MP37-14 A DOSE-ESCALATING PHASE I STUDY OF AN INJECTION OF LIDOCAINE PASTE FOR PROLONGED SPERMATIC CORD BLOCK IN MEN WITH CHRONIC SCROTAL CONTENT PAIN
Bibliographic record
Abstract
You have accessJournal of UrologyCME1 May 2022MP37-14 A DOSE-ESCALATING PHASE I STUDY OF AN INJECTION OF LIDOCAINE PASTE FOR PROLONGED SPERMATIC CORD BLOCK IN MEN WITH CHRONIC SCROTAL CONTENT PAIN Luke Witherspoon, Claudia Kesch, Veronika Schmitt, Graeme Boniface, Colin Lundeen, J. Curtis Nickel, Ryan Paterson, Martin Gleave, and Ryan Flannigan Luke WitherspoonLuke Witherspoon More articles by this author , Claudia KeschClaudia Kesch More articles by this author , Veronika SchmittVeronika Schmitt More articles by this author , Graeme BonifaceGraeme Boniface More articles by this author , Colin LundeenColin Lundeen More articles by this author , J. Curtis NickelJ. Curtis Nickel More articles by this author , Ryan PatersonRyan Paterson More articles by this author , Martin GleaveMartin Gleave More articles by this author , and Ryan FlanniganRyan Flannigan More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002591.14AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Spermatic cord block with local anesthetics provides pain relief in a subset of subjects with chronic scrotal content pain (CSCP), but relief is short-lived due to the rapid elimination of local anesthetics. This Phase I trial assessed the safety, tolerability, pharmacokinetics and efficacy of a long-acting formulation of lidocaine in patients with CSCP. METHODS: This was a prospective, single center, open label, single arm, Phase I dose-escalating trial. Male patients ≥19 years with unilateral scrotal pain lasting ≥3 months who reported an average daily maximum pain score over 7 days of ≥4 on a 0-10 numerical rating scale (NRS) were recruited. The investigational drug ST-01 (sustained-release lidocaine polymer solution for injection) is a long-acting lidocaine injected into the spermatic cord. ST-01 has two inactive ingredients, polyethylene glycol (PEG) and poly(lactic-co-glycolic acid) (PLGA) which slow the release of lidocaine. The study had 3 planned dose-escalating cohorts: cohort I: 2 mL of 140 mg/mL ST-01 (280 mg lidocaine); cohort II: 3 mL of 140 mg/mL ST-01 (420 mg lidocaine); cohort III: 4 mL of 140 mg/mL ST-01 (560 mg lidocaine). Subjects recorded their pain (NRS) three times a day on days 0–14, and once on days 15-27 of the study. The Chronic Epididymitis Symptom Index (CESI) was completed by patients on days 0, 7, 14, and 28 (end of study). RESULTS: Twenty subjects were screened, with 12 subjects being enrolled. NRS (mean, median) was reduced across all cohorts studied. Patients in cohort II (420 mg lidocaine) were identified via the dose escalation protocol. This group reported a baseline mean (median) NRS score of 5.3 (5), compared to an end of study score of 3.3 (3.5). Assessment of CESI score showed reduced scores over the study period with cohort II reporting a baseline mean (median) score of 19.8 (19) and an end of study value of 16.8 (17.5). Serum lidocaine concentrations were measured at 1 hour, 1 day and 7 days. Serum concentrations were similar across all cohorts at day 1 indicating only local release of the medication. There were no serious adverse events (SAE’s) reported in the study. All subjects reported at least one treatment-emergent adverse event (TEAE). Most TEAE’s were mild or moderate and related to bruising or swelling at the injection site. CONCLUSIONS: ST-01 was safely injected in 12 subjects suffering from CSCP with a promising efficacy signal. Source of Funding: This study was conducted with aid from the Vancouver Coastal Health Research Institute Translation and Innovation Award © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e614 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Luke Witherspoon More articles by this author Claudia Kesch More articles by this author Veronika Schmitt More articles by this author Graeme Boniface More articles by this author Colin Lundeen More articles by this author J. Curtis Nickel More articles by this author Ryan Paterson More articles by this author Martin Gleave More articles by this author Ryan Flannigan More articles by this author Expand All Advertisement PDF DownloadLoading ...
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.015 | 0.002 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".