Urinary RetentionGUSNCT07841821
Identification of Urinary Retention by Simplified Ultrasound: Diagnostic Without Volumetric Measurements
A study testing Bladder ultrasound in people with Urinary Retention and Healthy Vollunteer, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
Urinary retention is a urological emergency that requires prompt management to prevent complications such as acute kidney injury or bladder rupture. Currently, diagnosis is based on clinical examination, sometimes supplemented by a bladder scanner (a device used to measure bladder volume) or by a more detailed… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Urinary Retention, Healthy Vollunteer
- What is being tested?
- Bladder ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteBelgium
- Study dates
- 17 Apr 2026to 13 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adult volunteers
- Informed consent read and signed by the healthy volunteer
Who cannot join
- Healthy volunteer refusing to undergo the ultrasound.
- Performance of the suprapubic ultrasound is impossible.
- Healthy volunteer unable to understand any of the languages used for the consent process.
Trial locations and contacts
1 site in 1 country.
About this study
Urinary retention is a urological emergency that requires prompt management to prevent complications such as acute kidney injury or bladder rupture. Currently, diagnosis is based on clinical examination, sometimes supplemented by a bladder scanner (a device used to measure bladder volume) or by a more detailed ultrasound examination with measurement of bladder volume. A bladder volume greater than 400 mL (urinary bladder distension), combined with anuria, dysuria, or suprapubic pain, is diagnostic of urinary retention.
The aim of this prospective study protocol is to determine whether simple visualization of the bladder using an ultrasound probe placed between the umbilicus and the pubic bone, performed by trained nurses, can reliably diagnose urinary bladder distension (bladder volume greater than 400 mL). If this hypothesis is confirmed, this approach could enable a simple and rapid diagnosis, thereby facilitating earlier treatment of bladder distension secondary to urinary retention.
- Conditions
- Urinary Retention, Healthy Vollunteer
- Being tested
- Bladder ultrasound
- Keywords
- Healthy Vollunteer, Urinary Retention, simplified ultrasound, bladder ultrasound
- Medical subject headings
- Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bladder ultrasoundDiagnostic test
The procedure involves a simplified bladder ultrasound performed by emergency nurses, followed by an ultrasound performed by the investigating physicians that allows for a complete measurement of the bladder.
| Study group | Role | What they receive |
|---|---|---|
| Bladder ultrasound | Other | The investigator nurse will place an ultrasound probe in the suprapubic position, transversely and perpendicular to the skin, in the healthy volunteer. Simple visualization of the bladder will be recorded as either visible or not visible. The investigator nurse will then assess whether the examination is considered easy or difficult.
A measurement of bladder volume (width, length, and height) will subsequently be performed by a physician investigator trained in ultrasound.
The healthy volunteer will then urinate into a graduated container. An ultrasound examination will be performed again to assess whether any post-void residual urine volume is present. Receives: Diagnostic Test: Bladder ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of simplified ultrasound
The primary objective of this study is to measure bladder volume in healthy volunteers using simplified ultrasound performed by nurses, in order to evaluate the diagnostic performance of bladder ultrasound. Bladder distension (volume ranging from 300 cc to >500 cc) is a sign of urinary retention. Diagnosis typically relies on comprehensive volumetric bladder ultrasound performed by physicians. In the absence of volumetric ultrasound, if urinary retention is suspected, urinary catheterization (an invasive procedure) is sometimes performed "blindly" for diagnostic purposes to allow for urine drainage. In this context, simplified bladder ultrasound performed by nurses could reduce diagnostic time and patient discomfort.
Measured: 10 minutes
Secondary outcomes (3)
Ultrasound reproducibility
Bladder ultrasound is performed on more than 100 healthy volunteers by three different nurses and three different physicians
Measured: 10 minutes
Ease of performing the ultrasound
The three nurses performing the ultrasound must complete a questionnaire regarding the ease of performing the procedure.
