ABSTRACT
INTRODUCTION: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: This study provides evidence that the novel ST-01 treatment is safe and well-tolerated.
ABSTRACT
INTRODUCTION: This quality improvement study examined if a video-based resource could reduce delayed discharges after robotic prostatectomy while maintaining high levels of patient satisfaction. METHODS: From April 2018 to February 2020, all patients undergoing robotic-assisted radical prostatectomy (RARP) were asked to complete an anonymous survey evaluating their perioperative experience. The quality improvement (QI) intervention started in March 2019 with a series of six educational videos being shown to all patients. The videos were used to supplement postoperative instruction. The discharge times of all patients were obtained from The Ottawa Hospital Data Repositories. A run chart analysis was used to detect change in discharge time (outcome measure). Patient satisfaction (balancing measure) was analyzed using Chi-squared analysis and descriptive statistics. RESULTS: A total of 425 robotic prostatectomies (199 pre-intervention, 226 post-intervention) were available. Analysis of the run chart revealed non-random change favoring earlier discharge in the intervention group (p<0.05), with a pre-intervention late discharge rate of 64% and a post-intervention late discharge rate of 55%. A total of 140 surveys (59 pre-intervention, 81 post-intervention) assessing patient satisfaction were completed, corresponding with a response rate of 29.6% and 35.8%, respectively. Median score on a 10-point scale for overall satisfaction was equal between the intervention and non-intervention groups (9 [interquartile range (IQR 8-10) vs. 10 [IQR 8-10], p=0.92). CONCLUSIONS: Patient satisfaction with care and education was high for all patients and was not negatively impacted by this intervention. Video education tools may be one method to help improve the discharge process following RARP.
