Purpose: The objective of this study was to evaluate the efficacy and safety of the newer, thulium fiber laser enucleation of the prostate (ThuFLEP) versus the transurethral resection of the prostate (TURP) for medium- to large-volume benign prostatic hyperplasia (BPH). Materials and Methods: We performed a single-center retrospective study between May 2020 and June 2021. Among these, we included patients >50 years of age, with prostate size >80 cc, International Prostate Symptom Score (IPSS) >19, and maximum urine flow rate (Qmax) <15 mL/s. All patients underwent either TURP or ThuFLEP. Preoperative parameters such as IPSS score, quality of life (QoL) score, Qmax, and residual urine were assessed. Results: Of the total of 101 patients, 29 underwent ThuFLEP and 72 TURP. The mean prostate volume was significantly higher in the ThuFLEP group compared to the TURP (P = 0.01). The mean operative time was longer for ThuFLEP compared to TURP (P < 0.0001). No significant difference was noted in the postoperative hematuria (P = 0.29) and mean postoperative hemoglobin (P = 0.37). The QoL scores were significantly improved with ThuFLEP than TURP (P = 0.0006). Compared to a day after catheter removal, the proportion of patients with stress, urge, and total incontinence was significantly reduced at the end of 1 month in the ThuFLEP group (P < 0.00001); however, it was significantly greater than with TURP (P < 0.05). At 3 months, no significant difference was found between IPSS (P = 0.37) and Qmax (P = 0.98) scores between the groups; however, the decrease from baseline was significant for IPSS (P < 0.0001). The Clavien–Dindo Grade I and II complications were 31% and 13.8%, respectively, for ThuFLEP and 8.3% and 1.4% for TURP. There was no significant difference of patients with late complications. Conclusion: ThuFLEP demonstrated efficacy similar to TURP in medium- to larger-size BPH in terms of IPSS and Qmax but had significant improvement in QoL scores. The overall complications with ThuFLEP were higher as compared to TURP.
Keywords: Benign prostatic hyperplasia, endoscopic enucleation of the prostate, thulium fiber laser, transurethral resection of the prostate
|How to cite this URL:|
Mahajan AD, Mahajan SA. A comparative study of the efficacy of thulium fiber laser enucleation and transurethral resection for medium- to large-size prostate. Urol Sci [Epub ahead of print] [cited 2023 Dec 1]. Available from: https://www.e-urol-sci.com/preprintarticle.asp?id=377441
| Introduction|| |
Surgical treatment of symptomatic benign prostatic hyperplasia (BPH) involves the elimination of the impeding adenomatous tissue through the transurethral route using monopolar electroconductivity. Transurethral resection of the prostate (TURP) using either the monopolar or bipolar approach is recommended as a treatment option for men with lower urinary tract symptoms (LUTSs) attributed to BPH for relieving bladder outlet obstruction (BOO) secondary to BPH. However, TURP carries a significant risk of morbidity (18%) and a slight risk of mortality (0.1%)., TURP is equally effective for both midsized and large prostates (>80–150 mL), whereas for large adenomas, enucleation is performed by open simple prostatectomy (OSP) (i.e., retropubic or suprapubic).,, In patients with large prostates, TURP might require two sittings and open prostatectomy are associated with relatively high transfusion (9.5%) and revision (9.8%) rates and prolonged hospital stay (11.9 days).,
Owing to these considerations, several methods, including endoscopic enucleation of the prostate (EEP), based on complete removal of the adenoma from the surgical capsule, and subsequent morcellation have been evolving. These procedures have been recommended by the updated the European Association of Urology (EAU) guidelines and the American Urology Association (AUA) and are used regardless of the prostate size based on the surgeon's proficiency.,
Among the various newer EEP techniques, holmium laser enucleation of the prostate (HoLEP) is considered the gold standard and is widely used. The relatively newer thulium fiber laser (TFL) technique may be preferred over HoLEP in the future because the TFL wavelength (1940 nm) exactly matches the water absorption peak in the tissues, unlike the holmium laser wavelength (2120 nm).
Thulium fiber laser enucleation of the prostate (ThuFLEP) reduces the thermal damage zone by fourfold (100 μm) and reduces the risk of scarring. However, clinical comparisons between ThuFLEP and TURP and HoLEP are still limited in large gland BPH. Therefore, we evaluated and compared the efficacy and complication rates of ThuFLEP with the standard TURP in patients with moderate to large-sized prostate BPH.
| Materials and Methods|| |
This retrospective single-center study was conducted between May 2020 and June 2021. A total of 101 patients suffering from significant LUTS were reviewed, among whom, 29 patients underwent ThuFLEP and 72 underwent TURP. Ethical approval was obtained from Sai Urology Hospital Ethics Committee (Letter No. ECRHS/2020/04/02, dated April 15, 2020). Written informed consent was obtained from each patient before the procedure.
