Transperineal laser ablation (TPLA) of the prostate for benign prostatic obstruction: the first 100 patients cohort of a prospective, single-center study.

PURPOSE: Transperineal laser ablation (TPLA) is a new minimally-invasive surgical treatment for patients with benign prostatic obstruction (BPO). We report the perioperative and mid-term functional results of the first 100 consecutively patients undergoing TPLA at our institution. METHODS: Clinical data from consecutive patients undergoing TPLA at our institution from April 2021 to July 2023 were prospectively collected. Primary endpoints were the postoperative changes in IPSS, QoL and MSHQ 3-item questionnaires and in Qmax and post-void residual volume (PVR). RESULTS: Overall, 100 consecutive patients underwent the procedure. Median age and prostate volume were 66 (IQR 60-75) years and 50 (IQR 40-70) ml, respectively. In the cohort, 14 (14%) patients had an indwelling catheter and 81 (81%) were under oral BPO therapy at the time of TPLA. Baseline median Qmax (ml/s) and PVR (ml) were 9.1 (IQR 6.9-12) and 90 (IQR 50-150), respectively, while median IPSS and QoL were 18 (IQR 15-23) and 4 (IQR 3-4). At all the follow-up timepoints, the evaluated outcomes on both symptoms and functional parameters showed a statistically significant improvement (p < 0.001). Antegrade ejaculation was preserved in all sexually active patients. No postoperative Clavien-Dindo > 2 complications were recorded. CONCLUSIONS: TPLA represents a safe option for selected well-informed patients swith LUTS due to BPO. Our prospective study confirms the feasibility and favorable perioperative and functional outcomes in a real-world cohort with heterogenous prostate volumes and patient characteristics.

Transperineal laser ablation of the prostate as a treatment for benign prostatic hyperplasia and prostate cancer: The results of a Delphi consensus project.

Objective: To evaluate transperineal laser ablation (TPLA) with Echolaser® (Echolaser® TPLA, Elesta S.p.A., Calenzano, Italy) as a treatment for benign prostatic hyperplasia (BPH) and prostate cancer (PCa) using the Delphi consensus method. Methods: Italian and international experts on BPH and PCa participated in a collaborative consensus project. During two rounds, they expressed their opinions on Echolaser® TPLA for the treatment of BPH and PCa answering online questionnaires on indications, methodology, and potential complications of this technology. Level of agreement or disagreement to reach consensus was set at 75%. If the consensus was not achieved, questions were modified after each round. A final round was performed during an online meeting, in which results were discussed and finalized. Results: Thirty-two out of forty invited experts participated and consensus was reached on all topics. Agreement was achieved on recommending Echolaser® TPLA as a treatment of BPH in patients with ample range of prostate volume, from <40 mL (80%) to >80 mL (80%), comorbidities (100%), antiplatelet or anticoagulant treatment (96%), indwelling catheter (77%), and strong will of preserving ejaculatory function (100%). Majority of respondents agreed that Echolaser® TPLA is a potential option for the treatment of localized PCa (78%) and recommended it for low-risk PCa (90%). During the final round, experts concluded that it can be used for intermediate-risk PCa and it should be proposed as an effective alternative to radical prostatectomy for patients with strong will of avoiding urinary incontinence and sexual dysfunction. Almost all participants agreed that the transperineal approach of this organ-sparing technique is safer than transrectal and transurethral approaches typical of other techniques (97% of agreement among experts). Pre-procedural assessment, technical aspects, post-procedural catheterization, pharmacological therapy, and expected outcomes were discussed, leading to statements and recommendations. Conclusion: Echolaser® TPLA is a safe and effective procedure that treats BPH and localized PCa with satisfactory functional and sexual outcomes.

Transperineal Laser Ablation (TPLA) Treatment of Focal Low-Intermediate Risk Prostate Cancer.

