Witherspoon Luke D E, Kesch Claudia, Schmitt Veronika, Boniface Graeme, Lundeen Colin, Nickel J Curtis, Paterson Ryan, Gleave Martin, Flannigan Ryan
Department of Urologic Sciences, University of British Columbia, Vancouver, BC, Canada.
Vancouver Prostate Centre, Vancouver, BC, Canada.
Can Urol Assoc J. 2023 Jul;17(7):E194-E201. doi: 10.5489/cuaj.8222.
Patients with chronic scrotal content pain (CSCP) lack effective, non-invasive treatment options. We aimed to determine the local and systemic safety, tolerability, pharmacokinetics (PK), and efficacy of a long-lasting local anesthetic in patients with CSCP.
This was a prospective, single-center, open-label, single-arm, phase 1, dose-escalating trial completed between October 2019 and March 2021. Twelve patients ≥19 years old with unilateral scrotal pain lasting ≥3 months reporting an average maximum pain score over seven days of ≥4 on a 0-10 numerical rating scale (NRS) were included. Patients underwent a test spermatic cord block and those reporting a decrease of ≥2 points were included. The investigational drug, ST-01 (sustained-release lidocaine polymer solution), is a long-acting injection of lidocaine around the spermatic cord. Subjects were provided a NRS dairy and recorded their NRS score until day 28. The Chronic Epididymitis Symptom Index (CESI) was completed on days 0, 7, 14, and 28. All patients underwent an examination and assessment for adverse events (AE) on days 0, 1, 7, 14, and 28. Exploratory statistical hypothesis testing was planned for this study due to its investigative nature.
There were no serious adverse events (SAEs) reported. All subjects reported at least one treatment-emergent adverse event (TEAE); 83% of related AEs were injection-site reactions consisting of swelling and bruising. NRS was reduced across all cohorts between baseline and end of study.
This study provides evidence that the novel ST-01 treatment is safe and well-tolerated.
慢性阴囊内容物疼痛（CSCP）患者缺乏有效的非侵入性治疗选择。我们旨在确定一种长效局部麻醉剂在CSCP患者中的局部和全身安全性、耐受性、药代动力学（PK）及疗效。
这是一项前瞻性、单中心、开放标签、单臂、1期剂量递增试验，于2019年10月至2021年3月完成。纳入12名年龄≥19岁、单侧阴囊疼痛持续≥3个月、在0-10数字评分量表（NRS）上报告7天平均最大疼痛评分≥4分的患者。患者接受了试验性精索阻滞，报告疼痛评分降低≥2分的患者被纳入。研究药物ST-01（缓释利多卡因聚合物溶液）是一种在精索周围长效注射的利多卡因。为受试者提供NRS日记，记录其NRS评分直至第28天。在第0、7、14和28天完成慢性附睾炎症状指数（CESI）评估。所有患者在第0、1、7、14和28天接受不良事件（AE）检查和评估。由于本研究具有探索性，因此计划进行探索性统计假设检验。
未报告严重不良事件（SAE）。所有受试者均报告至少一种治疗中出现的不良事件（TEAE）；83%的相关AE为注射部位反应，包括肿胀和瘀伤。在所有队列中，NRS在基线至研究结束时均有所降低。
本研究提供了证据表明新型ST-01治疗安全且耐受性良好。
