Light-Based Monitoring for Testicular Torsion

(SR-NIRS Trial)

This trial tests a new method to assess blood flow and oxygen levels in the testicles using a non-invasive light-based test called SR-NIRS. It focuses on boys with no testicular problems or those experiencing sudden scrotal pain. The goal is to determine if SR-NIRS can provide reliable information to aid in diagnosing conditions like testicular torsion, where the blood supply to the testicle becomes twisted. Boys visiting a urology clinic for non-testicular issues or sudden scrotal pain may be suitable for this trial. During a brief, one-time visit, participants will have a small probe placed on the skin over their testicle and thigh. As an unphased trial, this study offers a unique opportunity to contribute to innovative diagnostic methods that could enhance future care.

The trial information does not specify whether you need to stop taking your current medications. Since the study involves a non-invasive test and does not affect diagnosis or treatment, it's likely you can continue your medications, but please confirm with the study team.

Research has shown that Spatially Resolved Near-Infrared Spectroscopy (SR-NIRS) is generally safe and well-tolerated. A small initial study found SR-NIRS to be a non-invasive, easy, and safe method for diagnosing twisted testicles in adults, suggesting similar safety for children.

In another case, SR-NIRS successfully diagnosed a 14-month-old boy suspected of having twisted testicles, with no reported side effects. This technology assesses blood flow and oxygen levels in the testicles without causing harm.

Researchers are excited about the Light-Based Monitoring for Testicular Torsion trial because it explores a new, non-invasive technique called SR-NIRS (Spatially Resolved Near-Infrared Spectroscopy) for diagnosing testicular torsion. Unlike current diagnostic methods, which often involve ultrasound or surgical exploration, SR-NIRS aims to detect blood flow changes using light-based signals. This approach could lead to faster and more accurate diagnosis, reducing the need for invasive procedures and potentially saving the affected testis by allowing for quicker intervention. By providing real-time insights into the condition of both the affected and unaffected testis, this method could revolutionize how testicular torsion is assessed and managed.

This trial will use Spatially Resolved Near-Infrared Spectroscopy (SR-NIRS) to monitor blood flow and oxygen levels in the testicles. Participants in the "Healthy Controls" arm will undergo SR-NIRS signal acquisition from the testis and ipsilateral upper thigh. Meanwhile, participants in the "Testicular Torsion Cases" arm will have SR-NIRS signal recording from the affected testis, contralateral testis, and upper thigh. Studies have shown that SR-NIRS can quickly detect low oxygen levels, which occur in testicular torsion. This is crucial because testicular torsion can cause permanent damage if not treated quickly. Although some studies suggest that NIRS might not always clearly diagnose torsion, it can help identify low oxygen levels in the testicles. The researchers hope that SR-NIRS could reduce the need for more invasive tests like surgery or ultrasound.¹²³⁶⁷