First Department of Urology, G. Gennimatas Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.
Prostate Cancer Prostatic Dis. 2021 Jun;24(2):370-379. doi: 10.1038/s41391-020-00284-2. Epub 2020 Sep 28.
Currently, there is no efficacious treatment method for chronic prostatitis type IIIb/chronic pelvic pain syndrome (CP/CPPS). Aim of the study was to investigate and compare the efficacy and safety of low-intensity shockwave therapy (LiST) vs. sham treatment in CP/CPPS patients.
Patients with CP/CPPS diagnosis were randomized in this prospective, sham-controlled, double-blind study either to the active groups (Group B, C) who received 5000 shockwaves per session with energy flux density 0.1 mJ/mm or to the sham group (Group A) who received 5000 shockwaves from a visually identical sham probe. All groups underwent six sessions (once/week). LiST effects on pain, micturition, quality of life (QoL), and erectile function were evaluated at 4, 12, and 24 weeks after treatment. The parameters were investigated using validated questionnaires. Uroflowmetry and post void residual calculation were performed at baseline and at 4- and 12-week FU visit. Prostate mpMRI and PSA measurement were performed at baseline and 12-week FU visit.
Overall, 45 men were randomized to the active (n = 30) and sham groups (n = 15). Regarding impact of LiST in National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) total, pain, and QoL subdomains scores a clear and persistent in all FU timepoints improvement was found compared to sham treatment. NIH-CPSI urinary subdomain, International Prostate Symptom Score [IPSS], PSA, and mpMRI-PIRADS scores did not differ between the two groups. The mean difference between the LiST and sham group in the change of the NIH-CPSI pain-domain score (Q1-4) from baseline to 12 weeks after final treatment which was 3.3 (95% CI, 1.8, 4.7). Perineal LiST was easy and safe to perform without anesthesia or any side-effects.
LiST seems to be a safe and effective treatment option for CP/CPPS, considerably improving pain and quality of life. Lack of any side-effects, and the potential for repetition make LiST a promising treatment choice for CP/CPPS patients.
目前，针对 IIIb 型慢性前列腺炎/慢性骨盆疼痛综合征（CP/CPPS）尚无有效的治疗方法。本研究旨在比较低强度冲击波治疗（LiST）与假治疗在 CP/CPPS 患者中的疗效和安全性。
采用前瞻性、假对照、双盲研究方法，将 CP/CPPS 患者随机分为主动治疗组（B 组、C 组）和假治疗组（A 组）。主动治疗组患者接受每次 5000 次冲击波治疗，能量通量密度为 0.1mJ/mm，假治疗组患者接受 5000 次外观相同的假探头冲击波治疗。所有组均接受 6 次治疗（每周 1 次）。治疗后 4、12 和 24 周评估 LiST 对疼痛、排尿、生活质量（QoL）和勃起功能的影响。采用经过验证的问卷评估参数。在基线和治疗后 4 周和 12 周的 FU 访视时进行尿流率和残余尿量计算。在基线和治疗后 12 周的 FU 访视时进行前列腺 mpMRI 和 PSA 测量。
共有 45 名男性被随机分配至主动治疗组（n=30）和假治疗组（n=15）。关于 LiST 对美国国立卫生研究院慢性前列腺炎症状指数（NIH-CPSI）总分、疼痛和生活质量子域评分的影响，与假治疗相比，在所有 FU 时间点均发现明显且持续的改善。NIH-CPSI 排尿子域、国际前列腺症状评分[IPSS]、PSA 和 mpMRI-PIRADS 评分在两组间无差异。LiST 组和假治疗组在末次治疗后 12 周 NIH-CPSI 疼痛域评分（Q1-4）的变化平均值为 3.3（95%CI，1.8，4.7）。会阴 LiST 易于实施，无需麻醉或任何副作用。
LiST 似乎是 CP/CPPS 的一种安全有效的治疗选择，可显著改善疼痛和生活质量。缺乏任何副作用以及可重复使用的特性使 LiST 成为 CP/CPPS 患者的一种有前途的治疗选择。
