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Treatment of LUTS Secondary to BPH While Preserving Sexual Function: Randomized Controlled Study of Prostatic Urethral Lift

机译:保留性功能的同时治疗BPH继发性LUTS:前列腺尿道举升的随机对照研究

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Introduction: We analyzed data obtained from a randomized controlled blinded study of the prostatic urethral lift (PUL) to evaluate the sexual side effects of this novel treatment. Aims: We sought to determine whether PUL, when conducted in a randomized study, significantly improved lower urinary tract symptoms (LUTS) and urinary flow rate while preserving sexual function. Methods: Men ≥50 years with prostates 30-80 cc, International Prostate Symptom Score (IPSS)>12, and peak urinary flow rate (Qmax) ≤12ml/s were randomized 2:1 between PUL and sham. Sexual activity was not an inclusion criterion. In PUL, permanent transprostatic implants are placed to retract encroaching lateral lobes and open the prostatic fossa. Sham entailed rigid cystoscopy with sounds to mimic PUL and a blinding screen. Main Outcome Measures: Blinded groups were compared at 3 months and active arm then followed to 12 months for LUTS with IPSS and for sexual function with sexual health inventory for men (SHIM) and Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EjD). Subjects were censored from primary sexual function analysis if they had baseline SHIM<5 at enrollment. Secondary stratified analysis by erectile dysfunction (ED) severity was conducted. Results: There was no evidence of degradation in erectile or ejaculatory function after PUL. SHIM and MSHQ-EjD scores were not different from control at 3 months but were modestly improved and statistically different from baseline at 1 year. Ejaculatory bother score was most improved with a 40% improvement over baseline. Twelve-month SHIM was significantly improved from baseline for men entering the study with severe ED, P=0.016. IPSS and Qmax were significantly superior to both control at 3 months and baseline at 1 year. There was no instance of de novo sustained anejaculation or ED over the course of the study. Conclusions: The PUL improves LUTS and urinary flow while preserving erectile and ejaculatory function.
机译:简介:我们分析了从前列腺尿道抬高(PUL)的随机对照盲研究中获得的数据,以评估这种新疗法的性副作用。目的:我们试图确定在一项随机研究中进行PUL时是否在保持性功能的同时,显着改善了下尿路症状(LUTS)和尿流率。方法:将PUL和假手术之间2:1的男性≥50岁,前列腺30-80 cc,国际前列腺症状评分(IPSS)> 12,尿峰值流速(Qmax)≤12ml/ s。性活动不是一项纳入标准。在PUL中,放置永久性前列腺前列腺植入物以缩回侵犯的侧叶并打开前列腺窝。假手术需要进行硬性膀胱镜检查,并具有模仿PUL和盲屏的声音。主要结果指标:比较盲人组在3个月时的活动手臂,然后随访12个月的LUTS伴IPSS和性功能,并附有男性性健康清单(SHIM)和男性射精功能性健康问卷(MSHQ-EjD)。如果受试者入组时基线SHIM <5,则从主要性功能分析中对受试者进行检查。进行了根据勃起功能障碍(ED)严重程度的二级分层分析。结果:没有证据表明PUL后勃起或射精功能下降。在3个月时,SHIM和MSHQ-EjD评分与对照组无差异,但在1年时有所改善,且与基线相比有统计学差异。射精困扰评分改善最大,较基线改善40%。与严重ED进入研究的男性相比,十二个月SHIM较基线明显改善,P = 0.016。 IPSS和Qmax均显着优于3个月的对照和1年的基线。在研究过程中,没有从头持续射精或ED的情况。结论:PUL可改善LUTS和尿流,同时保持勃起和射精功能。

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