We evaluated data of patients >50 years, with a prostate size of >80cc, International Prostate Symptom Score (IPSS score) >19, maximum urine flow rate (Qmax) <15 mL/s, significant postvoid residual urine (PVR), and urinary retention clearly due to prostate enlargement and those who were reluctant to initiate, continue, or failed pharmacological therapy and were vulnerable to disease exacerbation. Patients with neurogenic bladder, associated bladder tumor, carcinoma of the prostate, and stricture urethra were excluded from the study. The demographic and clinical data were obtained for all of the enrolled patients, both preoperatively and postoperatively. Both of the procedures were performed by a single surgeon abhay mahajan (ADM). TURP was performed as per Nesbit's procedure using a standard resectoscope (Karl Storz, Germany) with electrocautery. Resection of the prostate was started from the roof at the 12 o'clock position, continued to the 3 and 9 o'clock position on the either side and then sequentially continued until the floor. The apical tissue was resected last. ThuFLEP was performed with a laser operating element and morcellation using the Piranha system (Richard-Wolf, Germany). A 60-Watt TFL machine (IPG photonics, Russia) was used during enucleation, with laser settings of 36.7 Hz × 1.5 J, a total of 55 W. The ThuFLEP procedure was performed by an “en bloc” early apical mucosal release enucleation technique. The circumferential apical mucosal incision was taken in front of the verumontanum. The floor of the prostate was enucleated starting at the 6 o'clock position and extending to either side from the 4 to 8 o'clock position. Then, the roof incision was deepened from the 10 to 2 o'clock position, before joining the lateral lobes in a circular manner to join the roof and floor incisions. Finally, a single prostate lobe was enucleated and dropped in the bladder. Morcellation of the enucleated gland was performed using the standard technique. The operative time for ThuFLEP included the combined enucleation and morcellation duration, whereas that for TURP was the time taken for the resection and coagulation. The occurrence of gross hematuria was recorded postoperatively. The Foley catheter was removed after 48 h. The observations for incontinence were noted 1, 7, and 30 days after catheter removal. The proportion of patients with postoperative complications related to incontinence stress urinary incontinence (SUI), and urge incontinence (UI) was recorded. The IPSS and Qmax were reassessed 3 months after surgery.
The data were organized in an Excel sheet (Microsoft Office version O365). All statistical analyzes were conducted using SAS Statistics (version 9.3; SAS, Cary, North Carolina, USA). Normally distributed continuous variables are expressed as means ± standard deviations, nonnormally distributed continuous variables are expressed as the medians and interquartile ranges, and categorical variables are described as frequencies and percentages. The independent t-test was conducted to compare continuous variables between the ThuFLEP and TURP groups of patients, the Chi-square test was used to analyze the associations between categorical variables, and the McNemar test on paired proportions was used to compare within-group differences. A P < 0.05 was considered statistically significant.
| Results|| |
From a total of 101 patients suffering from significant LUTS who underwent surgical treatment, 29 patients underwent ThuFLEP and 72 underwent TURP. The demographic and clinical data of the patients in both groups are shown in [Table 1]. There was no significant difference in the mean age, hypertension, diabetes, asthma, cardiac events, and other surgeries between the patients in both groups. The median prostate volume was 87 cc in the ThuFLEP group, which was higher than the 84.0 cc observed in the TURP group, but the difference was not significant. The median preoperative prostate-specific antigen (PSA) was 6.80 ng/mL in the ThuFLEP group, which was significantly higher than the 3.57 ng/dL observed in the TURP group [Table 1].
The preoperative characteristics, including IPSS score (26.22 ± 12.53 vs. 25.67 ± 12; P = 0.83) and quality of life (QoL) score (5.66 ± 0.94 vs. 5.35 ± 0.75; P = 0.08), did not differ significantly between the two groups. The PVR volume (383.11 ± 266.17 mL vs. 299.72 ± 283.87 mL; P = 0.17) was greater, and the Qmax (8.13 ± 4.96 mL/s vs. 9.55 ± 4.79 mL/s; P = 0.18) was lower in the ThuFLEP group compared to the TURP group, but the differences were not significant [Table 2].
|Table 2: Thulium fiber laser enucleation of the prostate versus transurethral resection of the prostate: Comparison of pre- and post-operative parameters|
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The total operative time was significantly longer for ThuFLEP compared to TURP (84.38 ± 17.31 vs. 53.42 ± 17.11; P < 0.0001), with approximately 30 min of additional time required for ThuFLEP. No significant difference was observed between either bilobar (79.31% vs. 83.33%; P = 0.6346) or trilobar prostate enlargement (20.69% vs. 16.67%) between the groups undergoing ThuFLEP or TURP, respectively.
