Thulium fiber laser vs. holmium laser enucleation of the prostate: results of a prospective randomized non-inferiority trial

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Abstract

Purpose

Holmium laser enucleation of the prostate (HoLEP) represents the current standard procedure for size-independent surgical therapy of benign prostatic obstruction (BPO). With advent of the novel laser technology thulium fiber laser (TFL), we hypothesized that the functional outcome of TFL enucleation of the prostate (ThuFLEP) is non-inferior compared to HoLEP.

Methods

From October 2021 to October 2022, 150 patients with BPO were recruited for the prospective randomized trial in accordance with CONSORT. Stratified randomization into the arms ThuFLEP ( n = 74) or HoLEP ( n = 76) was carried out. The primary endpoint was non-inferior international prostate symptom score (IPSS) and quality of life (QoL) at three months after treatment. Secondary endpoints were rates of complications, peak flow, residual urine and operation times.

Results

Preoperative characteristics showed no significant differences. Overall IPSS and QoL improved from 21 to 8 and 4 to 1.5, respectively, after three months of follow-up. No statistically significant differences between ThuFLEP and HoLEP were observed regarding median postoperative IPSS (8.5 vs. 7, p > 0.9), QoL (1 vs. 2, p = 0.6), residual urine (48 vs. 30ml, p = 0.065) and peak flow (19 vs. 17ml/s, p > 0.9). Similarly, safety profile was comparable with no statistically significant differences regarding rate of major complications (5.3 vs. 5.4%, p = 0.5), laser hemostasis time (3 vs. 2min, p = 0.2), use of additive electric coagulation (74 vs. 87%, p = 0.06) or electric coagulation time (8 vs. 8min, p = 0.4).

Conclusions

In this prospective, randomized trial ThuFLEP showed non-inferior results compared to HoLEP in terms of functional outcomes measured by IPSS and QoL as primary endpoint.

Trial registration number

DRKS00032699 (18.09.2023, retrospectively registered).

Supplementary Information

The online version contains supplementary material available at 10.1007/s00345-023-04748-7.

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Most cited references 30

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The Clavien-Dindo classification of surgical complications: five-year experience.

Pierre A. Clavien, Jeffrey Barkun, Michelle L. de Oliveira … (2009)

The lack of consensus on how to define and grade adverse postoperative events has greatly hampered the evaluation of surgical procedures. A new classification of complications, initiated in 1992, was updated 5 years ago. It is based on the type of therapy needed to correct the complication. The principle of the classification was to be simple, reproducible, flexible, and applicable irrespective of the cultural background. The aim of the current study was to critically evaluate this classification from the perspective of its use in the literature, by assessing interobserver variability in grading complex complication scenarios and to correlate the classification grades with patients', nurses', and doctors' perception. Reports from the literature using the classification system were systematically analyzed. Next, 11 scenarios illustrating difficult cases were prepared to develop a consensus on how to rank the various complications. Third, 7 centers from different continents, having routinely used the classification, independently assessed the 11 scenarios. An agreement analysis was performed to test the accuracy and reliability of the classification. Finally, the perception of the severity was tested in patients, nurses, and physicians by presenting 30 scenarios, each illustrating a specific grade of complication. We noted a dramatic increase in the use of the classification in many fields of surgery. About half of the studies used the contracted form, whereas the rest used the full range of grading. Two-thirds of the publications avoided subjective terms such as minor or major complications. The study of 11 difficult cases among various centers revealed a high degree of agreement in identifying and ranking complications (89% agreement), and enabled a better definition of unclear situations. Each grade of complications significantly correlated with the perception by patients, nurses, and physicians (P < 0.05, Kruskal-Wallis test). This 5-year evaluation provides strong evidence that the classification is valid and applicable worldwide in many fields of surgery. No modification in the general principle of classification is warranted in view of the use in ongoing publications and trials. Subjective, inaccurate, or confusing terms such as "minor or major" should be removed from the surgical literature.

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High-power thulium fiber laser ablation of urinary tissues at 1.94 microm.

Nathaniel M Fried, Keith E Murray (2015)

This paper describes the preliminary testing of a new laser, the thulium fiber laser, as a potential replacement for the holmium:YAG laser for multiple applications in urology. A 40 W thulium fiber laser operating at a wavelength of 1.94 microm delivered radiation in a continuous-wave or pulsed mode (10 msec) through either 300-microm- or 600-microm-core low-OH silica fibers for vaporization of canine prostate and incision of animal ureter and bladder-neck tissues. The thulium fiber laser vaporized prostate tissue at a rate of 0.21+/-0.02 g/min. The thermal-coagulation zone measured 500 to 2000 microm, demonstrating the potential for hemostasis. Laser incisions were also made in bladder tissue and ureter, with coagulation zones of 400 to 600 microm. The thulium fiber laser has several potential advantages over the holmium laser, including smaller size, more efficient operation, more precise incision of tissues, and operation in either the pulsed or the continuous-wave mode. However, before clinical use will be possible, development of higher-power thulium fiber lasers and shorter pulse lengths will be necessary for rapid vaporization of the prostate and more precise incision of urethral/bladder-neck strictures, respectively.

