Cryotherapy versus radical prostatectomy as a salvage treatment for radio-recurrent prostate cancer.

INTRODUCTION: The aim of this study is to compare outcomes of SRP (salvage radical prostatectomy) with SCAP (salvage cryoablation of the prostate) in local radio-recurrent PCa (prostate cancer) patients. MATERIALS AND METHODS: A retrospective analysis of a multicentric European Society of Uro-technology (ESUT) database was performed. Data on patients with local recurrent PCa after radiotherapy who underwent salvage treatment were collected. Patients and their respective disease characteristics, perioperative complications as well as oncological outcomes were then described. The treatment success rate was defined as PSA nadir < 0,4 ng/ml. Any complications were graded according to the modified Clavien system. A descriptive and comparative analysis was performed using SPSS software. RESULTS: 25 patients underwent SRP and 71 patients received SCAP. The mean follow-up was 24 months. The median PSA level before initial treatment was 8.3 (range 7-127) ng/ml. The success rates of SRP and SCAP were largely comparable (88% (22 patients) vs. 67.7% (48 patients), respectively, p = 0.216). The mean serum PSA levels at 12 months after salvage treatment were 1.2 ± 0.2 ng/mL vs. 0.25 ± 0.5 ng/mL, p > 0.05). During the follow-up period, only 3 (12%) patients in the SRP group had PSA recurrence compared with 21 patients (29.6%) in the SCAP group. The 5-year BRFS was similar (51,6% and 48,2%, p = 0,08) for SRP and SCAP respectively. The 5-year overall survival rate was 91.7%, and 89,7% (p = 0.669) and the 5-year cancer-specific survival was 91.7%, and 97,1% (p = 0.077), after SRP and SCAP respectively. No difference was found regarding the complications. CONCLUSIONS: Both SRP and SCAP should be considered as valid treatment options for patients with local recurrence of PCa after radiotherapy. SCAP has a potentially lower risk of morbidity and acceptable intermediate-term oncological efficacy, but a longer follow up and a higher number of patients is ideally needed to draw any long-term conclusions regarding the oncological data.

Holmium laser with MOSES technology (MoLEP) vs Thulium fiber laser enucleation of the prostate (ThuFLEP) in a real-world setting. Mid-term outcomes from a multicenter propensity score analysis.

PURPOSE: To compare Holmium laser with MOSES technology (MoLEP) and Thulium fiber laser enucleation of the prostate (ThuFLEP) in terms of surgical and functional outcomes. METHODS: We performed a retrospective analysis of all patients who underwent either procedure in five centers (January 2020-January 2022). EXCLUSION CRITERIA: previous urethral/prostatic surgery, radiotherapy, concomitant surgery. Propensity score matching (PSM) analysis was performed to adjust for the bias inherent to the different characteristics at baseline. Differences between procedures were estimated using Firth Penalized Likelihood regression for International prostate symptom score (IPSS), quality of life (QL), maximum flow rate (Qmax). RESULTS: PSM retrieved 118 patients in each group. Baseline characteristics were similar except for PSA and number of men on indwelling catheter (higher in MoLEP group). Median surgical time was significantly longer in the MoLEP group despite the enucleation and morcellation times being similar. Median catheter dwelling time and postoperative length of stay were similar. Most of the early complications were Clavien ≤ 2 grade. There were only two Clavien grade 3 complications (one for each group), one grade 4 in MoLEP group. Rate and type of early and persistent incontinence (> 3 months) were similar. At 12-month, proportion of patients reaching a decrease (Δ) of IPSS ≥ 18 from baseline was significantly larger in MoLEP group, with no significant difference in ΔQmax > 12 ml/sec and ΔQL ≥ -3. CONCLUSION: MoLEP and ThuFLEP were safe and efficacious procedures with similar short-term operative and functional outcomes. At 1-year, MoLEP patients had a sustained reduction of IPPS score.

Thulium fiber laser vs Ho:YAG in RIRS: a prospective randomized clinical trial assessing the efficacy of lasers and different fiber diameters (150 µm and 200 µm).