Among the various postoperative parameters recorded, there was no significant difference between hematuria (17.24% vs. 9.72%; P = 0.29) and mean hemoglobin (Hb) [12.39 ± 1.27 vs. 12.10 ± 1.55; P = 0.37, [Table 2]]. None of the patients required blood transfusion, but there was a slight but significant drop in Hb in both groups (−0.75 g% and −0.78 g% in ThuFLEP and TURP, respectively, both P < 0.0001 vs. preoperative Hb). The number of catheter days was slightly longer in the ThuFLEP group than in the TURP group (2.72 ± 0.70 vs. 2.36 ± 0.56; P = 0.0078) but remained at an average of <3 days in both [Table 2]. Following catheter removal, the PVR volume determined by ultrasound showed a significant (P < 0.00001) decrease from baseline in both groups (>90%), whereas there was no significant difference between the groups [28.36 ± 11.56 vs. 28.42 ± 19.27; P = 0.98, [Table 2]]. The QoL scores were significantly improved in patients from the ThuFLEP group compared to those from the TURP group [1.69 ± 0.60 vs. 2.32 ± 0.87; P = 0.0006, [Table 2]].
Among the early complications after catheter removal, SUI, UI, and total incontinence were significantly more common in the ThuFLEP group compared to the TURP group [Figure 1]. Compared to the day after catheter removal, the incontinence declined, and by day 30, none of the patients suffered from SUI. Eight of the initial 10 patients ceased to experience UI in the ThuFLEP group by the end of the 1st month. In the ThuFLEP group, total incontinence was observed in 13.8% of the patients 3 days after catheter removal, which dropped to 3.40%. No patient in the TURP group had total incontinence after 30 days of surgery. Among the late complications due to both surgeries, there were no significant differences in the occurrence of urethral stricture, bladder neck stenosis, and epididymo-orchitis, with each occurring only in a single patient in both groups. Retrograde ejaculation occurred in 9 of 29 (31%) patients in the ThuFLEP group, and 8 of 64 (11%) patients in the TURP group; the difference was not significant (P = 0.86).
According to the Clavien–Dindo classification, 31.0% of the ThuFLEP cases had grade I complications, which was significantly more than the 8.3% of the TURP cases. In addition, Grade II complications were observed in 13.8% of the ThuFLEP group compared to 1.4% of the TURP group, with a statistically significant difference. Grade I complications consisted of fever and mild hematuria; Grade II complications consisted mainly of incontinence requiring medical management and pelvic floor exercises; and none of the patients suffered Grade III–V complications.
At the end of the 3-month follow-up, we found no significant difference between IPSS (9.25 ± 2.69 vs. 9.81 ± 2.93; P = 0.37) and Qmax (15.14 ± 1.58 mL/s vs. 15.14 ± 1.87 mL/s; P = 0.98) scores between the ThuFLEP and TURP groups [Table 1]. The decrease in IPSS compared to baseline was significant in both the ThuFLEP (IPSS: from 26.22 ± 12.53 to 9.25 ± 2.69 P < 0.0001) and TURP groups (25.67 ± 12–9.82 ± 2.94; P < 0.0001).
| Discussion|| |
EEP is an advanced form of transurethral prostatectomy with comparable outcomes to OSP, but with a better perioperative safety profile., EEP leads to quicker recovery than retropubic simple prostatectomy. A meta-analysis of 26 randomized controlled studies (RCTs) with more than 3000 patients performed by Zhang et al., indicated that enucleation had an advantage over TURP in terms of the duration of hospitalization, drop in Hb, rate of blood transfusion, and occurrence of Grade II/III and early complications. Although the AUA and EAU guidelines have stated that EEP is a prostate size-independent method, the latter underscored that it should be preferred for larger prostate glands. In the current study, we compared ThuFLEP with TURP in patients with a medium- to large-prostate BPH, but notably, the prostate volume was significantly greater in the ThuFLEP group.
