Zimmermann Reinhold, Cumpanas Alin, Miclea Florin, Janetschek Günter
Department of Urology, Elisabethinen Hospital, University-affiliated Hospital, Linz, Austria.
Eur Urol. 2009 Sep;56(3):418-24. doi: 10.1016/j.eururo.2009.03.043. Epub 2009 Mar 25.
There is no sufficiently validated therapy for chronic pelvic pain syndrome (CPPS).
To investigate the effects of extracorporeal shock wave therapy (ESWT) in 60 patients suffering from CPPS.
DESIGN, SETTING, AND PARTICIPANTS: Sixty patients suffering from CPPS for at least 3 mo were investigated in two groups. Both groups were treated four times (once per week), each by 3000 impulses; group 2 was performed as a sham procedure. The investigation was designed as a placebo-controlled, prospectively randomised, double-blind phase 2 study. Standardised follow-up was performed 1, 4, and 12 wk after ESWT.
Low-energy-density ESWT was performed using a perineal approach without anaesthesia. In the placebo group, the same setting was used without shock wave energy transmission.
ESWT effects on pain, quality of life (QoL), erectile function (EF), and micturition were evaluated. The parameters were investigated using validated questionnaires (National Institutes of Health Chronic Prostatitis Symptom Index [NIH-CPSI], International Prostate Symptom Score [IPSS], International Index of Erectile Function [IIEF]) and the Visual Analog Scale (VAS) for pain evaluation.
All patients completed outpatient treatments and follow-ups without any problems. All 30 patients in the verum group showed statistically (highly) significant improvement of pain, QoL, and voiding conditions following ESWT in comparison to the placebo group, which experienced a continuous deterioration of the same parameters during the follow-up period. Perineal ESWT was easy and safe to perform without anaesthesia or any side-effects.
This is the first prospectively randomised, double-blind study to reveal perineal ESWT as a therapy option for CPPS with statistically significant effects in comparison to placebo. ESWT may in particular be interesting because of its easy and inexpensive application, the lack of any side-effects, and the potential for repetition of the treatment at any time.
对于慢性盆腔疼痛综合征（CPPS），尚无充分验证的治疗方法。
研究体外冲击波疗法（ESWT）对60例CPPS患者的疗效。
设计、场所和参与者：将60例患有CPPS至少3个月的患者分为两组进行研究。两组均接受4次治疗（每周1次），每次3000次脉冲；第2组采用假手术操作。该研究设计为安慰剂对照、前瞻性随机双盲2期研究。在ESWT后1周、4周和12周进行标准化随访。
采用会阴途径在无麻醉的情况下进行低能量密度ESWT。在安慰剂组中，使用相同的设置但不传输冲击波能量。
评估ESWT对疼痛、生活质量（QoL）、勃起功能（EF）和排尿的影响。使用经过验证的问卷（美国国立卫生研究院慢性前列腺炎症状指数[NIH-CPSI]、国际前列腺症状评分[IPSS]、国际勃起功能指数[IIEF]）和视觉模拟量表（VAS）对疼痛进行评估来研究这些参数。
所有患者均顺利完成门诊治疗及随访，无任何问题。与安慰剂组相比，治疗组的30例患者在ESWT后疼痛、QoL和排尿情况均有统计学意义（高度）显著改善，而安慰剂组在随访期间这些参数持续恶化。会阴ESWT操作简便、安全，无需麻醉且无任何副作用。
这是第一项前瞻性随机双盲研究，表明会阴ESWT是CPPS的一种治疗选择，与安慰剂相比具有统计学显著效果。ESWT因其操作简便、成本低廉、无任何副作用且可随时重复治疗，可能特别具有吸引力。