Background: This interventional pilot study aimed to evaluate the short-term (3 years) efficacy of focal laser ablation (FLA) in treating the index lesion of low-intermediate-risk prostate cancer, along with assessing the safety of the procedure (ClinicalTrials.gov ID NCT04045756). Methods: Forty patients aged between 46 and 86 with histologically proven organ-confined prostate cancer and low-to-intermediate progression risk were included. FLA was performed under percutaneous fusion magnetic resonance/ultrasound guidance in a Day Hospital setting under local anesthesia. Patients underwent regular clinical and functional assessments through the international index of erectile function (IIEF-5) and the International Prostatism Symptom Score (IPSS), PSA measurements, post-procedure MRI scans, and biopsies at 36 months or if positive findings were detected earlier. Statistical analyses were conducted to assess trends in PSA levels and cavity dimensions over time. Results: Forty patients were initially included, with fifteen lost to follow-up. At 36 months, a mean PSA reduction of 60% was observed, and 80% of MRI scans showed no signs of in-field clinically significant residual/recurrent cancer. Biopsies at 36 months revealed no malignant findings in 20 patients. No deterioration in sexual function or urinary symptoms was recorded. Conclusions: FLA appears to be safe, feasible, and effective in the index lesion treatment of low-intermediate-risk prostate cancer, with a high rate of tumor eradication and preservation of quality of life.

Transperineal laser ablation as treatment for benign prostatic obstruction: Safety, feasibility and functional outcomes-A pilot study.

Background: Standard surgical treatment for lower urinary tract symptoms (LUTS) due to benign prostatic obstruction (BPO) requires anaesthesia and hospitalization. Transperineal laser ablation (TPLA) is a novel minimally invasive treatment for BPO, which has been performed using local anaesthetics and conscious sedation. Objectives: The aim of this study is to assess safety, feasibility and functional outcomes of TPLA for the treatment of LUTS in men fit also for standard surgery. Methods: This prospective, multicentre, interventional pilot study included 20 patients. Eligible patients were men ≥40 years of age, with urodynamically proven bladder outlet obstruction, a peak urinary flow of 5-15 mL/s and a prostate volume of 30-120 cc. All subjects underwent Soractelite™ TPLA using the Echolaser® X4 system. Two to four fibres were placed in the prostate, whereafter laser light induced coagulative necrosis. Twelve months of follow-up included uroflowmetry, an ultrasound of the prostate and PROMs (IPSS and IIEF). Results: Twenty patients were treated with TPLA using local anaesthetics and optional sedation. Sixteen patients were treated in an outpatient setting, using only local anaesthetics in 12 of them; four were treated in the operating room, whereof two under general anaesthesia. No device related adverse events occurred, nor did any grade ≥3 adverse events during follow-up. Post-TPLA, 10 men continued spontaneous voiding, and 10 men developed a urinary retention treated by a temporary indwelling catheter for 15.2 ± 3.5 days. At 12 months, Qmax improved from 9.7 ± 3.5 to 14.9 ± 6.0 (p = 0.015), IPSS improved from 21.3 ± 5.2 to 10.9 ± 5.5 (p < 0.0001), QoL improved from 4.9 ± 0.9 to 1.9 ± 1.1 (p < 0.0001), IIEF-15 total score remained stable and 11/13 patients (85%) preserved antegrade ejaculation. Conclusions: TPLA is a safe and feasible treatment for men with LUTS due to BPO. TPLA can be performed in an outpatient setting under only local anaesthetics. Functional and quality of life outcomes improved significantly at 12 months, and erectile function remained stable.

Minimally invasive techniques in quest of Holy Grail of surgical management of enlarged prostates: a narrative review.

