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OpenTrials
Completed

NCT Number: NCT07841821

Identification of Urinary Retention by Simplified Ultrasound: Diagnostic Without Volumetric Measurements

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy adult volunteers
  • Informed consent read and signed by the healthy volunteer

Exclusion criteria

  • 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.

Treatment and study plan

Bladder ultrasound

Diagnostic 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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Ultrasound reproducibility

    Time frame: 10 minutes

    Bladder ultrasound is performed on more than 100 healthy volunteers by three different nurses and three different physicians

  2. Ease of performing the ultrasound

    Time frame: 10 minutes

    The three nurses performing the ultrasound must complete a questionnaire regarding the ease of performing the procedure.

  3. Bladder volume versus urine volume

    Time frame: 10 minutes

    The bladder volume measured by ultrasound is compared to the urine volume after voiding.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Acronym: GUS

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 25, 2026
Registry last updated
Sep 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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