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

NCT07841821 | Completed

• 1 other identifier: 2025/31JUL/322
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

Brief 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 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

Keywords

Healthy Vollunteer; Urinary Retention; simplified ultrasound; bladder ultrasound

Outcome Measures

Primary Outcomes (1)

• 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.

  10 minutes

Secondary Outcomes (3)

• Ultrasound reproducibility

  10 minutes

• Ease of performing the ultrasound

  10 minutes

• Bladder volume versus urine volume

  10 minutes

Study Arms (1)

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.

Diagnostic Test: Bladder ultrasound

Interventions

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.

Bladder ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

MeSH Terms

Conditions

Urinary Retention

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 25, 2026
• Study Start: April 17, 2026
• Primary Completion: April 24, 2026
• Study Completion: July 13, 2026
• Last Updated: September 25, 2026

Record last verified: 2026-09

Locations

BE (1)