At the end of November 2019, the report of the project OTCA17, titled “Lithium triborate (LBO) laser for photoselective vaporization of the prostate (PVP) in the treatment of benign prostatic hyperplasia (BPH)” was published on the website of the European Network for HTA (EUnetHTA).
The project was executed by the Italian National Agency for Regional Healthcare Services (AGENAS) together with the Emilia-Romagna Region (RER). The dedicated reviewers come from the Spanish Health Technology Assessment Agency (AETSA) and the Swiss Network for Health Technology Assessment (SNHTA).
Benign prostatic hyperplasia (BPH) is a condition that has adverse impacts on the lower urinary tract function because of the enlargement of the central transitional zone of the prostate. BPH is a progressive disease that, if left untreated, can lead to increased prostate volume, reduction in maximum urinary flow rate, and increased lower urinary tract symptoms (LUTS), resulting eventually in acute urinary retention (AUR), which is a medical emergency.
Lithium triborate (LBO) laser photoselective vaporization of the prostate (PVP) uses a high-power laser source to ablate and coagulate obstructive prostatic tissue. As the representative of the latest version of the technology, GreenLight XPS (GL-XPS), manufactured by Boston Scientific, the LBO laser system for PVP was assessed. The procedure involves passing the laser fiber through a cystoscope to reach the enlarged area of the prostate. The laser energy is then released, and vaporization is performed from the prostatic urethra towards the prostatic capsule. In the management of BPH, according to the prostate volume and the risk of bleeding sequelae. Specific reimbursement codes have been issued in Germany and Austria. In the other countries, the procedure is reimbursed under an umbrella code for transurethral prostatectomy, irrespective of the technology used.
The following procedures and technologies are comparators of GL-XPS: transurethral incision of the prostate (TUIP); transurethral resection of the prostate (TURP); open prostatectomy (OP); holmium laser enucleation of the prostate (HoLEP); bipolar enucleation; thulium laser vaporization of the prostate (ThuVAP); diode laser vaporization; and laser enucleation.
In order to rate the significance of each outcome, the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) approach was adopted. Clinical Effectiveness (EFF) and Safety (SAF) domains were based on a systematic review of evidence. Only articles published from the 1st of January 2009 to 13th November 2018 were considered. Searches were run on Embase, Medline and The Cochrane Library. Manual searches of the reference lists of relevant studies were also performed. Also, the following clinical trial databases were searched to identify the relevant clinical studies: clinicaltrials.gov, United Kingdom (UK) Clinical Trials Gateway, International Standard Randomised Controlled Trials Number (ISRCTN) Registry, European Union (EU) Clinical Trials Register and International Clinical Trials Registry Platform (ICTRP).
Results - clinical effectiveness:
- GL-XPS versus TURP: low-quality data suggested that at 6- (MD 1.2, 95% CI - 0.0-2.4 higher), 12- (MD 1.2 95% CI - 0.2-2.6) or 24-month follow-up (MD 1.0 95% CI - 0.5-2.5), GL-XPS is non-inferior to TURP in terms of reduction of symptoms based on the IPSS score (Bachmann A. et al., 2014, Bachmann A. et al., 2015, Thomas JA, 2016); low-quality data at 6 (MD 1.0 95% CI - 3.6-1.6) and 12 months (MD 1.8 95% CI - 4.3-0.7), and moderate-quality data at 24 months (MD 1.3 95% CI - 3.8-1.2) showed non-inferiority of GL-XPS versus TURP in improving Qmax and a similar reduction in PVR volume (MD 3.8 95% CI - 8.4-16.0), MD 9.4 95% CI - 3.1-21.9) and MD 10.7 95% CI - 3.5-24.9) correspondingly) (Bachmann A. et al., 2014, Bachmann A. et al., 2015, Thomas JA, 2016); low-quality data suggested a similar rate of dysuria between the two groups at 12 months (RR 0.81 95% CI - 0.45-1.45) and MD 1.3 95% CI - 3.3-0.7) (Bachmann A. et al., 2014, Bachmann A. et al., 2015, Thomas JA, 2016, Jovanović M, 2014); very low-quality data indicated a shorter hospital stay in the GL-XPS group than in TURP group. Duration of catheterization was shorter in the GL-XPS group than in the TURP group (Bachmann A. et al., 2014, Bachmann A. et al., 2015, Thomas JA, 2016, Jovanović M, 2014). No differences were found between GL-XPS and TURP regarding erectile function
