Testicular TorsionNCT07499024
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
An observational study of Testicular Torsion and Acute Scrotum, run by University Hospital, Linkoeping at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men only
- Conditions the study is for
- Testicular Torsion, Acute Scrotum, Scrotal Pain
- How many people
- 1,000 participants
- Where
- 1 siteSweden
- Study dates
- 1 Feb 2026to 31 Dec 2029
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Linköping University Hospital, ED
Linköping, Östergötland County, 58185
Jens Ragnar Wretborn, MD, PhD, +46, jens.wretborn@liu.se
About this study
Official title: 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
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.
Read more
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.
Read the detailed description
Acute scrotal pain is a common presentation in Emergency Departments, but the diagnosis of testicular torsion (TT) is relatively rare. Prompt identification is crucial because TT requires urgent surgical intervention to preserve testicular viability. Delays in diagnosis, particularly due to unnecessary imaging or non-standardized clinical assessment, may result in testicular loss.
The TWIST (Testicular Workup for Ischemia and Suspected Torsion) score is a clinical decision tool developed and validated in pediatric populations to stratify risk of TT based on five clinical features: testicular swelling, hard testis, high-riding testis, absent cremasteric reflex, and nausea/vomiting. Adult validation is limited, and no large-scale multicenter study has evaluated its performance in adult Emergency Department settings in Sweden.
This study will prospectively collect structured clinical data from adult patients aged 18-40 years presenting with scrotal pain at participating Swedish EDs. The TWIST score will be calculated from documented clinical findings. The study does not influence clinical management; patients will receive standard care, including imaging or surgical intervention as deemed appropriate by treating clinicians.
Primary objectives focus on the diagnostic accuracy of TWIST for ruling out TT in low-risk patients, while secondary objectives include assessment of the score in identifying high-risk patients, measurement of time to surgery, evaluation of pain scores, and analysis of imaging utilization. Data will also be linked to the Swedish Perioperative Register (SPOR) for outcomes such as surgery performed, complications, and final diagnoses.
The study is designed to evaluate whether structured use of TWIST can support evidence-based, standardized risk stratification in adults, potentially improving patient outcomes, streamlining resource use, and reducing unnecessary delays in diagnosis and treatment. Ethical oversight is provided by the Swedish Ethical Review Authority (Etikprövningsmyndigheten, decision 2025-07400-01).
- Conditions
- Testicular Torsion, Acute Scrotum, Scrotal Pain
- Keywords
- Testicular Torsion, Acute Scrotum, Testicular Workup for Ischemia and Suspected Torsion (TWIST)
- Medical subject headings
- Spermatic Cord Torsion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 30 days from ED visit
Secondary outcomes (4)
Time to exploration
Time in hours from patient arrival in the Emergency Department to surgical intervention for suspected testicular torsion.
Measured: 30 days from ED visit
Testicular torsion
Number of testicular torsions found up to 30 days from ED visit
Measured: 30 days from inclusion
Pain at study inclusion
Pain at inclusion to the study measured by NRS
Measured: Up to one hour from inclusion in the study.
Use of Ultrasound
If ultrasound was used during the Emergency Department visit
Measured: Up to 48 hours from inclusion or ED discharge, whichever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 Feb 2026
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Testicular TorsionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- University Hospital, Linkoeping
- Sponsor type
- University, hospital or other
- Collaborators
- Linkoeping University
- Responsible party
- Principal investigator, Daniel Wilhelms, University Hospital, Linkoeping
- Investigators
- Jens Wretborn, MD, PhD, Principal investigator, Linkoeping University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07499024
- Sponsor's protocol ID
- 2025-07400-01
- Other IDs
- 2025-07400-01, 2025
- Status last verified
- Apr 2026
- First submitted
- 6 Mar 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study will collect sensitive health data from adult patients with acute scrotal pain. Due to patient privacy and data protection regulations, individual participant-level data will not be shared outside the research team.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07499024
- Acronym / sponsor ID
- 2025-07400-01
- Conditions
- Testicular Torsion, Acute Scrotum, Scrotal Pain
- Keywords
- Testicular Torsion, Acute Scrotum, Testicular Workup for Ischemia and Suspected Torsion (TWIST)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University Hospital, LinkoepingUniversity, hospital or other
- Collaborators
- Linkoeping University
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Acute scrotal pain is a common presentation in Emergency Departments, but the diagnosis of testicular torsion (TT) is relatively rare. Prompt identification is crucial because TT requires urgent surgical intervention to preserve testicular viability. Delays in diagnosis, particularly due to unnecessary imaging or non-standardized clinical assessment, may result in testicular loss.
