Prediction of the Severity of Female SUI by Measuring New Static and Dynamic Ultrasound Parameters of the Urethra (PRESIUS)

April 2, 2026 updated by: CMC Ambroise Paré
This study aims to evaluate the correlation of the ultrasonic functional length of the urethra and the incontinence urinary disorder (IUD). The goal is to predict the severity of the IU by measuring new static and dynamic ultrasound parameters of the urethra.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The urinary incontinence is a disorder which affects 25 to 45% of women. Nowadays, the role of urethral tissue in IUD is not explored although well viewed in perineal ultrasound. Our actual knowledge demonstrates that urodynamic ultrasound is reliable to establish the bladder neck mobility. And the posterior urethral wall mobility was often associated to the stress urinary incontinence. Two elements appeared to indicate the elasticity of the urethral environment: functional length urethral variation and urethral closure angle variation during Valsalva manoeuvres compared to rest. This study aims to evaluate the correlation of the ultrasonic functional length of the urethra and the incontinence urinary disorder for the purpose to predict the severity of this syndrome.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Neuilly-sur-Seine, France, 92200
        • CMC Hartmann
      • Paris, France, 75116
        • Centre Echographie Obstétricale

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • All patients aged over 18 years addressed to pelvic ultrasound

Exclusion Criteria:

  • Pregnant
  • Post-partum (under 6 month of childbirth)
  • Operated for a genitourinary prolapse or/and urinary incontinence
  • Utero vaginal symptomatic prolapse
  • Overactive bladder ± UI by
  • Dysuria
  • Severe deep pelvic endometriosis
  • Respiratory failure (Unable to perform the Valsalva manoeuvres)
  • History of pelvic cancer
  • Unable to understand the information communicated

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Continent women
Women with ICI-Q=0 Pelvic ultrasound / Urodynamic ultrasound
Other: Pelvic ultrasound / Urodynamic ultrasound
Gynecological consultation: calculating the score ICI-Q Ultrasound consultation: pelvic ultrasound Urodynamic ultrasound during a Valsalva manoeuvers
Experimental: Incontinent women
Women with ICI-Q≥1 Pelvic ultrasound / Urodynamic ultrasound
Other: Pelvic ultrasound / Urodynamic ultrasound
Gynecological consultation: calculating the score ICI-Q Ultrasound consultation: pelvic ultrasound Urodynamic ultrasound during a Valsalva manoeuvers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of ultrasonic urethral length
Time Frame: From 3 to 11 days after gynecological consultation
LT total length LF functional length LE funnel urethral length Measurement of the angle between proximal and distal urethra
From 3 to 11 days after gynecological consultation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CMC Ambroise Paré

Investigators

  • Principal Investigator: Georges BADER, MD, CMC Hartmann

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 2018

Primary Completion (Actual)

July 13, 2020

Study Completion (Actual)

July 13, 2020

Study Registration Dates

First Submitted

June 12, 2018

First Submitted That Met QC Criteria

June 12, 2018

First Posted (Actual)

June 21, 2018

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018/01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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