Stress Urinary Incontinence (SUI)UDS - PFUNCT06886997
PFU vs. UDS in SUI
An observational study of Stress Urinary Incontinence (SUI), run by Ain Shams University.
Trial summary
The goal of this observational stury is to test the diagnostic accuracy of Pelvic Floor Ultrasound in evaluating women with stress urinary incontinence compared to the reference standard Urodynamic Studies. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress Urinary Incontinence (SUI)
- What is being tested?
- Pelvic Floor Ultrasound and Urodynamic studies
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to 1 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: adult women complaining of stress urinary incontinence
Who may be able to join
- Aged ≥ 18 years
Who cannot join
- Medical history of neurological disorders, cognitive disorders, dementia, Alzheimer's disease, or uncontrolled DM.
- Surgical history of continence or prolapse procedure.
- Examination showing anterior or middle compartment decent with POP-Q staging greater than stage 1, or urogenital fistula.
- Known lower urinary tract or genital tract anomalies or tumors.
About this study
Official title: Pelvic Floor Ultrasound Versus Urodynamic Studies in Evaluating Women With Stress Urinary Incontinence
The goal of this observational stury is to test the diagnostic accuracy of Pelvic Floor Ultrasound in evaluating women with stress urinary incontinence compared to the reference standard Urodynamic Studies. The main question it aims to answer is:
Is Pelvic floor ultrasound as accurate as urodynamic studies in diagnosis of stress urinary incontinence?
- Conditions
- Stress Urinary Incontinence (SUI)
- Being tested
- Pelvic Floor Ultrasound, Urodynamic studies
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic Floor UltrasoundDiagnostic test
Pelvic Floor Ultrasound will be carried out by a sonographer expert in the technique and who will be blinded from the data of clinical examination as well as the UDS results. The 3D/4D abdominal ultrasound probe will be used to perform a transperineal scan to capture midsagittal pelvic floor views. The test will be conducted both at resting state and during the maximum Valsalva maneuver.
Urodynamic studiesDiagnostic test
Urodynamic studies (UDS) will be carried out according to the usual protocol and will include: cystometry, Valsalva leak point pressure, urethral pressure profile, and uroflowmetry.
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of pelvic floor ultrasound in assessment of stress urinary incontinence compared to urodynamic testing.
Key Measurements in PFU:
Bladder neck position at resting and Valsalva states. Bladder Neck Mobility Posterior vesicourethral angle Urethral inclination angle Distance from the external urethral orifice to the bladder neck at resting state.
Bladder Neck Funneling (BNF)
Key Parameters Measured in Urodynamics:
Presence or absence of SUI Presence or absence of Detrusor Overactivity leak point pressure
Diagnostic accuracy will be assessed according to (sensitivity, specificity, positive and negative predictive values) of PFU compared to UDS (as the gold standard)
Measured: Within a week of UDS appointment
Secondary outcomes (2)
Patient satisfaction
Patient satisfaction by asking which test would she prefer to repeat if needed: the urodynamic study, pelvic floor sonography, or neither?
Measured: Within a week of UDS appointment
Cost
Cost in Egyptian Pounds EGP
Measured: Within a week of UDS appointment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start1 Jun 2025 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Stress Urinary Incontinence (SUI)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salma Salah Eltounsi, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06886997
- Sponsor's protocol ID
- UDS-PFU
- Acronym
- UDS - PFU
- Status last verified
- Mar 2025
- First submitted
- 10 Mar 2025
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
Publications
Yao M, Simoes A. Urodynamic Testing and Interpretation. 2023 Aug 14. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK562310/
PubMed 32965981Pietrus M, Pitynski K, Socha MW, Gawron I, Biskupski-Brawura-Samaha R, Waligora M. Enhanced Non-Invasive Diagnosis of Female Urinary Incontinence Using Static and Functional Transperineal Ultrasonography. Diagnostics (Basel). 2024 Nov 14;14(22):2549. doi: 10.3390/diagnostics14222549.