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The laser of the future: reality and expectations about the new thulium fiber laser—a systematic review

Peter Kronenberg, Olivier Traxer (2019)

The Holmium:yttrium-aluminum-garnet (Ho:YAG) laser has been the gold-standard for laser lithotripsy over the last 20 years. However, recent reports about a new prototype thulium fiber laser (TFL) lithotripter have revealed impressive levels of performance. We therefore decided to systematically review the reality and expectations for this new TFL technology. This review was registered in the PROSPERO registry (CRD42019128695). A PubMed search was performed for papers including specific terms relevant to this systematic review published between the years 2015 and 2019, including already accepted but not yet published papers. Additionally, the medical sections of ScienceDirect, Wiley, SpringerLink, Mary Ann Liebert publishers, and Google Scholar were also searched for peer-reviewed abstract presentations. All relevant studies and data identified in the bibliographic search were selected, categorized, and summarized. The authors adhered to PRISMA guidelines for this review. The TFL emits laser radiation at a wavelength of 1,940 nm, and has an optical penetration depth in water about four-times shorter than the Ho:YAG laser. This results in four-times lower stone ablation thresholds, as well as lower tissue ablation thresholds. As the TFL uses electronically-modulated laser diodes, it offers the most comprehensive and flexible range of laser parameters among laser lithotripters, with pulse frequencies up to 2,200 Hz, very low to very high pulse energies (0.005–6 J), short to very long-pulse durations (200 µs up to 12 ms), and a total power level up to 55 W. The stone ablation efficiency is up to four-times that of the Ho:YAG laser for similar laser parameters, with associated implications for speed and operating time. When using dusting settings, the TFL outperforms the Ho:YAG laser in dust quantity and quality, producing much finer particles. Retropulsion is also significantly reduced and sometimes even absent with the TFL. The TFL can use small laser fibers (as small as 50 µm core), with resulting advantages in irrigation, scope deflection, retropulsion reduction, and (in)direct effects on accessibility, visibility, efficiency, and surgical time, as well as offering future miniaturization possibilities. Similar to the Ho:YAG laser, the TFL can also be used for soft tissue applications such as prostate enucleation (ThuFLEP). The TFL machine itself is seven times smaller and eight times lighter than a high-power Ho:YAG laser system, and consumes nine times less energy. Maintenance is expected to be very low due to the durability of its components. The safety profile is also better in many aspects, i.e., for patients, instruments, and surgeons. The advantages of the TFL over the Ho:YAG laser are simply too extensive to be ignored. The TFL appears to be a real alternative to the Ho:YAG laser and become a true game-changer in laser lithotripsy. Due to its novelty, further studies are needed to broaden our understanding of the TFL, and comprehend the full implications and benefits of this new technology, as well its limitations.

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Author and article information

Contributors

Maximilian Filzmayer:

ORCID: http://orcid.org/0009-0005-5715-9965

filzmayer@med.uni-frankfurt.de

Journal

Journal ID (nlm-ta): World J Urol

Journal ID (iso-abbrev): World J Urol

Title: World Journal of Urology

Publisher: Springer Berlin Heidelberg (Berlin/Heidelberg )

ISSN (Print): 0724-4983

ISSN (Electronic): 1433-8726

Publication date (Electronic): 20 January 2024

Publication date PMC-release: 20 January 2024

Publication date (Print): 2024

Volume: 42

Issue: 1

Electronic Location Identifier: 49

Affiliations

[1 ]Department of Urology, Goethe University Frankfurt, University Hospital, ( https://ror.org/04cvxnb49) Frankfurt, Germany

[2 ]Urological Center at Boxberg, Neunkirchen, Germany

Author information

Maximilian Filzmayer http://orcid.org/0009-0005-5715-9965

Article

Publisher ID: 4748

DOI: 10.1007/s00345-023-04748-7

PMC ID: 10799774

PubMed ID: 38244076

SO-VID: 9f61a27b-8994-4f41-9a17-745a8c9d4ea4

License:

Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.

History

Date received : 21 September 2023

Date accepted : 24 October 2023

Funding

Funded by: Johann Wolfgang Goethe-Universität, Frankfurt am Main (1022)

Open Access :

Open Access funding enabled and organized by Projekt DEAL.

Custom metadata

ScienceOpen disciplines: Urology

Keywords: lower urinary tract symptoms,laser enucleation of the prostate,thulium fiber laser,soltive™,holmium laser,thuflep,holep

Data availability:

ScienceOpen disciplines: Urology

Keywords: lower urinary tract symptoms, laser enucleation of the prostate, thulium fiber laser, soltive™, holmium laser, thuflep, holep

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Thulium fiber laser vs. holmium laser enucleation of the prostate: results of a prospective randomized non-inferiority trial

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Most cited references 30

The Clavien-Dindo classification of surgical complications: five-year experience.

High-power thulium fiber laser ablation of urinary tissues at 1.94 microm.

The laser of the future: reality and expectations about the new thulium fiber laser—a systematic review

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