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

NCT ID: NCT03566121

Last Updated: 2020-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-10

Study Completion Date

2020-07-13

Brief Summary

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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

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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.

Conditions

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Incontinence, Urinary

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Continent women

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

Group Type OTHER

Pelvic ultrasound / Urodynamic ultrasound

Intervention Type OTHER

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

Incontinent women

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

Group Type EXPERIMENTAL

Pelvic ultrasound / Urodynamic ultrasound

Intervention Type OTHER

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

Interventions

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Pelvic ultrasound / Urodynamic ultrasound

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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CMC Ambroise Paré

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Georges BADER, MD

Role: PRINCIPAL_INVESTIGATOR

CMC Hartmann

Locations

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CMC Hartmann

Neuilly-sur-Seine, , France

Site Status

Centre Echographie Obstétricale

Paris, , France

Site Status

Countries

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France

Other Identifiers

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2018/01

Identifier Type: -

Identifier Source: org_study_id