INTRODUCTION: The aims of the study: (1) to compare the Super Pulse Thulium Fiber Laser (SP TFL) and the holmium: yttrium-aluminium-garnet (Ho:YAG) lasers in retrograde intrarenal surgery (RIRS); (2) to compare the efficacy of SP TFL laser fibers of different diameters (150 µm and 200 µm). METHODS: A prospective randomized single-blinded trial was conducted. Patients with stones from 10 to 20 mm were randomly assigned RIRS in three groups: (1) SP TFL (NTO IRE-Polus, Russia) with fiber diameter of 150 µm; (2) SP TFL with 200-µm fiber; and (3) Ho:YAG (Lumenis, USA) with 200-µm fiber. RESULTS: Ninety-six patients with kidney stones were randomized to undergo RIRS with SP TFL using a 150-µm fiber (34 patients) and a 200-µm fiber (32 patients) and RIRS with Ho:YAG (30 patients). The median laser on time (LOT) in the 200-µm SP TFL group was 9.2 (6.2-14.6) min, in 150-µm SP TFL-11.4 (7.7-14.9) min (p = 0.390), in Ho:YAG-14.1 (10.8-18.1) min (p = 0.021). The total energy consumed in 200-µm SP TFL was 8.4 (5.8-15.2) kJ; 150-µm SP TFL - 10.8 (7.3-13.5) kJ (p = 0.626) and in Ho:YAG-15.2 (11.1-25.3) kJ (p = 0.005). CONCLUSIONS: Irrespective of the density, RIRS with SP TFL laser has proven to be both a safe and effective procedure. Whilst the introduction of smaller fibers may have the potential to reduce the duration of surgery, SP TFL results in a reduction in the LOT and total energy for stone ablation in RIRS compared with Ho:YAG.

Comparison of EEP and TURP long-term outcomes: systematic review and meta-analysis.

OBJECTIVE: To compare long-term reoperation rate and functional outcomes between EEP (endoscopic enucleation of the prostate) and TURP (transurethral resection of the prostate). EVIDENCE ACQUISITION: A systematic literature review of Medline, Scopus, and Web of Science was conducted with primary outcome assessed being reoperation rate and secondary outcomes after a long term (> 3 years) being functional outcomes or related values (prostate volume, PSA level, etc.). EVIDENCE SYNTHESIS: Five studies were found with long-term follow-up 4-7 years. EEP reoperation rate ranged from 0 to 1.27%, while from 1.7 to 17.6% for TURP. Meta-analysis showed significantly lower OR for EEP, 0.27 (95% CI 0.24-0.31), with notable homogeneity of the results, I2 = 0%. Long-term Qmax and IPSS were significantly better for EEP. Qmax pooled mean difference was 1.79 (95% CI 1.72-1.86) ml/s with a high concordance among the studies, I2 = 0%. IPSS mean difference -1.24 (95% CI - 1.28 to - 1.2) points, I2 = 57% but QoL did not differ, with mean difference being 0.01 (95% CI - 0.02 to 0.04), I2 = 0%. IIEF-5 score was also significantly better for EEP, mean difference 1.08 (95% CI 1.03-1.13), but heterogeneity was high, I2 = 70%. PSA level and prostate volume were only reported in one study and favored EEP slightly yet statistically significant. CONCLUSION: EEP had a significantly lower reoperation rate and better functional outcomes (Qmax and IPSS) at long term compared with TURP. It may also be beneficial in terms of IIEF-5, PVR, and PSA level.

Thulium fiber laser in endourology: current clinical evidence.

PURPOSE OF REVIEW: To review and summarize preclinical and clinical data on thulium fiber laser's (TFL) effectiveness (ablation rate, stone-free rate etc.) and safety in terms of laser injuries and thermal damage. This enables us to assess how the in-vitro evidence translates into the clinical real-life scenario. RECENT FINDINGS: In this analysis, a total of 21 preclinical trials have been included. Most of the trials use conventional Holmium:YAG laser as a comparator, with only a few assessing lasers with pulse modulation. Most of the trials focus on the superior ablation rate and superior dusting features of TFL, as well as comparison of retropulsion (both in conventional Ho:YAG and in a pulse modulation), with a few studies assessing safety aspects. A total of 13 trials assessed TFL, clinically, in percutaneous nephrolithotomy (PCNL) and retrograde intrarenal surgery (RIRS). The clinical data obtained suggest that lithotripsy by TFL is safe, facilitates effective stone fragmentation, and results in a reduction of retropulsion. Unfortunately, most of the clinical trials lack a direct comparator, and so no clear-cut comparisons are possible. SUMMARY: During in-vitro studies, TFL demonstrated to be a new energy source with a great potential for improved ablation, lower retropulsion and improved dusting. These claims are supported in contemporary clinical studies, reporting superior ablation and negligible retropulsion in both PCNL and RIRS. However, it should be noted that the data regarding clinical results compared with conventional Ho:YAG is still limited.

