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    Appendix B: Other relevant studies

    Other potentially relevant studies that were not included in the main evidence summary (tables 2 and 3) are listed in table 5 below.

    Table 5 additional studies identified

    Study

    Number of people and follow up

    Direction of conclusions

    Reason study was not included in main evidence summary

    Busetto GM, Checchia A, Recchia M et al. (2023) Minimally invasive surgical therapies (MISTs) for lower urinary tract symptoms (LUTS): promise or panacea? Asian J Androl.26(2):135–43.

    Review

    MISTs are a new promise, and clinical trials with longer follow-up are lacking. Most of them are under investigation and, only a few options have been given as a recommendation for use. They cannot be considered as standard of care and are not suitable for all patients.

    Review

    Cai HJ, Fang JH, Kong FL, et al. Ultrasound-guided transperineal laser ablation for percutaneous treatment of benign prostatic hyperplasia: a new minimally invasive interventional therapy. Acta Radiol 2022; 63: 553–558

    Retrospective case series

    (single centre study)

    n=20 patients with BPH who had US-TPLA.

    Follow-up 6 months

    After 6 months, average IPSS improved from 22.7 to 9.1 (P < 0.001), the QoL improved from 4.9 to 2.3 (P < 0.001), the Qmax improved from 8.5 to 15.2 mL/s (P < 0.001), the PVR increased from 78.7 to 30.3 (P < 0.05), and the mean prostate volume ranged from 70.8 to 54.7 mL (P < 0.05).

    Study included in systematic review added to the summary of evidence.

    Cai H, Zhu C and Fang J. Ultrasound-guided perineal laser ablation versus prostatic arterial embolization for benign prostatic hyperplasia: two similar short-term efficacies. Acta Radiol 2022: 64: 2841851221140214.

    Retrospective comparative study

    n=40 patients with benign prostatic hyperplasia (BPH).

    n=20 had ultrasound-guided transperineal laser ablation (US-TPLA) and 20 had prostatic artery embolization (PAE).

    Follow-up 6 months.

    US-TPLA and PAE seem to have a similar short-term efficacy for BPH treatment. The efficacy of the two procedures is comparable, and neither is associated with serious complications.

    Study included in systematic review added to the summary of evidence.

    de Rienzo G, Lorusso A, Minafra P, et al. Transperineal interstitial laser ablation of the prostate, a novel option for minimally invasive treatment of benign prostatic obstruction. Eur Urol 2021; 80: 95–103

    Prospective case series

    n=21 patients with LUTS due to BPH, in people with prostate volume<100ml had TPLA.

    Follow-up 6 months (at 12 months phone calls)

    TPLA is a micro-invasive treatment for BPH showing good functional, preservation of the ejaculation, and safety outcomes. The only complication was a prostatic abscess, treated with transperineal drainage and antibiotic.

    Study included in systematic review added to the summary of evidence.

    Frego N, Saita A, Casale P, et al. Feasibility, safety, and efficacy of ultrasound-guided transperineal laser ablation for the treatment of benign prostatic hyperplasia: a single institutional experience. World J Urol 2021; 39: 3867–3873.

    Retrospective study

    N=22 patients with BPH had US guided TPLA.

    Follow-up 12 months

    14% (3/22) of patients had acute urinary retention and 9% (2/22) had UTI. At 3, 6, and 12 months, median prostate volume significantly decreased by q 21%, 29%, and 41%, respectively. Median IPSS was 8 (−64%), 5 (−74%), and 6 (−75%), while median QoL score was 1 in all the timepoints of follow-up. The median postoperative Qmax at 3, 6, and 12 months improved by 58%, 98%, and 116%, respectively. Ejaculatory function was preserved in 21 out of 22 patients (96%).

    Study included in systematic review added to the summary of evidence.

    Laganà A, Di Lascio G, Di Blasi A, et al. Ultrasound-guided SoracteLite™ transperineal laser ablation (TPLA) of the prostate for the treatment of symptomatic benign prostatic hyperplasia (BPH): a prospective single-center experience. World J Urol 2023; 41: 1157–1162.

    Prospective study

    n=63 patients with symptomatic BPH had TPLA.

    Follow-up 12 months

    At 12 months, IPSS improved from 20.8 to 8.4 (p<0.001), QoL from 4.7 to 1.2 (p<0.001), and Qmax from 8.6 mL/s to 16.2 mL/s (p=0.014). PVR decreased from 124.8 mL to 40.6 mL (p=0.003), and prostate volume decreased from 63.6 mL to 42.8 mL (p=0.071). Two patients had prostatic abscess and 1 patient had orchitis. TPLA for symptomatic BPH provides clinical benefits at 3 and 12 months, and the treatment is well tolerated.

    Study included in systematic review added to the summary of evidence.

    Lorenzoni V, Palla I, Manenti G et al. (2023) Standard approach and future perspective for the management of benign prostatic hyperplasia from a health-economics point of view: the role of transperineal laser ablation. Front. Urol. 3:1100386. doi: 10.3389/fruro.2023.1100386

    literature review on economic implications.

