CClinicalTrials.gg
CompletedNCT03566121PRESIUSUpdated Apr 8, 2026

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

An interventional study of Pelvic ultrasound / Urodynamic ultrasound in Incontinence, Urinary, sponsored by CMC Ambroise Paré. Completed at 2 sites in France. Open to female participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-08.

Sponsored by CMC Ambroise Paré · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Non-randomized
Ages
18 Years to 70 Years
Sex
Female
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Incontinence, Urinary
03

In context

Urinary Incontinence

1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.

This study's enrollment of 50 is below the median of 66 across 1,011 interventional studies indexed under Urinary Incontinence.

Browse Urinary Incontinence studies →

Lead sponsor

CMC Ambroise Paré is the lead sponsor of 47 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • All patients aged over 18 years addressed to pelvic ultrasound

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Other
    Continent women

    Women with ICI-Q=0 Pelvic ultrasound / Urodynamic ultrasound

    Other: Pelvic ultrasound / Urodynamic ultrasound

  • Experimental
    Incontinent women

    Women with ICI-Q≥1 Pelvic ultrasound / Urodynamic ultrasound

    Other: Pelvic ultrasound / Urodynamic ultrasound

Interventions

  • OtherPelvic ultrasound / Urodynamic ultrasound

    Gynecological consultation: calculating the score ICI-Q Ultrasound consultation: pelvic ultrasound Urodynamic ultrasound during a Valsalva manoeuvers

06

What researchers measure

Primary outcomes

  1. Measurement of ultrasonic urethral length

    LT total length LF functional length LE funnel urethral length Measurement of the angle between proximal and distal urethra

    Time frame: From 3 to 11 days after gynecological consultation

07

Study locations

2 sites
  • CMC Hartmann
    Neuilly-sur-Seine, 92200, France
  • Centre Echographie Obstétricale
    Paris, 75116, France
08

References and documents

Publications

  • Mal PA, Metzger U, Cornier E, Bloomfield J, Pizzoferrato AC, Bader G. PRESIUS, Predictive value of sonographic functional urethral length and urethral closure angle for the diagnosis of stress urinary incontinence. Fr J Urol. 2025 Apr;35(4):102848. doi: 10.1016/j.fjurol.2024.102848. Epub 2024 Dec 21. PubMed 39716519 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03566121
Lead sponsor
CMC Ambroise Paré
Responsible party
Sponsor
First posted
Jun 21, 2018
Start date
Jul 10, 2018
Primary completion
Jul 13, 2020
Completion
Jul 13, 2020
Last update
Apr 8, 2026

Study contacts

Georges BADER, MD
principal investigator · CMC Hartmann

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion