INTRODUCTION AND OBJECTIVE: Transperineal interstitial laser ablation (TPLA) is among one of the latest ultra-minimally invasive technique to treat benign prostatic obstruction (BPO). No study investigated the actual rate of preservation of the ejaculatory function after TPLA, in comparison to the reference standard trans-urethral resection of prostate (TURP). We aimed to evaluate the reliability of TPLA in preserving the ejaculation compared to TURP. METHODS: In this single-center, prospective, randomized, open-label study, consecutive patients with indication to surgical treatment for BPO were enrolled between January 2020 and September 2021 (NCT04781049). Randomization defined two treatment arms: Group A: patients assigned to TPLA (experimental); Group B: patients assigned to TURP (standard). Primary endpoints included comparison of visual analogue scale (VAS), change in ejaculatory function (by EJ-MSHQ), and changes in sexual function (by IIEF-5) at 1 month after surgery. Secondary endpoints included ΔIPSS and ΔQoL, and Qmax improvement at 6 months. RESULTS: Fifty-one patients (26 TPLA versus 25 TURP) were analyzed. No differences were found in the perception of pain assessed by VAS. No differences in IIEF-5 score were found between groups. Distribution of ejaculatory function assessed by the EJ-MSHQ remained unmodified after TPLA (p=0.2) while a median 31% decrease in EJ-MSHQ score (IQR -67;-14%) was observed after TURP (p=0.01). Retrograde ejaculation was reported in one patient within the TPLA group (18 patients s/p TURP). A statistically significant difference between the treatment groups was found in terms of postoperative Qmax (15.2 (IQR 13.5–18.3) versus 26.0 (IQR 22.0–48.0) ml/s, TPLA versus TURP, p<0.001). Qmax was statistically significantly improved with respect to baseline after TPLA (%ΔQmax+42 (+24; +76), p<0.001). Both treatments significantly improved IPSS and QoL with respect to baseline, with TURP impacting more significantly (%ΔIPSS -35.9 (IQR -54.5; -1.3) versus -66.7 (-82.8; -46.7) and %ΔQoL -33.3 (-50; -8) versus -60.0 (IQR -80; -33), TPLA versus TURP, all p-values <0.03). CONCLUSIONS: TPLA allowed for maintaining ejaculation in 96% of the cases, confirming to be valid option in patients seeking for pairing the relief from BPO to the high probability of preserving ejaculatory function.
TRANSPERINEAL LASER ABLATION VERSUS TRANS-URETHRAL RESECTION OF PROSTATE FOR BENIGN PROSTATIC OBSTRUCTION: A RANDOMIZED CLINICAL TRIAL
Bertolo, R;
2023-01-01
Abstract
INTRODUCTION AND OBJECTIVE: Transperineal interstitial laser ablation (TPLA) is among one of the latest ultra-minimally invasive technique to treat benign prostatic obstruction (BPO). No study investigated the actual rate of preservation of the ejaculatory function after TPLA, in comparison to the reference standard trans-urethral resection of prostate (TURP). We aimed to evaluate the reliability of TPLA in preserving the ejaculation compared to TURP. METHODS: In this single-center, prospective, randomized, open-label study, consecutive patients with indication to surgical treatment for BPO were enrolled between January 2020 and September 2021 (NCT04781049). Randomization defined two treatment arms: Group A: patients assigned to TPLA (experimental); Group B: patients assigned to TURP (standard). Primary endpoints included comparison of visual analogue scale (VAS), change in ejaculatory function (by EJ-MSHQ), and changes in sexual function (by IIEF-5) at 1 month after surgery. Secondary endpoints included ΔIPSS and ΔQoL, and Qmax improvement at 6 months. RESULTS: Fifty-one patients (26 TPLA versus 25 TURP) were analyzed. No differences were found in the perception of pain assessed by VAS. No differences in IIEF-5 score were found between groups. Distribution of ejaculatory function assessed by the EJ-MSHQ remained unmodified after TPLA (p=0.2) while a median 31% decrease in EJ-MSHQ score (IQR -67;-14%) was observed after TURP (p=0.01). Retrograde ejaculation was reported in one patient within the TPLA group (18 patients s/p TURP). A statistically significant difference between the treatment groups was found in terms of postoperative Qmax (15.2 (IQR 13.5–18.3) versus 26.0 (IQR 22.0–48.0) ml/s, TPLA versus TURP, p<0.001). Qmax was statistically significantly improved with respect to baseline after TPLA (%ΔQmax+42 (+24; +76), p<0.001). Both treatments significantly improved IPSS and QoL with respect to baseline, with TURP impacting more significantly (%ΔIPSS -35.9 (IQR -54.5; -1.3) versus -66.7 (-82.8; -46.7) and %ΔQoL -33.3 (-50; -8) versus -60.0 (IQR -80; -33), TPLA versus TURP, all p-values <0.03). CONCLUSIONS: TPLA allowed for maintaining ejaculation in 96% of the cases, confirming to be valid option in patients seeking for pairing the relief from BPO to the high probability of preserving ejaculatory function.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.