The TWIST (Testicular Workup for Ischemia and Suspected Torsion) score is a clinical decision tool developed and validated in pediatric populations to stratify risk of TT based on five clinical features: testicular swelling, hard testis, high-riding testis, absent cremasteric reflex, and nausea/vomiting. Adult validation is limited, and no large-scale multicenter study has evaluated its performance in adult Emergency Department settings in Sweden.
This study will prospectively collect structured clinical data from adult patients aged 18-40 years presenting with scrotal pain at participating Swedish EDs. The TWIST score will be calculated from documented clinical findings. The study does not influence clinical management; patients will receive standard care, including imaging or surgical intervention as deemed appropriate by treating clinicians.
Primary objectives focus on the diagnostic accuracy of TWIST for ruling out TT in low-risk patients, while secondary objectives include assessment of the score in identifying high-risk patients, measurement of time to surgery, evaluation of pain scores, and analysis of imaging utilization. Data will also be linked to the Swedish Perioperative Register (SPOR) for outcomes such as surgery performed, complications, and final diagnoses.
The study is designed to evaluate whether structured use of TWIST can support evidence-based, standardized risk stratification in adults, potentially improving patient outcomes, streamlining resource use, and reducing unnecessary delays in diagnosis and treatment. Ethical oversight is provided by the Swedish Ethical Review Authority (Etikprövningsmyndigheten, decision 2025-07400-01).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic Accuracy of the TWIST Score (Low-Risk Group)
Time frame: Up to 30 days from ED visit
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.
4 secondary outcomes
Time to exploration
Time frame: 30 days from ED visit
Testicular torsion
Time frame: 30 days from inclusion
Pain at study inclusion
Time frame: Up to one hour from inclusion in the study.
Use of Ultrasound
Time frame: Up to 48 hours from inclusion or ED discharge, whichever comes first
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. The study will collect sensitive health data from adult patients with acute scrotal pain. Due to patient privacy and data protection regulations, individual participant-level data will not be shared outside the research team.
Related trials for Testicular Torsion
RecruitingObservational study
Analysis of Factors Associated With Delayed Medical Consultation for Testicular Torsion Among Adolescents in the Haut-Rhin Department Between 2020 and 2025
Testicular Torsion, Adolescent
Not yet recruiting
Light-Based Monitoring (SR-NIRS) for Suspected Testicular Torsion in Children
Testicular Torsion, Healthy
Not yet recruiting
Thermal Imaging in the Diagnosis of Acute Testicular Pain
Testicular Diseases
Not yet recruitingObservational study
Deep Learning-Assisted Ultrasonic Diagnosis and Localization of Testicular Appendix Torsion
Testicular Appendix Torsion, Testicular Torsion
Not yet recruitingObservational study
Testicular Torsion Evaluation by ultraSonography Technic Imaging
Testicular Torsion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jens Wretborn, MD, PhD principal investigator
Linkoeping University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Testicular Torsion and Acute Scrotum, run by University Hospital, Linkoeping at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jens Wretborn, MD, PhD (+461030000, jens.wretborn@liu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Accuracy of the TWIST Score (Low-Risk Group) (time frame: Up to 30 days from ED visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.