- GL-XPS versus HoLEP: non-inferiority of GL-XPS versus HoLEP was found in the reduction of symptoms using the IPSS score (MD 1 95% CI - 0.96-2.96), higher Qmax improvement at 4- and 12-month follow-up (MD 17.1 lower (95% CI - 22.56-11.64), and shorter length of catheterization in the HoLEP group, whereas PVR volume reduction, rates of dysuria and length of hospital stay were similar between the two groups. No difference between GL-XPS and HoLEP was found regarding erectile function. However, the quality of evidence for all these outcomes was deficient (Elshal AM, 2015)
Results - health-related quality of life:
- GL-XPS versus TURP: no difference between the two strategies was found (Bachmann A. et al., 2014, Bachmann A. et al., 2015, Thomas JA, 2016)
- GL-XPS versus HoLEP: no difference between the two strategies was found (Elshal AM, 2015)
Results - patient satisfaction:
- GL-XPS versus TURP: at the end of the 24-month follow-up, a similar proportion of patients in the GL-XPS group and in TURP group would undergo the therapy again and would recommend their treatment (Bachmann A. et al., 2014, Bachmann A. et al., 2015, Thomas JA, 2016)
- GL-XPS versus HoLEP: no evidence was found to answer this research question (Elshal AM, 2015)
Results - safety:
- GL-XPS versus TURP: At 30-day follow-up, low-quality data showed that the patients in the GL-XPS group had a significantly lower rate of re-intervention compared with patients in the TURP group (RR 0.30 95% CI - 0.10-0.90), but this difference was not maintained at 6- (RR 0.71 95% CI - 0.36-1.38), 12- (RR 0.78 95% CI - 0.42-1.44) and 24-month (RR 1.37 95% CI - 0.63-2.97) follow-up. Patients in the GL-XPS group had a lower risk of being transfused during the surgical procedure compared with patients in the TURP group. Low-quality data did not show any difference between the two strategies regarding urinary incontinence (at 6-, 12- or 24-month follow-up), strictures (at 12-month follow-up), irritative symptoms, including pain and discomfort, urinary tract infections (UTIs) and urinary retention (at 6-, 12- or 24-month follow-up), erectile dysfunction (at 12- or 24-month follow-up), procedural and postoperative bleeding (at 6-, 12- or 24-month follow-up). No evidence of differences was found between the GL-XPS and TURP groups regarding TURP syndrome and rate of capsular perforation (Elshal AM, 2015)
- GL-XPS versus HoLEP: there was very low-quality evidence available from the only study (Elshal AM, 2015) and suggested no difference between the two strategies at 12-month follow-up: re-intervention rate; urinary incontinence; stricture occurrence; UTI occurrence; and urinary retention. There was no evidence for differences in procedural transfusions, postoperative hematuria, capsular perforation, and conversion rate to monopolar TURP for hemostasis or because of residual prostate tissue in the GL-XPS versus HoLEP groups.
Conclusions:
- No good-quality evidence supporting most of the claimed benefits of GL-XPS versus its comparators was found
- When comparing GL-XPS with TURP, the quality of evidence was judged as moderate according to GRADE for the outcomes Qmax and PVR improvement. This suggests that, for these two outcomes, GL-XPS is non-inferior to TURP
- Therefore, further research is needed. In particular, although evidence for men with a prostate volume between 30 ml and 80 ml and men with prostate volume >80 ml was available, no studies reporting specifically on men with prostate volume <30 ml and men at risk of bleeding sequelae which cannot stop anticoagulation therapy were identified. Follow-up exceeding 24 months should be considered for a proper assessment of some of the outcomes (especially re-intervention rate) and, thus, multicentric multi-operator study designs with appropriate sample sizes are awaited
The full report in English can be found here.
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