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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18-40
SponsorUniversity Hospital, Linkoeping

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Male patients aged 18-40 years

Disqualifiers

Scrotal pain or symptoms caused by trauma

Trial population

The study population consists of adult men aged 18-40 years presenting to participating Emergency Departments in Sweden with acute scrotal pain or scrotal symptoms suggestive of testicular torsion. Patients with trauma-related scrotal pain, symptom duration longer than one week, previous testicular surgery, or inability to provide informed consent are excluded. The study aims to evaluate the diagnostic accuracy of the TWIST score in a real-world adult ED population.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,000 Participants
are grouped into 1 trial group
Group A: Adult ED Patients with Acute Scrotal Pain

Trial outcomes

Primary outcomes

1

Diagnostic Accuracy of the TWIST Score (Low-Risk Group)

Number and proportion of adult patients with a low-risk TWIST score (0-2) who are confirmed not to have testicular torsion based on surgical exploration or follow-up within 30 days. This measures the sensitivity of the TWIST score to safely rule out torsion.

Time frame
Up to 30 days from ED visit

Secondary outcomes

1

Time to exploration

Time in hours from patient arrival in the Emergency Department to surgical intervention for suspected testicular torsion.

Time frame
30 days from ED visit
2

Testicular torsion

Number of testicular torsions found up to 30 days from ED visit

Time frame
30 days from inclusion
3

Pain at study inclusion

Pain at inclusion to the study measured by NRS

Time frame
Up to one hour from inclusion in the study.
4

Use of Ultrasound

If ultrasound was used during the Emergency Department visit

Time frame
Up to 48 hours from inclusion or ED discharge, whichever comes first

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Linkoeping

Lead sponsor

Linkoeping University

Collaborator