Mykoniatis Ioannis, Pyrgidis Nikolaos, Kalyvianakis Dimitrios, Zilotis Filimon, Kapoteli Paraskevi, Fournaraki Agrippina, Hatzichristou Dimitrios
Department of Urology, Faculty of Medicine, School of Health Sciences, Aristotle University of Thessaloniki, Thessaloniki, Greece.
Prostate. 2021 Jun;81(9):499-507. doi: 10.1002/pros.24119. Epub 2021 Apr 30.
Despite encouraging results, the optimal low-intensity shockwave therapy (LiST) protocol in patients with chronic prostatitis/chronic pelvic pain syndrome (CPPS) remains unknown. We conducted a two-arm, parallel-group, randomized controlled trial aiming to compare the efficacy and safety of six LiST sessions applied once or twice weekly.
Fifty patients with CP/CPPS type IIIb were randomly assigned to six LiST sessions once (Group A, n = 25) or twice weekly (Group B, n = 25). Both groups followed the same treatment protocol in terms of LiST application, impulses (5000/session), energy flux density (0.096 mJ/mm ) and frequency (5 Hz). Subsequently, all participants were evaluated at 1 and 3 months after completion of LiST protocol.
At the follow-up evaluations, LiST significantly improved the National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) total, pain and quality of life scores, as well as the International Index of Erectile Function-Erectile Domain (IIEF-ED) in both groups (p < .001 for all measures). Comparing between the two groups, no significant differences were demonstrated in the NIH-CPSI total, pain, urinary and quality of life scores, as well as in the International Prostate Symptom Score, IIEF-ED, and LiST-induced pain at both follow-up evaluations. Accordingly, no adverse events and no dropouts were observed in both groups.
Six sessions of LiST applied once weekly for 6 weeks or twice weekly for 3 weeks seem to be equally safe and effective in patients with CP/CPPS. Nevertheless, further studies are necessary, since LiST gradually gains its place for the management of CP/CPPS.
尽管有令人鼓舞的结果,但慢性前列腺炎/慢性盆腔疼痛综合征(CPPS)患者的最佳低强度冲击波疗法(LiST)方案仍不明确。我们进行了一项双臂、平行组、随机对照试验,旨在比较每周进行一次或两次共六次LiST治疗的疗效和安全性。
50例IIIb型CP/CPPS患者被随机分为两组,A组(n = 25)每周进行一次共六次LiST治疗,B组(n = 25)每周进行两次共六次LiST治疗。两组在LiST应用、脉冲(每次5000)、能量通量密度(0.096 mJ/mm²)和频率(5 Hz)方面遵循相同的治疗方案。随后,在LiST方案完成后的1个月和3个月对所有参与者进行评估。
在随访评估中,LiST显著改善了两组的美国国立卫生研究院慢性前列腺炎症状指数(NIH-CPSI)总分、疼痛和生活质量评分,以及国际勃起功能指数-勃起功能领域(IIEF-ED)(所有测量指标p < 0.001)。两组之间比较,在两次随访评估中,NIH-CPSI总分、疼痛、排尿和生活质量评分,以及国际前列腺症状评分、IIEF-ED和LiST引起的疼痛方面均未显示出显著差异。因此,两组均未观察到不良事件和退出病例。
对于CP/CPPS患者,每周进行一次共6周或每周进行两次共3周的六次LiST治疗似乎同样安全有效。然而,由于LiST在CP/CPPS治疗中的地位逐渐确立,仍需要进一步研究。