Treatment of chronic scrotal pain with sustained release lidocaine

A Randomized, Controlled Phase II Study of Repeat Dose ST-01 (Lidocaine Polymer Solution) vs Lidocaine for Spermatic Cord Block in Men With Chronic Scrotal Content Pain

This study is testing a new lidocaine treatment to see if it can help men with chronic scrotal pain feel better compared to standard care.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 63 (estimated)
• Ages: 19 Years and up
• Sex: Male
• Sponsor: Sustained Therapeutics Inc. (Industry-sponsored)
• Locations: 8 sites (Calgary, Alberta and 7 other locations)
• Trial ID: NCT05707208 on ClinicalTrials.gov

What this trial studies

This is a multi-center, phase 2, randomized, single-blind study comparing the effectiveness of repeat doses of ST-01, a sustained release lidocaine formulation, against standard care and 1% lidocaine HCL in men suffering from chronic scrotal content pain. Participants will be randomized into three groups to receive either ST-01 at two different dosages or the control treatment. The main goal is to evaluate the safety and efficacy of ST-01 in reducing pain over a series of injections administered every 28 days. Participants who are in the control group will have the option to switch to an ST-01 treatment arm after two treatments.

Who should consider this trial

Good fit: Ideal candidates are adult males aged 19 and older with chronic scrotal pain lasting more than three months and a positive response to a spermatic cord block.

Not a fit: Patients with non-nociceptive scrotal pain or those who do not respond to the spermatic cord block may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce chronic scrotal pain and improve the quality of life for affected patients.

How similar studies have performed: While this approach is novel in the context of chronic scrotal pain, similar studies using sustained release formulations for pain management have shown promising results.

Eligibility criteria

Inclusion Criteria:

1. Adult (≥ 19 years) male
2. Unilateral or bilateral scrotal pain lasting \> 3 months
3. Have nociceptive scrotal pain
4. Average daily maximum scrotal pain score over 7 days ≥ 4 on the 0-10 NRS (Appendix 2). Participants with bilateral scrotal pain must be able to distinguish one side with pain score ≥ 4 and the opposite side must have a maximum scrotal pain score of ≤ 3.0 at baseline.
5. Positive response to test spermatic cord block with 1% lidocaine (Lidocaine Hydrochloride Injection, USP, 1%, 10 mg/mL), defined as a decrease in pain score of at least 2 within 1 hour of injection
6. Baseline blood levels without clinically significant abnormalities including liver function tests (alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], gamma-glutamyl transferase \[GGT\], and alkaline phosphatase \[ALP\]) no greater than 50% above the upper limit of normal
7. If sexually active, is willing to use adequate birth control methods to prevent pregnancy over the course of the study

Exclusion Criteria:

1. Negative response to test spermatic cord block, defined as absence of a decrease in pain score of at least 2 within an hour of injection
2. Other pain generator site with NRS pain score ≥ 4 that interferes with evaluation of scrotal pain
3. History of allergic reaction to lidocaine or any component of ST-01
4. Any contraindication to local anesthesia with lidocaine (e.g., known hypersensitivity to anesthetics of the amide type; hypokalemia, complete heart block, anticoagulants (aspirin permitted), antiarrhythmic medication.)
5. Active infection involving the urinary tract or scrotum
6. Inability to give consent
7. Inability to follow up according to the protocol
8. Negative response to previous spermatic cord block
9. Any other condition that the investigator believes may interfere with the safety of the participant, study conduct, or interpretation of the data.

Where this trial is running

Calgary, Alberta and 7 other locations

• Prostate Cancer Centre - Rockyview Hospital — Calgary, Alberta, Canada (Recruiting)
• Kelowna General Hospital Clinical Research Department — Kelowna, British Columbia, Canada (Recruiting)
• Vancouver Prostate Centre — Vancouver, British Columbia, Canada (Recruiting)
• Men's Health Clinic Manitoba — Winnipeg, Manitoba, Canada (Recruiting)
• Jonathan Giddens Medicine Professional Corporation — Brampton, Ontario, Canada (Recruiting)
• The Fe/Male Health Centre — Oakville, Ontario, Canada (Recruiting)
• Mount Sinai Hospital - Men's Health Institute — Toronto, Ontario, Canada (Recruiting)
• THEO Medical — Montréal, Quebec, Canada (Recruiting)

Study contacts

• Study coordinator: Lesley Parker

Conditions Chronic Pain; Chronic Scrotal Content Pain; Chronic testicular pain; Chronic scrotal pain; Orchialgia; spermatic cord