PURPOSE: Past decade has seen a renewed interest in minimally invasive surgical techniques (MISTs) for management of enlarged prostate. This narrative review aims to explore newer MIST for benign prostatic hyperplasia (BPH) which are not yet integrated into established societal guidelines. METHODS: We conducted a literature search across PubMed, Google Scholar, and FDA ClinicalTrials.gov databases on June 1st, 2023, to identify studies published within the past decade exploring various MISTs for BPH. Additionally, we gathered insights from abstracts presented in meetings of professional associations and corporate websites. We broadly classified these procedures into three distinct categories: energy-based, balloon dilation, and implant/stent treatments. We collected detail information about the device, procedure details, its inclusion and exclusion criteria, and outcome. RESULTS: Our review reveals that newer energy-based MISTs include Transperineal Laser Ablation, Transurethral Ultrasound Ablation, and High-Intensity Focused Ultrasound. In the sphere of balloon dilation, Transurethral Columnar Balloon Dilation and the Optilume BPH Catheter System were gaining momentum. The noteworthy implants/stents that are on horizon include Butterfly Prostatic Retraction Device, Urocross Expander System, Zenflow Spring System, and ProVee Urethral Expander System. CONCLUSION: The exploration of various MISTs reflects ongoing efforts to enhance patient care and address limitations of existing treatments. This review provides a bird-eye view and valuable insights for urologists and researchers seeking to navigate the dynamic landscape of MISTs in the quest for effective and minimally invasive solutions for enlarged prostates.

Transurethral resection of the prostate (TURP) versus transperineal laser ablation (TPLA) due to benign prostatic hyperplasia (BPH): prospective and comparative study.

AIM: We aimed to compare the first-year results of Transurethral resection of the prostate (TURP), the gold standard method, and Transperineal laser ablation (TPLA) techniques. MATERIAL AND METHODS: This study was designed as a prospective, randomized, controlled, and single-center and was conducted between November 2021 and February 2023. TURP candidates were included in the study. Demographic data and perioperative data were recorded. Preoperative and first-year International Prostate Symptom Score (IPSS), International Erectile Function Index (IIEF-5), Male Sexual Health Questionnaire-Ejaculatory Dysfunction (MSHQ-EjD), QoL, peak urinary flow rate (Qmax), prostate volume (PV) and postvoid residual (PVR) data were recorded. RESULTS: Fifty patients were included in the study and were assigned to equal numbers of groups. TPLA group had a higher ASA score (p = 0.03). There was improvement in IPSS, Qmax, and PVR parameters compared to baseline values in both groups at 1 year (p < 0.01). The improvement in Qmax was better in the TURP group (p < 0.01). IIEF-5 score was similar between groups (p = 0.83 and p = 0.12, respectively). The MSHQ scores in the first year did not change according to their baseline values in the TPLA group (p = 0.54 and p = 0.34, respectively). CONCLUSION: According to the first-year results of TPLA, the symptomatic improvement effect without sacrificing ejaculatory functions is comparable to TURP. We think that this method will can be an alternative, especially for patients who want to avoid ejaculatory dysfunction, who have a high risk of anesthesia, and whose anticoagulant/antiplatelet therapy cannot be discontinued.

Ultrasound-guided SoracteLite™ transperineal laser ablation (TPLA) of the prostate for the treatment of symptomatic benign prostatic hyperplasia (BPH): a prospective single-center experience.

PURPOSE: To evaluate the efficacy and safety of ultrasound-guided transperineal laser ablation (TPLA) in patients with symptomatic BPH. MATERIALS AND METHODS: From January 2020 to January 2022, 63 prospectively enrolled patients underwent TPLA with a 1064-nm continuous-wave diode laser (EchoLaser, Elesta SpA). Primary endpoints were the change in IPSS, QoL, Qmax, PVR and prostate volume at 3 and 12 months. RESULTS: At 3 months, IPSS improved from 20.8 ± 7.4 to 11.0 ± 6.6 (p < 0.001), QoL from 4.7 ± 1.4 to 1.5 ± 1.2 (p < 0.001) and Qmax from 8.6 ± 3.5 mL/s to 13.2 ± 5.7 mL/s (p = 0.083). PVR decreased from 124.8 ± 115.4 mL to 43.6 ± 53.6 mL (p < 0.001), and prostate volume decreased from 63.6 ± 29.7 mL to 45.6 ± 21.8 mL (p = 0.003). At 12 months, IPSS 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), and Qmax from 8.6 ± 3.5 mL/s to 16.2 ± 4.3 mL/s (p = 0.014). PVR decreased from 124.8 ± 115.4 mL to 40.6 ± 53.6 mL (p = 0.003), and prostate volume decreased from 63.6 ± 29.7 mL to 42.8 ± 14.2 mL (p = 0.071). Transient complications consisted of two patients with prostatic abscess (Clavien-Dindo grade IIIa) and one patient with orchitis (Clavien-Dindo grade II). CONCLUSIONS: TPLA for symptomatic BPH provides clinical benefits at 3 and 12 months, and the treatment is well tolerated.