PubMed 39594215Malmur M, Mlodawski J, Mlodawska M, Misiek M, Adamczyk-Gruszka O, Niziurski P, Gluszek S, Rokita W. Could pelvic floor sonography be a standalone method for excluding genuine stress urinary incontinence in women? Ginekol Pol. 2023 Mar 17. doi: 10.5603/GP.a2023.0026. Online ahead of print.
PubMed 36929790Lugo T, Leslie SW, Mikes BA, Riggs J. Stress Urinary Incontinence. 2024 Aug 31. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK539769/
PubMed 30969591Hu Y, Lou YL, Zhu SX, Zhang H, Huang T, Wu H, Xie LP. Pelvic floor ultrasound versus urodynamics in evaluating insensible urinary incontinence: A retrospective study. Prog Urol. 2023 Jul;33(7):384-392. doi: 10.1016/j.purol.2023.05.002. Epub 2023 Jun 2.
PubMed 37271669Dietz HP. Pelvic Floor Ultrasound: A Review. Clin Obstet Gynecol. 2017 Mar;60(1):58-81. doi: 10.1097/GRF.0000000000000264.
PubMed 28005595Dietz HP. Pelvic floor ultrasound in incontinence: what's in it for the surgeon? Int Urogynecol J. 2011 Sep;22(9):1085-97. doi: 10.1007/s00192-011-1402-7. Epub 2011 Apr 22.
PubMed 21512829Bahrami S, Khatri G, Sheridan AD, Palmer SL, Lockhart ME, Arif-Tiwari H, Glanc P. Pelvic floor ultrasound: when, why, and how? Abdom Radiol (NY). 2021 Apr;46(4):1395-1413. doi: 10.1007/s00261-019-02216-8.
PubMed 31529202
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pelvic Floor Ultrasound Versus Urodynamic Studies in Evaluating Women With Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT06886997
- Acronym / sponsor ID
- UDS - PFU / UDS-PFU
- Conditions
- Stress Urinary Incontinence (SUI)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 20 Mar 2025 (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.
The goal of this observational stury is to test the diagnostic accuracy of Pelvic Floor Ultrasound in evaluating women with stress urinary incontinence compared to the reference standard Urodynamic Studies. The main question it aims to answer is:
Is Pelvic floor ultrasound as accurate as urodynamic studies in diagnosis of stress urinary incontinence?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- adult women complaining of stress urinary incontinence
Key inclusion criteria (1 listed)
- Aged ≥ 18 years
Key exclusion criteria (4 listed)
- Medical history of neurological disorders, cognitive disorders, dementia, Alzheimer's disease, or uncontrolled DM.
- Surgical history of continence or prolapse procedure.
- Examination showing anterior or middle compartment decent with POP-Q staging greater than stage 1, or urogenital fistula.
- Known lower urinary tract or genital tract anomalies or tumors.
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 Floor UltrasoundPelvic Floor Ultrasound will be carried out by a sonographer expert in the technique and who will be blinded from the data of clinical examination as well as the UDS results. The 3D/4D abdominal ultrasound probe will be used to perform a transperineal scan to capture midsagittal pelvic floor views. The test will be conducted both at resting state and during the maximum Valsalva maneuver. | Diagnostic test | – |
| Urodynamic studiesUrodynamic studies (UDS) will be carried out according to the usual protocol and will include: cystometry, Valsalva leak point pressure, urethral pressure profile, and uroflowmetry. | Diagnostic test | – |
Primary outcome
Accuracy of pelvic floor ultrasound in assessment of stress urinary incontinence compared to urodynamic testing.
