Schiellerup Nicolai Skov, Kobberø Hanne, Andersen Karin, Poulsen Charlotte Aaberg, Poulsen Mads Hvid
Department of Urology Odense University Hospital Odense Denmark.
BJUI Compass. 2024 Apr 24;5(6):541-547. doi: 10.1002/bco2.349. eCollection 2024 Jun.
Chronic scrotal pain is a common condition with a prevalence of 2.5-4.8% in male outpatients. Up to 40% of these patients report depressive symptoms and many feel isolated. Minimal invasive treatment is lacking, while spermatic cord injections of Botox® (BTX) have been proposed to offer long-term pain relief.
This research protocol comprises a prospective multicentre, randomized, double-blinded clinical trial drawing patients from other urological departments in the region of Southern Denmark.
The primary end point will be reduction in pain evaluated by visual analogue score for pain at 3 months. Secondary end point will be length of effect of BTX injections along with changes in quality of life.
The study will include 50 patients for randomization to either spermatic cord block with 100 IE BTX or sterile saline. All patients will prior to randomization undergo physical examination and will be asked to fulfil multiple questionnaires regarding pain and impact in daily life, that is, (1) visual analogue score for pain, (2) quality of life (EQ-5D-5L), (3) Chronic Prostatitis Symptom Index (NIH-CPSI), (4) ICD-10 depression questionnaire (MDI), (5) Likert global assessment scale, and (6) International Index of Erectile Function questionnaire. Physical examination and fulfilment of the questionnaires will be repeated multiple times throughout the study period of 12 weeks. After this time point, patients will be unblinded, and the control arm will be given the opportunity of cross-over.
慢性阴囊疼痛是一种常见病症，在男性门诊患者中的患病率为2.5%-4.8%。这些患者中高达40%报告有抑郁症状，许多人感到孤立。目前缺乏微创治疗方法，而有人提出精索注射肉毒杆菌毒素（BTX）可提供长期疼痛缓解。
本研究方案包括一项前瞻性多中心、随机、双盲临床试验，从丹麦南部地区的其他泌尿外科招募患者。
主要终点指标为3个月时通过视觉模拟评分法评估的疼痛减轻情况。次要终点指标为BTX注射的效果持续时间以及生活质量的变化。
该研究将纳入50例患者，随机分为接受100国际单位BTX精索阻滞或无菌生理盐水注射两组。所有患者在随机分组前均需接受体格检查，并被要求填写多份关于疼痛及对日常生活影响的问卷，即：（1）疼痛视觉模拟评分；（2）生活质量（EQ-5D-5L）；（3）慢性前列腺炎症状指数（NIH-CPSI）；（4）ICD-10抑郁问卷（MDI）；（5）李克特整体评估量表；（6）国际勃起功能指数问卷。在为期12周的研究期间，将多次重复体格检查和问卷填写。在这个时间点之后，患者将不再设盲，对照组将有机会进行交叉治疗。