A systematic review and meta-analysis of placebo effect in clinical trials on chronic prostatitis/chronic pelvic pain syndrome.

BACKGROUND: It is a common practice to control efficacy of pharmacological treatment with a placebo group. However, placebo itself may affect subjective and even objective results. The purpose of this study was to evaluate the placebo effect on symptoms of CP/CPPS to improve future clinical trials. METHODS: A search at three databases (Scopus, MEDLINE, and Web of Science) was conducted to identify double-blind placebo-controlled clinical trials on the treatment of CP/CPPS published until April 2021. The primary outcome - National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) score. SECONDARY OUTCOMES: Qmax, PVR, IPSS, and prostate volume. RESULTS: A total of 3502 studies were identified. Placebo arms of 42 articles (5512 patients, median 31 patients) were included in the systematic review. Systematic review identified positive changes in the primary endpoint, meta-analysis of 10 articles found that NIH-CPSI total score results were significantly influenced by placebo, mean difference -4.2 (95% confidence interval [CI]: -6.31, -2.09). Mean difference of NIH-CPSI pain domain was -2.31 (95% CI: -3.4, -1.21), urinary domain -1.12 (95% CI: -1.62, -0.62), quality of life domain -1.67 (95% CI: -2.38, -0.96); p < 0.001 for all. In case of the objective indicator - Qmax, there were three articles included in the meta-analysis. Qmax mean change from baseline was 0.68 (95% CI: -0.85, 2.22, p = 0.38). Systematic review showed no significant changes in pain, measured by VAS or other scores, IPSS and PVR. CONCLUSIONS: Placebo significantly affected the subjective parameters (NIH-CPSI) and limitedly affected various other measurements of pain (visual analog scale, McGill pain questionnaire). There was no long-term effect on IPSS and objective measurements (Qmax, PVR). This study can be used in further clinical trials to develop general rules of CPPS treatment assessment.

Randomized prospective trial of the severity of irritative symptoms after HoLEP vs ThuFLEP.

PURPOSE: To compare the short-term postoperative functional outcomes and severity of irritative symptoms following holmium and thulium fiber laser enucleation (HoLEP and ThuFLEP). METHODS: This prospective randomized single-blinded study was performed in accordance with CONSORT. The inclusion criteria were IPSS > 20 or Qmax < 10 ml/s. Patients were randomized between HoLEP and ThuFLEP. Demographics, objective data (PSA, prostate volume, etc.), data on urinary and sexual function (IPSS, IIEF, QoL, QUID, Qmax, ICIQ-MLUTS) were collected. Detailed perioperative information and postoperative data on functional outcomes at 1, 2, 3, 4, 6, 8, 10, 12 weeks and 6 months were collected. RESULTS: Data on 163 participants were included (77-HoLEP, 86-ThuFLEP). No differences were found in surgery duration; number of postoperative complications (Clavien-Dindo I-III), catheterization time and hospital stay. Functional outcomes up to 6 months didn't differ between the groups (IPPS, IIEF, QoL, QUID, ICIQ-MLUTS, Qmax, p > 0.05). Total ICIQ-MLUTS, bother and voiding scores at 1 and 3 months significantly increased compared with the baseline in both groups (p < 0.05). No difference between the groups were observed. In HoLEP the SUI series rate was 1.3% and 1.3% after 3 and 6 months following the procedure; in ThuFLEP: it was 3.5% and 2.3% respectively (p = 0.35 and p = 0.54). CONCLUSION: The preliminary results of the study showed no apparent differences in functional outcomes (IPSS, Qmax), rate of SUI or irritative symptoms. Both ThuFLEP and HoLEP are efficient ways of treating benign prostatic obstruction. Both surgeries are comparable in terms of duration and postoperative complication rates.

Thulium fiber laser in urology: physics made simple.