Measured: 10 minutes
Bladder volume versus urine volume
The bladder volume measured by ultrasound is compared to the urine volume after voiding.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start17 Apr 2026
- Primary completion24 Apr 2026
- Study completion13 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary RetentionStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07841821
- Sponsor's protocol ID
- 2025/31JUL/322
- Acronym
- GUS
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Urinary Retention by Simplified Ultrasound: Diagnostic Without Volumetric Measurements
- ClinicalTrials.gov ID
- NCT07841821
- Acronym / sponsor ID
- GUS / 2025/31JUL/322
- Conditions
- Urinary Retention, Healthy Vollunteer
- Keywords
- Healthy Vollunteer, Urinary Retention, simplified ultrasound, bladder ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 17 Apr 2026 (actual)
- Primary completion
- 24 Apr 2026 (actual)
- Study completion
- 13 Jul 2026 (actual)
- First posted
- 25 Sep 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.
Urinary retention is a urological emergency that requires prompt management to prevent complications such as acute kidney injury or bladder rupture. Currently, diagnosis is based on clinical examination, sometimes supplemented by a bladder scanner (a device used to measure bladder volume) or by a more detailed ultrasound examination with measurement of bladder volume. A bladder volume greater than 400 mL (urinary bladder distension), combined with anuria, dysuria, or suprapubic pain, is diagnostic of urinary retention.
The aim of this prospective study protocol is to determine whether simple visualization of the bladder using an ultrasound probe placed between the umbilicus and the pubic bone, performed by trained nurses, can reliably diagnose urinary bladder distension (bladder volume greater than 400 mL). If this hypothesis is confirmed, this approach could enable a simple and rapid diagnosis, thereby facilitating earlier treatment of bladder distension secondary to urinary retention.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bladder ultrasound | Other | Diagnostic Test: Bladder ultrasoundThe investigator nurse will place an ultrasound probe in the suprapubic position, transversely and perpendicular to the skin, in the healthy volunteer. Simple visualization of the bladder will be recorded as either visible or not visible. The investigator nurse will then assess whether the examination is considered easy or difficult. A measurement of bladder volume (width, length, and height) will subsequently be performed by a physician investigator trained in ultrasound. The healthy volunteer will then urinate into a graduated container. An ultrasound examination will be performed again to assess whether any post-void residual urine volume is present. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy adult volunteers
- Informed consent read and signed by the healthy volunteer
Key exclusion criteria (3 listed)
- Healthy volunteer refusing to undergo the ultrasound.
- Performance of the suprapubic ultrasound is impossible.
- Healthy volunteer unable to understand any of the languages used for the consent process.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bladder ultrasoundThe procedure involves a simplified bladder ultrasound performed by emergency nurses, followed by an ultrasound performed by the investigating physicians that allows for a complete measurement of the bladder. | Diagnostic test | Bladder ultrasound |
Primary outcome
Diagnostic performance of simplified ultrasound
Time frame: 10 minutes
The primary objective of this study is to measure bladder volume in healthy volunteers using simplified ultrasound performed by nurses, in order to evaluate the diagnostic performance of bladder ultrasound. Bladder distension (volume ranging from 300 cc to >500 cc) is a sign of urinary retention. Diagnosis typically relies on comprehensive volumetric bladder ultrasound performed by physicians. In the absence of volumetric ultrasound, if urinary retention is suspected, urinary catheterization (an invasive procedure) is sometimes performed "blindly" for diagnostic purposes to allow for urine drainage. In this context, simplified bladder ultrasound performed by nurses could reduce diagnostic time and patient discomfort.
3 secondary outcomes
Ultrasound reproducibility
Time frame: 10 minutes
Ease of performing the ultrasound
Time frame: 10 minutes
Bladder volume versus urine volume
Time frame: 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
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Pelvic Health Electrically Evoked Recording (PEER) 2 Study
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bladder ultrasound in people with Urinary Retention and Healthy Vollunteer, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 25 Sep 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance of simplified ultrasound (time frame: 10 minutes). 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 25 Sep 2026.