Bryk Darren J, Murthy Prithvi B, Ericson Kyle J, Shoskes Daniel A
Cleveland Clinic Foundation, Glickman Urological and Kidney Institute, Cleveland, OH, USA.
University Hospitals Cleveland Medical Center, Department of Urology, Cleveland, OH, USA.
Transl Androl Urol. 2023 Feb 28;12(2):209-216. doi: 10.21037/tau-22-310. Epub 2023 Feb 6.
Low intensity shockwave therapy is an emerging treatment option for men with vasculogenic erectile dysfunction. Radial wave therapy (rWT), which differs from focused shockwave (fSWT) as it produces lower pressure waves with lower peak energy, is used to treat soft tissue and skin conditions and has some data to support its use in vasculogenic erectile dysfunction. There is limited data for the use of rWT for the treatment of erectile dysfunction after nerve-sparing (NS) radical prostatectomy. We report the first trial of rWT for penile rehabilitation after NS radical prostatectomy.
We performed a prospective, non-randomized, open-label trial. Men with good pre-operative erectile function who underwent a NS radical prostatectomy at our institution from 2018-2020 were considered for inclusion. We compared post-operative erectile function outcomes between the rWT (6 weekly treatments initiated approximately 2 weeks post-operatively) plus standard of care (phosphodiesterase type 5 inhibitor) arm and the non-sham controlled standard of care arm. The primary end point for our study was the proportion of men who returned to "near normal" erectile function, defined as IIEF-5 score ≥17 and erectile hardness score (EHS) ≥3, by 3 months post-operatively between the intervention and control arm. We also compared mean IIEF-5 scores and median EHSs between the arms.
One hundred and six patients were enrolled, of whom 73 patients had at least one reported survey response between 6 and 12 weeks post-operatively. Five (17%) and 11 (26%) patients recovered erectile function in the control and intervention arms, respectively, which was not a statistically significant difference (P=0.37). However, the intervention arm did have a significantly higher median EHS compared to the control arm (1 2, P=0.03). There were 4 adverse events related to pain during treatment and required only treatment intensity de-escalation.
rWT is safe but did not substantially improve the recovery of early erectile function after NS radical prostatectomy.
低强度冲击波疗法是治疗血管性勃起功能障碍男性的一种新兴治疗选择。径向波疗法（rWT）与聚焦冲击波（fSWT）不同，它产生的压力波较低，峰值能量也较低，用于治疗软组织和皮肤疾病，并且有一些数据支持其在血管性勃起功能障碍中的应用。关于rWT用于保留神经（NS）根治性前列腺切除术后勃起功能障碍治疗的数据有限。我们报告了首例rWT用于NS根治性前列腺切除术后阴茎康复的试验。
我们进行了一项前瞻性、非随机、开放标签试验。纳入2018年至2020年在我院接受NS根治性前列腺切除术且术前勃起功能良好的男性。我们比较了rWT组（术后约2周开始每周进行6次治疗）加标准治疗（5型磷酸二酯酶抑制剂）与非假对照标准治疗组的术后勃起功能结果。我们研究的主要终点是干预组和对照组术后3个月恢复到“接近正常”勃起功能的男性比例，“接近正常”勃起功能定义为国际勃起功能指数-5（IIEF-5）评分≥17且勃起硬度评分（EHS）≥3。我们还比较了两组之间的平均IIEF-5评分和中位EHS。
共纳入106例患者，其中73例患者在术后6至12周至少有一次报告的调查回复。对照组和干预组分别有5例（17%）和11例（26%）患者恢复勃起功能，差异无统计学意义（P=0.37）。然而，干预组的中位EHS明显高于对照组（1对2，P=0.03）。有4例与治疗期间疼痛相关的不良事件，仅需降低治疗强度。
rWT是安全的，但在NS根治性前列腺切除术后并未显著改善早期勃起功能的恢复。
