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

Primary Purpose

Incontinence, Urinary

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Pelvic ultrasound / Urodynamic ultrasound
Sponsored by
CMC Ambroise Paré
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Incontinence, Urinary

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • CMC Hartmann
  • Centre Echographie Obstétricale

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Continent women

Incontinent women

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 12, 2018
Last Updated
November 9, 2020
Sponsor
CMC Ambroise Paré
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1. Study Identification

Unique Protocol Identification Number
NCT03566121
Brief Title
Prediction of the Severity of Female SUI by Measuring New Static and Dynamic Ultrasound Parameters of the Urethra
Acronym
PRESIUS
Official Title
Prediction of the Severity of Female SUI by Measuring New Static and Dynamic Ultrasound Parameters of the Urethra
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
July 10, 2018 (Actual)
Primary Completion Date
July 13, 2020 (Actual)
Study Completion Date
July 13, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CMC Ambroise Paré

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Incontinence, Urinary

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Continent women
Arm Type
Other
Arm Description
Women with ICI-Q=0 Pelvic ultrasound / Urodynamic ultrasound
Arm Title
Incontinent women
Arm Type
Experimental
Arm Description
Women with ICI-Q≥1 Pelvic ultrasound / Urodynamic ultrasound
Intervention Type
Other
Intervention Name(s)
Pelvic ultrasound / Urodynamic ultrasound
Intervention Description
Gynecological consultation: calculating the score ICI-Q Ultrasound consultation: pelvic ultrasound Urodynamic ultrasound during a Valsalva manoeuvers
Primary Outcome Measure Information:
Title
Measurement of ultrasonic urethral length
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Georges BADER, MD
Organizational Affiliation
CMC Hartmann
Official's Role
Principal Investigator
Facility Information:
Facility Name
CMC Hartmann
City
Neuilly-sur-Seine
ZIP/Postal Code
92200
Country
France
Facility Name
Centre Echographie Obstétricale
City
Paris
ZIP/Postal Code
75116
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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