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.
2023
N.A.
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11562/1112766
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