PURPOSE OF REVIEW: In this narrative review, we will focus on a novel thulium fiber laser's physical properties in terms of its clinical applicability. RECENT FINDINGS: TFL has successfully moved forward from the preclinical trials into clinical practice and now is being widely used in clinics around the world. The available data suggest that the device effectively operates in soft tissues - benign prostate hyperplasia (BPH) and bladder tumors, as well as in lithotripsy. Also, the first promising results were obtained from laparoscopic surgery showing its possible applicability in the management of renal cell carcinoma. The constructional changes in fiber laser's design, lead to alteration of laser-tissue interactions, which resulted in clinical advantages of the device. Yet, the exact mechanism often is considered complex for understanding. With this work, we are aiming to build a bridge between biophysics and clinical practice and give a simple explanation of how the devices is working and why the knowledge of it is important for a clinician. SUMMARY: The more effective wavelength (closer to the water absorption peak), favorable beam profile, different modes of action allowing to decrease carbonization on one hand and retropulsion on the other, all this makes TFL an evolution in urologic surgery. Further trials investigating on the possible pros and cons of the device are awaited.

Prospective Single-Center Study of SuperPulsed Thulium Fiber Laser in Retrograde Intrarenal Surgery: Initial Clinical Data.

INTRODUCTION: The objective of this study was to present our clinical experience of using the thulium fiber laser in retrograde intrarenal surgery (RIRS). METHODS: A prospective clinical study performed after the IRB approval (Sechenov University, Russia). Patients with stones <30 mm were treated with SuperPulsed thulium fiber laser (SP TFL) (NTO IRE-Polus, Russia) through a 200-µm-diameter fiber. Stone size, density, the duration of the operation, and laser on time (LOT) were measured. Based on the surgeon's feedback, retropulsion and intraoperative visibility were also assessed (Likert scale). Stone-free rates (SFRs) were assessed with a low-dose CT scan 90 days after the operation. RESULTS: Between January 2018 and December 2019, 153 patients (mean age 54 ± 2.8 years) underwent RIRS with SP TFL (mean stone density 1,020 ± 382 HU). Median stone volume was 279.6 (139.4-615.8) mm3. Median LOT was 2.8 (IQR 1.6-6.6) min with median total energy for stone ablation 4.0 (IQR 2.1-7.17) kJ, median ablation speed was 1.7 (1.0-2.8) mm3/s, median ablation efficacy was 13.3 (7.3-20.9) J/mm3, and energy consumption was 170.3 (59.7-743.3) J/s. Overall, the SFR (at 3 months) was 89%. The overall complication rate was 8.4%. Retropulsion was present in 23 (15.1%) patients. Visibility was estimated as optimal in most patients, with poor visibility reported in only 13 (8.5%) patients. CONCLUSION: The SP TFL is a safe and efficient tool in lithotripsy, irrespective of the stone type and density. Retropulsion is minimal and visibility is maintained with SP TFL. Nonetheless, further clinical studies are needed to ensure optimal comparison with conventional holmium:YAG lithotripsy.

EAU, AUA and NICE Guidelines on Surgical and Minimally Invasive Treatment of Benign Prostate Hyperplasia: A Critical Appraisal of the Guidelines Using the AGREE-II Tool.

OBJECTIVE: To critically appraise the methodological rigour of the clinical practice guidelines (CPGs) vis-à-vis BPH surgery as used by specialist research associations in the US, Europe and UK, and to compare whether the guidelines cover all or only some of the available treatments. METHODS: The current guidelines issued by the EUA, AUA and NICE associations have been analyzed by 4 appraisers using the AGREE-II instrument. We also compared the recommendations given in the guidelines for surgical and minimally invasive treatment to find out which of these CPGs include most of the available treatment options. RESULTS: According to the AGREE II tool, the median scores of domains were: domain 1 scope and purpose 66.7%, domain 2 stakeholder involvement 50.0%, domain 3 rigor of development 65.1%, domain 4 clarity of presentation 80.6%, domain 5 applicability 33.3%, domain 6 editorial independence 72.9%. The overall assessment according to AGREE II is 83.3%. The NICE guideline scored highest on 5 out of 6 domains and the highest overall assessment score (91.6%). The EAU guideline scored lowest on 4 out of 6 domains and has the lowest overall assessment score (79.1%). CONCLUSIONS: The analyzed CPGs comprehensively highlight the minimally invasive and surgical treatment options for BPH. According to the AGREE II tool, the domains for clarity of presentation and editorial independence received the highest scores. The stakeholder involvement and applicability domains were ranked as the lowest. Improving the CPG in these domains may help to improve the clinical utility and applicability of CPGs.