2021
Last Update Posted : February 18, 2021
This study is set up as a phase I-II prospective, single center, interventional pilot study carried in Office setting under local anesthesia. 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 with benign prostatic hypertrophy (BPH).
BPH is currently managed with medications (ie, alpha-1 adrenergic medications) and/or invasive approaches such as transurethral resection of prostate or surgical excision of prostate - robotic or open lead to relaxation or excision of the bladder neck. Such alteration of the bladder neck function or anatomy portends a significant and noticeable change on a male lifestyle, represented by absence of antegrade ejaculation among others. This study aims to evaluate the use of TPLA in the office setting under local anesthesia - greatly decreasing patient perioperative surgical risk. Moreover, it aims to determine safety profile and outcomes from TPLA therapy
The fundamental objective is to determine the feasibility and safety of TPLA in healthy men with LUTS due to BPH, successful performed in the outpatient office-based setting under local anesthesia. Secondary objectives include: 1-Uroflowmetry and Patient Reported Outcome Measures (PROMs) at three, six and 12 months; 2-Immediately spontaneous voiding post-TPLA; 3-Hematuria incidence after TPLA, measured by patient reporting; 4-LUTS after the treatment measured by IPSS; 5- Erectile function and presence of ejaculation after TPLA treatment and 6-Prostate volume changes using Transrectal ultrasound (TRUS) volume measurements
|Condition or disease||Intervention/treatment||Phase|
|Male Urogenital Diseases Genital Diseases, Male Prostatic Disease Prostatic Hyperplasia||Device: SoracteLite(TM) TPLA for BPH||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single arm study using intervention performed with Echolaser X4 that will be offered to men between 40 and 85 years of age, with moderate or severe international prostate symptoms scores and concomitant objective decrease in flow studies of at 30% consistent with bladder outlet obstruction|
|Masking:||None (Open Label)|
|Official Title:||Soractelite(Tm) Transperineal Laser Ablation for Benign Prostatic Hyperplasia With Bladder Outlet Obstruction|
|Actual Study Start Date :||November 20, 2020|
|Estimated Primary Completion Date :||May 31, 2022|
|Estimated Study Completion Date :||November 20, 2022|
Experimental: Transperineal Laser Ablation for BPH
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.
Device: SoracteLite(TM) TPLA for BPH
see prior section
Other Name: Laser ablation of prostate tissues
- TREATMENT FEASBILITY IN OFFICE SETTING OF TPLA FOR BPH [ Time Frame: Under 30 minutes ]Completion of treatment intent, will evaluate if any procedure ought to be aborted, will measure pain using a visual analog scales. Watts scalation during treatment will be tested
- EFFICACY OF TPLA FOR BPH [ Time Frame: 4 weeks and up to 1 year ]Efficacy is measured by improvement in subjective (ie- IPSS min 1 max 35) and objective (ie flow studies) outcome measures. Patient reported outcomes
- Hematuria, Hematospermia [ Time Frame: 1 day and up to 1 year post intervention ]Presence, absence and duration
- SPONTANEUS VOIDING FOLLOWING TPLA FOR BPH [ Time Frame: Up to 1 week ]Trial of void before patient is discharged. If fails a repeat voiding trial would be conducted within next 48 hours and if there is failure at 1 week.
- Erections and Ejaculation [ Time Frame: 4 weeks and up to 1 year ]Using SHIM scale min 1 max 25. Ability to have and sustain erections without any help or with help with a PDE5 inhibitor. Presence or absence of ejalucation
- SAFETY PROFILE OF TPLA FOR BPH [ Time Frame: Up to 4 weeks ]Safety is assessed by device and procedural adverse events using the CTCAE v5.0 within the first 30 days. SoracteLite(TM) TPLA is safe when ≤10% of patients experience major adverse events, defined as grade 3 or higher.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04760483
|Contact: Fernando J Bianco, MDemail@example.com|
|Contact: Cielo D Guerrafirstname.lastname@example.org|