Incontinence, UrinaryPRESIUSNCT03566121
Prediction of the Severity of Female SUI by Measuring New Static and Dynamic Ultrasound Parameters of the Urethra
A study testing Pelvic ultrasound / Urodynamic ultrasound in people with Incontinence, Urinary, run by CMC Ambroise Paré at 2 sites in France.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Incontinence, Urinary
- What is being tested?
- Pelvic ultrasound / Urodynamic ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesFrance
- Study dates
- 10 Jul 2018to 13 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients aged over 18 years addressed to pelvic ultrasound
Who cannot join
- 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
Show all 10Show fewer
- Severe deep pelvic endometriosis
- Respiratory failure (Unable to perform the Valsalva manoeuvres)
- History of pelvic cancer
- Unable to understand the information communicated
Trial locations and contacts
2 sites in 1 country.
France2 sites
CMC Hartmann
Neuilly-sur-Seine, 92200
Centre Echographie Obstétricale
Paris, 75116
About this study
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.
- Conditions
- Incontinence, Urinary
- Being tested
- Pelvic ultrasound / Urodynamic ultrasound
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic ultrasound / Urodynamic ultrasoundOther
Gynecological consultation: calculating the score ICI-Q Ultrasound consultation: pelvic ultrasound Urodynamic ultrasound during a Valsalva manoeuvers
| Study group | Role | What they receive |
|---|---|---|
| Continent women | Other | Women with ICI-Q=0 Pelvic ultrasound / Urodynamic ultrasound Receives: Other: Pelvic ultrasound / Urodynamic ultrasound |
| Incontinent women | Experimental | Women with ICI-Q≥1 Pelvic ultrasound / Urodynamic ultrasound Receives: Other: Pelvic ultrasound / Urodynamic ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of ultrasonic urethral length
LT total length LF functional length LE funnel urethral length Measurement of the angle between proximal and distal urethra
Measured: From 3 to 11 days after gynecological consultation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2018
- Study start10 Jul 2018
- Primary completion13 Jul 2020
- Study completion13 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Incontinence, UrinaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- CMC Ambroise Paré
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Georges BADER, MD, Principal investigator, CMC Hartmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03566121
- Sponsor's protocol ID
- 2018/01
- Acronym
- PRESIUS
- Status last verified
- Apr 2026
- First submitted
- 12 Jun 2018
- Last updated
- 8 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of the Severity of Female SUI by Measuring New Static and Dynamic Ultrasound Parameters of the Urethra
- ClinicalTrials.gov ID
- NCT03566121
- Acronym / sponsor ID
- PRESIUS / 2018/01
- Conditions
- Incontinence, Urinary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- CMC Ambroise ParéUniversity, hospital or other
- Study start
- 10 Jul 2018 (actual)
- Primary completion
- 13 Jul 2020 (actual)
- Study completion
- 13 Jul 2020 (actual)
- First posted
- 21 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continent women | Other | Other: Pelvic ultrasound / Urodynamic ultrasoundWomen with ICI-Q=0 Pelvic ultrasound / Urodynamic ultrasound |
| Incontinent women | Experimental | Other: Pelvic ultrasound / Urodynamic ultrasoundWomen with ICI-Q≥1 Pelvic ultrasound / Urodynamic ultrasound |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients aged over 18 years addressed to pelvic ultrasound
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvic ultrasound / Urodynamic ultrasoundGynecological consultation: calculating the score ICI-Q Ultrasound consultation: pelvic ultrasound Urodynamic ultrasound during a Valsalva manoeuvers | Other | Continent women, Incontinent women |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Results publication: PubMed 39716519Mal 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Georges BADER, MD principal investigator
CMC Hartmann
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic ultrasound / Urodynamic ultrasound in people with Incontinence, Urinary, run by CMC Ambroise Paré at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of ultrasonic urethral length (time frame: From 3 to 11 days after gynecological consultation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03566121, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.