In both groups, the greater preoperative IPSS and higher PVR volumes indicated LUTS, particularly due to excessive BOO. Further, a mean Qmax <10 mL/s indicates disease progression and the greater probability of benefit from surgical intervention.,
Of the 101 patients, 30% underwent ThuFLEP and the remaining underwent TURP. Despite the larger volume of prostates in the ThuFLEP group compared to the TURP group, there was no significant difference in the occurrence of hematuria. Moreover, the operative duration was significantly longer in the ThuFLEP group compared to the TURP group, which was ascribable to the ~9% larger prostate volume (92 cc vs. 84 cc) and methodology; such a small difference in duration (30 min) forms no impediments in a real-life setting., Despite the mean catheter duration being slightly longer in the ThuFLEP group than in the TURP group, it was <3 days in both groups; hence, the difference is unlikely to be clinically meaningful.
A prospective comparison of ThuFLEP with TURP demonstrated comparable efficacy in terms of improvement in voiding parameters and incidence of complications in patients with small-size prostate BPH (<80 cc). However, in the initial week after catheter removal, a greater number of patients suffered mild incontinence after ThuFLEP, although the majority of patients in both groups had recovered by the end of the month. The higher incontinence rate in the ThuFLEP group is possibly due to damage to the sphincter, a predictive risk factor for incontinence that has been demonstrated by Kobayashi et al. in a prospective study. Besides, the average prostate volume was ~105 g and the PVR was >415 mL, indicating that this particular patient subgroup likely had compromised detrusor function. This small study also suggested that unwarranted laser energy to control bleeding during the surgical procedure may increase the risk of UI and suggests optimization of hemostasis and laser application.
We observed no significant difference in the incidence of late complications between the two groups. However, the slightly greater but statistically insignificant incidence of retrograde ejaculation similar to SUI indicates a more complete removal of hyperplastic tissue with ThuFLEP. The higher incidence of retrograde ejaculation has also been reported by Enikeev et al., who also compared ThuFLEP with TURP but in patients with lower prostate volumes. In our study, according to the results of the Clavien–Dindo classification, ThuFLEP had significantly higher Grade I and II complications as compared to TURP, mainly due to high incontinence rates requiring medical management and pelvic floor exercises. We attribute the high incontinence rate to our early learning curve of “en bloc” enucleation of the prostate and the use of newer TFL technology for the enucleation procedure.
According to the QoL scores, significantly more patients felt comfortable with their postoperative state in the ThuFLEP group compared to the TURP group. The IPSS was similar in both groups at baseline and 3 months postoperatively, with nearly a 60% decrease in both ThuFLEP and TURP.
Thus, when EEP is considered in place of TURP in medium- to large-sized glands, ThuFLEP should be preferred to HoLEP due to better flexibility, reduced penetration, and faster development of efficiency within 20 surgeries compared to within 50–60 with HoLEP.,, The enucleation plane is also swiftly reestablished because of its ability to decrease carbonization with superior enucleation rates (42% faster).,,,,, Similar to the findings of Enikeev et al., in patients with giant glands, we found ThuFLEP to be a safe and highly efficacious treatment method for the management of moderate to large volume (>80 cc) glands.
The strength of our study lies in the fact that all of the procedures were performed by a single surgeon; hence, there is no potential source of bias regarding the intervention.
The limitations of our study include a short follow-up period. In addition, the levels of PSA should have been obtained and compared postoperatively as an indirect measure of complete removal of the hyperplastic tissue; however, the efficacy parameters do demonstrate and confirm complete removal in all patients in the ThuFLEP group. Moreover, the weight of the resected prostate tissue was not recorded. Although the decision regarding the choice of procedure was based on patient preference, we could have used ThuFLEP for a greater number of patients with larger prostate volumes (>80 cc). Finally, the urodynamic study was not performed for all patients, which may explain the exact etiology of incontinence after the surgery.
| Conclusion|| |
ThuFLEP based on the TFL is an emerging valuable EEP laser technology, which has been demonstrated to be equally efficacious as TURP in terms of improvement in IPSS and Qmax, particularly in patients with medium- to larger-size BPH, with significant improvement in QoL scores. However, in our early experience with this new technology, the overall complications of ThuFLEP are slightly higher compared to those of TURP in terms of incontinence.
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Conflicts of interest
There are no conflicts of interest.
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Abhay Dinkar Mahajan,
Sai Urology Hospital, 1, Vishal Nagar, Gajanan Mandir Road, Aurangabad - 431 005, Maharashtra
Source of Support: None, Conflict of Interest: None
[Table 1], [Table 2]