    Economic literature on minimally invasive techniques and surgical approaches for the treatment of BPH is still lacking. Multicentre and long-term economic studies are needed to assess the estimated disease burden. However, direct and indirect costs associated with TPLA are minimized vs TURP and laser vaporization/enucleation.

    Review

    Manenti G, Perretta T, Calcagni A, et al. 3-T MRI and clinical validation of ultrasound-guided transperineal laser ablation of benign prostatic hyperplasia. Eur Radiol Exp 2021; 5: 41.

    NCT04044573

    Prospective study N=44 patients with BPH underwent US-guided TPLA.

    Follow-up 1 year.

    53% mean reduction of adenoma volume and 71% of the ablated area, associated with clinical and functional improvement and resolution of LUTS in all cases. 11% (5/44) had urinary blockage due to clots and required re-catheterisation for 2 weeks. The overall adverse event rate was 7%.

    Study included in systematic review added to the summary of evidence.

    Nguyen DD, Li T, Ferreira R et al. (2024) Ablative minimally invasive surgical therapies for benign prostatic hyperplasia: A review of Aquablation, Rezum, and transperineal laser prostate ablation. Prostate Cancer Prostatic Dis. 2024 Mar;27(1):22-28.

    Review of three ablative minimally invasive surgeries: Aquablation therapy, convective water vapor therapy (Rezum), and TPLA (diode laser source).

    Ablative minimally invasive surgical therapies have demonstrated excellent safety and efficacy profiles while preserving sexual function. These modalities should be discussed with patients to ensure informed and shared decision-making. These may be interesting to patients who value the preservation of their sexual function.

    Review

    Pacella CM, Patelli G, Iapicca G, et al. Transperineal laser ablation for percutaneous treatment of benign prostatic hyperplasia: a feasibility study. Results at 6 and 12 months from a retrospective multi-centric study. Prostate Cancer Prostatic Dis 2020; 23: 356–363.

    Retrospective multi-centre study

    n=160 patients with urinary symptoms secondary to BPH underwent TPLA.

    Follow-up 6 (n=160) and 12 months (n=83).

    SoracteLite™ TPLA allows significant improvement of IPSS, Qol, Qmax, PVR, and reduction of prostatic volume at 6 and 12 months. 7 (4%) grade 1 and 1 grade 3 complications occurred.

    Study included in systematic review added to the summary of evidence.

    Patelli G, Ranieri A, Paganelli A, et al. Transperineal laser ablation for percutaneous treatment of benign prostatic hyperplasia: a feasibility study. Cardiovasc Intervent Radiol 2017; 40: 1440–1446.

    Prospective single centre pilot trial

    N=18 patients with urinary symptoms secondary to BPH underwent TPLA.

    Follow-up 3 months.

    All procedures were technically successful. No complications occurred. TPLA is feasible and safe in the treatment of BPH, providing significant clinical results at 3 months.

    Study included in systematic review added to the summary of evidence.

    Porto JG, Titus R, Camargo F et al. (2024) Minimally invasive techniques in quest of Holy Grail of surgical management of enlarged prostates: a narrative review. World J Urol. 42(1):35.

    Review

    This review provides valuable insights for urologists and researchers seeking to navigate the dynamic landscape of MISTs (including TPLA) in the quest for effective and minimally invasive solutions for enlarged prostates.

    Review

    Sessa F, Polverino P, Bisegna C, et al. Transperineal laser ablation of the prostate with EchoLaser™ system: perioperative and short term functional and sexual outcomes. Front Urol 2022; 2.

    Prospective study

    N=30 patients underwent TPLA for BPH.

    Follow-up 6 months.

    Our experience provides additional evidence supporting the feasibility and safety of TPLA for the treatment of carefully selected patients with LUTS due to BPH.

    Study included in systematic review added to the summary of evidence.

    Sessa F, Polverino P, Siena G et al. (2023) Transperineal Laser Ablation of the Prostate (TPLA) for Lower Urinary Tract Symptoms Due to Benign Prostatic Obstruction. J Clin Med. 19;12(3):793. doi: 10.3390/jcm12030793. PMID: 36769454; PMCID: PMC9918261.

    Review  of TPLA for LUTS due to BPH.

    n=7 studies (case series)

    A good safety profile has been reported by all studies. Although promising results have been reported by different groups, selection criteria for TPLA and procedure technique were found to be heterogeneous across the studies.

    Review

    Cocci A, Pezzoli M, Bianco F et al. (2024) Transperineal laser ablation of the prostate as a treatment for benign prostatic hyperplasia and prostate cancer: The results of a Delphi consensus project. Asian J Urol.11(2):271-279.

    Italian and international experts (32) on BPH and prostate cancer participated in a collaborative consensus project.

    Agreement was achieved on recommending Echolaser TPLA as a treatment of BPH in patients with ample range of prostate volume, from 80 mL (80%), comorbidities (100%), antiplatelet or anticoagulant treatment (96%), indwelling catheter (77%), and strong will of preserving ejaculatory function (100%). Majority of respondents (97%) agreed that Echolaser. Almost all participants agreed that the transperineal approach of this organ-sparing technique is safer than transrectal and transurethral approaches typical of other techniques.

    Consensus report.