Prediction of the Severity of Female SUI by Measuring New Static and Dynamic Ultrasound Parameters of the Urethra
PRESIUS
1 other identifier
interventional
50
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2018
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 12, 2018
CompletedFirst Posted
Study publicly available on registry
June 21, 2018
CompletedStudy Start
First participant enrolled
July 10, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 13, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 13, 2020
CompletedApril 8, 2026
April 1, 2026
2 years
June 12, 2018
April 2, 2026
Conditions
Outcome Measures
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
From 3 to 11 days after gynecological consultation
Study Arms (2)
Continent women
OTHERWomen with ICI-Q=0 Pelvic ultrasound / Urodynamic ultrasound
Incontinent women
EXPERIMENTALWomen with ICI-Q≥1 Pelvic ultrasound / Urodynamic ultrasound
Interventions
Gynecological consultation: calculating the score ICI-Q Ultrasound consultation: pelvic ultrasound Urodynamic ultrasound during a Valsalva manoeuvers
Eligibility Criteria
You may qualify if:
- All patients aged over 18 years addressed to pelvic ultrasound
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
CMC Hartmann
Neuilly-sur-Seine, 92200, France
Centre Echographie Obstétricale
Paris, 75116, France
Related Publications (1)
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.
PMID: 39716519RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Georges BADER, MD
CMC Hartmann
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2018
First Posted
June 21, 2018
Study Start
July 10, 2018
Primary Completion
July 13, 2020
Study Completion
July 13, 2020
Last Updated
April 8, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share