Transperineal Laser Ablation of the Prostate (TPLA) for Lower Urinary Tract Symptoms Due to Benign Prostatic Obstruction.

We aimed to review the current evidence on surgical and functional outcomes of Transperineal Laser Ablation for LUTS due to BPH. A comprehensive review of the English-language literature was performed using the MEDLINE and Web of Science databases until 1 August 2022, aiming to select studies evaluating TPLA for the treatment of LUTS due to BPH. Additional records were found from Google Scholar. Data were extracted and summarized in Tables. An appropriate form was used for qualitative data synthesis. Seven studies were included in the review, with all being single arm, non-comparative studies. In all studies, functional outcomes were evaluated with uroflowmetry parameters and validated questionnaires, showing a promising effectiveness at short- and mid-term follow-up. There is a lack of standardized pathways for preoperative assessment of patients suitable for TPLA, and even the technique itself has been reported with a few nuances. A good safety profile has been reported by all the authors. Although promising results have been reported by different groups, selection criteria for TPLA and few technical nuances regarding the procedure were found to be heterogeneous across the published series that should be standardized in the future. Further research is needed to confirm these findings.

Transperineal interstitial laser ablation of the prostate, a novel option for minimally invasive treatment of benign prostatic obstruction.

BACKGROUND: In the algorithm of treatment of benign prostatic obstruction (BPO), the shift from medical therapy to surgery is steep in terms of invasiveness. Recently, a lively interest has developed on alternative micro-invasive options. Transperineal interstitial laser ablation (TPLA) was recently proposed for BPO treatment. OBJECTIVE: This work aims to illustrate feasibility, efficacy and safety profile of TPLA in BPO treatment. DESIGN, SETTING, AND PARTICIPANTS: We prospectively analyzed the results of TPLA performed between September 2018 and March 2019 for LUTS due to BPO, in men with prostate volume <100 ml. SURGICAL PROCEDURE: TPLA was performed in OR, under local anesthesia, using Soracte Lite-EchoLaserX4. Diode laser light is conveyed through 300 µm optical fibers introduced transperineally by 21 Ga needles and placed at a security distance from urethra and bladder neck. EchoLaser Smart Interface eases needle positioning and increases the safety. MEASUREMENTS: The primary endpoint was the variation of Qmax and IPSS at 1, 3 and 6 months. We also assessed the ejaculatory function and recorded complications. These outcomes were further investigated at 12 months by phone call. RESULTS AND LIMITATIONS: 21 men with prostate volume of 43.5 ± 8.5 ml underwent TPLA. All were discharged after 24 h, keeping the transurethral catheter for 8.7 ± 2.5d. At one month all patients but one discontinued medical therapy, showing significant advantage in Qmax (+3.4 ± 5.7 ml/s; p < 0.01) and IPSS (-5.6 ± 7.0; p < 0.01). Functional results were still progressing at 6 months, with Qmax (+4.7 ± 6.0 ml/s; p < 0.01) and IPSS improvement (-13.1 ± 4.7; p < 0.01). The ejaculatory function was preserved as the MSHQ-EjD increased (p < 0.05). The only complication was a prostatic abscess, treated with transperineal drainage and antibiotic. CONCLUSIONS: TPLA is a micro-invasive treatment for BPO showing good functional and safety outcomes. PATIENT SUMMARY: This work illustrates the results of TPLA to treat LUTS due to BPO, showing high efficacy, preservation of the ejaculation, and low complication rate.

