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Evaluation of the Diagnostic Performance of the Testicular Workup for Ischemia and Suspected Torsion (TWIST) Score for Assessing the Risk of Testicular Torsion in Adult Patients Presenting to the Emergency Department With Scrotal Pain - A Prospective Observational Study

NCT07499024 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2026-04-29

No results posted yet for this study

Summary

This prospective multicenter observational study aims to evaluate the diagnostic accuracy of the Testicular Workup for Ischemia and Suspected Torsion (TWIST) score in adult patients presenting with acute scrotal pain in Swedish Emergency Departments.

The TWIST score is a clinical decision tool originally validated in pediatric populations to stratify patients into low, intermediate, and high risk for testicular torsion. The study will include men aged 18-40 years presenting with scrotal pain or symptoms suggestive of torsion. Patients with scrotal trauma, symptom duration over one week, previous testicular surgery, or inability to give informed consent in Swedish will be excluded.

Participants' clinical findings will be recorded on a standardized form, and the TWIST score will be calculated. Management will follow standard clinical practice independently of the study. Primary outcome is the diagnostic accuracy of the TWIST score to rule out testicular torsion in low-risk patients (TWIST 0-2). Secondary outcomes include diagnosis of torsion within 30 days, time to surgery, patient-reported pain, number of Doppler ultrasounds performed, and the potential reduction in unnecessary imaging.

The study will be conducted at multiple Swedish sites, including Linköping University Hospital, under oversight by the Swedish Ethical Review Authority (Etikprövningsmyndigheten, decision number 2025-07400-01). The results aim to inform clinical practice by providing a validated decision-support tool for adult patients with suspected testicular torsion, potentially improving patient outcomes and resource utilization.

Conditions

  • Testicular Torsion
  • Acute Scrotum
  • Scrotal Pain

Sponsors & Collaborators

  • Linkoeping University

    collaborator OTHER_GOV

  • University Hospital, Linkoeping

    lead OTHER

Principal Investigators

  • Jens Wretborn, MD, PhD · Linkoeping University Hospital

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-01
Primary Completion
2028-01-31
Completion
2029-12-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07499024 on ClinicalTrials.gov