Time frame: Within a week of UDS appointment
Key Measurements in PFU: Bladder neck position at resting and Valsalva states. Bladder Neck Mobility Posterior vesicourethral angle Urethral inclination angle Distance from the external urethral orifice to the bladder neck at resting state. Bladder Neck Funneling (BNF) Key Parameters Measured in Urodynamics: Presence or absence of SUI Presence or absence of Detrusor Overactivity leak point pressure Diagnostic accuracy will be assessed according to (sensitivity, specificity, positive and negative predictive values) of PFU compared to UDS (as the gold standard)
2 secondary outcomes
Patient satisfaction
Time frame: Within a week of UDS appointment
Cost
Time frame: Within a week of UDS appointment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
- Background: PubMed 32965981Yao M, Simoes A. Urodynamic Testing and Interpretation. 2023 Aug 14. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK562310/
- Background: PubMed 39594215Pietrus M, Pitynski K, Socha MW, Gawron I, Biskupski-Brawura-Samaha R, Waligora M. Enhanced Non-Invasive Diagnosis of Female Urinary Incontinence Using Static and Functional Transperineal Ultrasonography. Diagnostics (Basel). 2024 Nov 14;14(22):2549. doi: 10.3390/diagnostics14222549.
- Background: PubMed 36929790Malmur M, Mlodawski J, Mlodawska M, Misiek M, Adamczyk-Gruszka O, Niziurski P, Gluszek S, Rokita W. Could pelvic floor sonography be a standalone method for excluding genuine stress urinary incontinence in women? Ginekol Pol. 2023 Mar 17. doi: 10.5603/GP.a2023.0026. Online ahead of print.
- Background: PubMed 30969591Lugo T, Leslie SW, Mikes BA, Riggs J. Stress Urinary Incontinence. 2024 Aug 31. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK539769/
- Background: PubMed 37271669Hu Y, Lou YL, Zhu SX, Zhang H, Huang T, Wu H, Xie LP. Pelvic floor ultrasound versus urodynamics in evaluating insensible urinary incontinence: A retrospective study. Prog Urol. 2023 Jul;33(7):384-392. doi: 10.1016/j.purol.2023.05.002. Epub 2023 Jun 2.
- Background: PubMed 28005595Dietz HP. Pelvic Floor Ultrasound: A Review. Clin Obstet Gynecol. 2017 Mar;60(1):58-81. doi: 10.1097/GRF.0000000000000264.
- Background: PubMed 21512829Dietz HP. Pelvic floor ultrasound in incontinence: what's in it for the surgeon? Int Urogynecol J. 2011 Sep;22(9):1085-97. doi: 10.1007/s00192-011-1402-7. Epub 2011 Apr 22.
- Background: PubMed 31529202Bahrami S, Khatri G, Sheridan AD, Palmer SL, Lockhart ME, Arif-Tiwari H, Glanc P. Pelvic floor ultrasound: when, why, and how? Abdom Radiol (NY). 2021 Apr;46(4):1395-1413. doi: 10.1007/s00261-019-02216-8.
Related trials for Stress Urinary Incontinence (SUI)
Not yet recruiting
Anterior Bridge-Preserving Versus Conventional Early Apical Release in Bipolar Enucleation of the Prostate
Benign Prostatic Hyperplasia, Benign Prostatic Obstruction
Active, not recruiting
A Study to Assess the Safety and Effectiveness of the UrOActive® Artificial Urinary sPHincter (AUS)
Stress Urinary Incontinence (SUI)
Recruiting
Comparing the Effect of Two Types of Pelvic Floor Muscle Stimulation Devices to Improve Symptoms of Urinary Incontinence in Women.
Urinary Incontinence, Mixed Urinary Incontinence
Recruiting
The Effects of Expiratory Muscle Strength Training in Women With Stress Urinary Incontinence
Stress Urinary Incontinence (SUI)
Recruiting
Effect of High-Intensity Focused Electromagnetic (HIFEM) Technology in the Treatment of SUI in Chinese Men Undergone Robotic Radical Prostatectomy
Urinary Incontinence , Stress, Prostatectomy
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress Urinary Incontinence (SUI), run by Ain Shams University.
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 4 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: opening soon, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Accuracy of pelvic floor ultrasound in assessment of stress urinary incontinence compared to urodynamic testing. (time frame: Within a week of UDS appointment). 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 NCT06886997, which also lists 8 linked publications.
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 20 May 2025.