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 | Recruiting

• 1 other identifier: 2025-07400-01
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Testicular Torsion; Acute Scrotum; Scrotal Pain

Keywords

Testicular Torsion; Acute Scrotum; Testicular Workup for Ischemia and Suspected Torsion (TWIST)

Outcome Measures

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.

  Up to 30 days from ED visit

Secondary Outcomes (4)

• Time to exploration

  30 days from ED visit

• Testicular torsion

  30 days from inclusion

• Pain at study inclusion

  Up to one hour from inclusion in the study.

• Use of Ultrasound

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

Study Arms (1)

Adult ED Patients with Acute Scrotal Pain

All participants are assessed according to routine clinical care in the Emergency Department. The TWIST score is calculated from standard clinical findings but does not influence management; decisions regarding imaging or surgery follow usual clinical practice. Data on symptoms, TWIST score components, and outcomes (including surgical confirmation of testicular torsion) are collected prospectively.

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Linkoeping: lead
• Linkoeping University: collaborator

Study Sites (1)

Linköping University Hospital, ED

Linköping, Östergötland County, 58185, Sweden

RECRUITING

MeSH Terms

Conditions

Spermatic Cord Torsion

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Jens Wretborn, MD, PhD

  Linkoeping University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jens Wretborn, MD, PhD

CONTACT

+461030000; jens.wretborn@liu.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,PHD

Study Record Dates

• First Submitted: March 6, 2026
• First Posted: March 27, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)