Dynamic prostatic and laser-ablated lesion volume change after transperineal laser ablation in canine: preliminary observation and its clinical significance.

AIM: The purpose of this study is to observe the volume change of prostate and laser-ablated lesions in the canine and to explore the mechanism and clinical significance through histopathology. MATERIALS AND METHODS: Transperineal laser ablation (TPLA) was performed under the guidance of transrectal ultrasound (TRUS) in eight canines. Two canines were sacrificed 1 day and 1 week after TPLA, respectively. The remaining six canines were sacrificed after finishing transrectal contrast-enhanced ultrasound (TR-CEUS) at three phases. RESULTS: The prostatic volumes immediately following TPLA and 1 week later were larger than before TPLA (20.1 ± 3.9 vs 17.1 ± 3.8 ml; 21.7 ± 3.6 vs 17.1 ± 3.8 ml, p < 0.05), but 1 month later, returned to the preoperative level (17.4 ± 3.2 ml). At three time points, the mean volumes of laser-ablated lesions at 3 W/600 J were 0.6 ± 0.2, 1.1 ± 0.4, and 1.7 ± 0.5 ml, respectively, while those of laser-ablated lesions at 3 W/1200 J were 1.2 ± 0.2, 1.6 ± 0.3, and 2.2 ± 0.5 ml, respectively. The mean volumes of laser-ablated lesions increased significantly over time after TPLA (p < 0.050). CONCLUSION: The prostate volume transient enlarges after TPLA, which prompts for clinical application that it should prolong appropriately the duration of urinary catheterization to avoid acute urinary retention. Many inflammatory cells were observed in the laser-ablated lesions and adjacent normal prostate parenchyma through histopathology. It is speculated that the inflammatory response is involved in the progression of tissue damage.

Transperineal Laser Ablation Treatment for Lower Urinary Tract Symptoms Due to Benign Prostatic Obstruction: Protocol for a Prospective In Vivo Pilot Study.

BACKGROUND: Standard surgical treatments for lower urinary tract symptoms (LUTS) due to benign prostatic obstruction (BPO) use a transurethral approach. Drawbacks are the need for general or spinal anesthesia and complications such as hematuria, strictures, and cloth retention. Therefore, a minimal invasive technique under local anesthesia is desired to improve patient safety. Recently, SoracteLite transperineal laser ablation (TPLA) has been introduced as a novel minimal invasive treatment for BPO. The system used is unique because 4 laser sources are independently available. This 1064-nm diode laser induces coagulative necrosis. Moreover, TPLA is unique because it has a transperineal approach and can be performed under local anesthesia in an outpatient setting. OBJECTIVE: The primary objective of this study is to determine the safety and feasibility of TPLA treatment for men, who are fit for standard surgery, with LUTS due to BPO. The secondary objectives are to determine functional outcomes by flowmetry and patient-reported outcome measures (PROMs), side effects, and tissue changes observed on imaging. METHODS: This study is a prospective, single center, interventional pilot study IDEAL framework stage 2a and will include 20 patients. Eligible patients are men ≥40 years of age, with a prostate volume of 30 to 120 cc, have urodynamically proven bladder outlet obstruction, and have a peak urinary flow of 5 to 15 mL per second. All patients will undergo TPLA of their prostate under local anesthesia by using the EchoLaser system. Depending on the prostate volume, 2 to 4 laser fibers will be placed bilaterally into the prostate. Patient follow-up consists of uroflowmetry, PROMs, and imaging by using contrast-enhanced ultrasound. Total follow-up is 12 months following treatment. RESULTS: Presently, recruitment of patients is ongoing. Publication of first results is expected by early 2020. CONCLUSIONS: TPLA offers the potential to be a novel minimal invasive technique for treatment of LUTS due to BPO in men fit for standard desobstruction. This study will evaluate the safety and feasibility of TPLA and report on functional outcomes and tissue changes observed on imaging following TPLA treatment. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/15687.