NCT07499024 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
| NCT ID | NCT07499024 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Linkoeping |
| Condition | Testicular Torsion |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2026-02-01 |
| Primary Completion | 2028-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2026-02-01 with a primary completion date of 2028-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Male patients aged 18-40 years Presenting to the Emergency Department with acute scrotal pain or scrotal symptoms Suspicion of testicular torsion before clinical assessment Exclusion Criteria: * Scrotal pain or symptoms caused by trauma Symptom duration \> 1 week History of testicular surgery Inability to provide informed consent (e.g., language barrier or cognitive limitation)
Contact & Investigator
Jens Wretborn, MD, PhD
PRINCIPAL INVESTIGATOR
Linkoeping University Hospital
Frequently Asked Questions
Who can join the NCT07499024 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 40 Years, studying Testicular Torsion. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07499024 currently recruiting?
Yes, NCT07499024 is actively recruiting participants. Contact the research team at jens.wretborn@liu.se for enrollment information.
Where is the NCT07499024 trial being conducted?
This trial is being conducted at Linköping, Sweden.
Who is sponsoring the NCT07499024 clinical trial?
NCT07499024 is sponsored by University Hospital, Linkoeping. The principal investigator is Jens Wretborn, MD, PhD at Linkoeping University Hospital. The trial plans to enroll 1,000 participants.