Stress Urinary Incontinence in WomenNCT07747727
Perineal Ultrasound, Post-Void Residual, and Lower-Limb Alignment in Stress Incontinence
An observational study of Stress Urinary Incontinence in Women, run by Benha University at 1 site in Egypt.
Trial summary
Stress urinary incontinence (SUI) in postmenopausal women is traditionally considered a local pelvic floor disorder, but emerging evidence suggests that spinopelvic and lower limb alignment may also contribute to continence mechanisms. Read more about this study
- Who is it for?
- Ages 50 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress Urinary Incontinence in Women
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Feb 2026to 15 Aug 2026
- 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 50 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: included postmenopausal women aged 50 years or older who had at least 12 months of amenorrhea or follicle-stimulating hormone values within the menopausal range and who could stand and walk independently to allow lower-limb and alignment assessments
Inclusion Criteria: post menoupausal women, who had at least 12 months of amenorrhea or follicle-stimulating hormone values within the menopausal range and who could stand and walk independently to allow lower-limb and alignment assessments.
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Exclusion Criteria:women with urge or mixed incontinence as the dominant symptom, prior pelvic floor or anti-incontinence surgery, severe pelvic organ prolapse (stage 3 or greater), or neurological conditions affecting bladder function or gait, as well as those with hip or spine surgery likely to alter spinopelvic parameters
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Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
out patient clinic, Faculty of Physical Therapy, Benha University
Banhā, Qalyoubia, 13518
Aliaa Elabd, aliaelabd88@gmail.com
About this study
Official title: Perineal Ultrasound α/β Angles, Post-Void Residual Volume, and Lower-Limb Alignment in Symptomatic and Asymptomatic Postmenopausal Women With Stress Incontinence.
Stress urinary incontinence (SUI) in postmenopausal women is traditionally considered a local pelvic floor disorder, but emerging evidence suggests that spinopelvic and lower limb alignment may also contribute to continence mechanisms. Transperineal ultrasound α/β angles and post void residual (PVR) volume are promising imaging markers that might capture this broader biomechanical phenotype.
Objective To compare hip ultrasound α/β angles, PVR volume, and lower limb and spinopelvic alignment between symptomatic and asymptomatic postmenopausal women, and to explore within group correlations between PVR and musculoskeletal alignment variables.
Read the detailed description
We conducted an observational case-control study with coordinated cross sectional analyses of two anonymised datasets from a tertiary urogynecology outpatient clinic in Saudi Arabia. Postmenopausal women (≥50 years) able to stand and walk independently were classified as symptomatic (SUI) if they reported stress related leakage and had an elevated International Consultation on Incontinence Questionnaire-Short Form score, or as asymptomatic controls if they denied leakage and had minimal symptom scores. Primary outcomes were transperineal hip ultrasound α/β angles at rest and during Valsalva, PVR volume, navicular drop test (NDT), spinopelvic parameters (pelvic incidence, pelvic tilt, sacral slope), tibial and femoral torsion, and Q angles. Between group comparisons used parallel parametric and non parametric tests with Holm-Bonferroni correction, and within group correlations between PVR and alignment variables were assessed with Pearson and Spearman coefficients.
- Conditions
- Stress Urinary Incontinence in Women
- Keywords
- Stress Urinary Incontinence, Postmenopause, Ultrasonography, Postvoid Residual Urine, Lower Extremity
- 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.
| Study group | Role | What they receive |
|---|---|---|
| symptomatic stress urinary incontinence | they reported stress-related urine leakage during effort, exertion, sneezing, or coughing and had an International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) or equivalent score above a predefined threshold ≥6). | |
| asymptomatic controls (Normal group) | they reported no involuntary urine leakage in the preceding 12 months and had an ICIQ-SF score between 0 and 2; both cases and controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
hip ultrasound parameters
we measured hip ultrasound angles describing urethrovesical and retrovesical configurations at rest and during a Valsalva or valgus manoeuvre, expressed in degrees.
Trained clinicians performed transperineal ultrasound examinations in the lithotomy or semi-recumbent position, capturing angle measurements at rest and during standardized Valsalva efforts; we then recorded the mean of repeated readings to reduce measurement error.
Measured: At a single study visit (baseline)
Secondary outcomes (3)
Lower-Limb and Foot Posture Measures
We assessed foot posture using the navicular drop test (NDT), recorded in millimetres as the vertical displacement of the navicular tuberosity between subtalar neutral and relaxed stance.
We measured Q-angles (quadriceps angle) using both computed tomography (CT) and goniometric methods for the right and left lower limbs
Measured: At a single study visit (baseline)
Spinopelvic Alignment and Torsion
Spinopelvic parameters included pelvic incidence, pelvic tilt, and sacral slope, all measured in degrees from radiographic
Measured: At a single study visit (baseline)
Post-Void Residual Volume
We measured post-void residual volume in millilitres using standardized bladder ultrasound immediately after participants attempted to empty their bladder.
Measured: At a single study visit (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start3 Feb 2026
- Primary completion2 Aug 2026 (estimated)
- Study completion15 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary Incontinence in WomenStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aliaa Mohamed Elabd, Benha University
- Investigators
- Aliaa M Elabd, assistant professor, Study director, Faculty of Physical Therapy, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07747727
- Sponsor's protocol ID
- PT. BU. EC. 45
- Status last verified
- Jul 2026
- First submitted
- 31 Jul 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perineal Ultrasound α/β Angles, Post-Void Residual Volume, and Lower-Limb Alignment in Symptomatic and Asymptomatic Postmenopausal Women With Stress Incontinence.
- ClinicalTrials.gov ID
- NCT07747727
- Acronym / sponsor ID
- PT. BU. EC. 45
- Conditions
- Stress Urinary Incontinence in Women
- Keywords
- Stress Urinary Incontinence, Postmenopause, Ultrasonography, Postvoid Residual Urine, Lower Extremity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 3 Feb 2026 (actual)
- Primary completion
- 2 Aug 2026 (estimated)
- Study completion
- 15 Aug 2026 (estimated)
- First posted
- 5 Aug 2026 (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.
Stress urinary incontinence (SUI) in postmenopausal women is traditionally considered a local pelvic floor disorder, but emerging evidence suggests that spinopelvic and lower limb alignment may also contribute to continence mechanisms. Transperineal ultrasound α/β angles and post void residual (PVR) volume are promising imaging markers that might capture this broader biomechanical phenotype.
Objective To compare hip ultrasound α/β angles, PVR volume, and lower limb and spinopelvic alignment between symptomatic and asymptomatic postmenopausal women, and to explore within group correlations between PVR and musculoskeletal alignment variables.
Detailed description
We conducted an observational case-control study with coordinated cross sectional analyses of two anonymised datasets from a tertiary urogynecology outpatient clinic in Saudi Arabia. Postmenopausal women (≥50 years) able to stand and walk independently were classified as symptomatic (SUI) if they reported stress related leakage and had an elevated International Consultation on Incontinence Questionnaire-Short Form score, or as asymptomatic controls if they denied leakage and had minimal symptom scores. Primary outcomes were transperineal hip ultrasound α/β angles at rest and during Valsalva, PVR volume, navicular drop test (NDT), spinopelvic parameters (pelvic incidence, pelvic tilt, sacral slope), tibial and femoral torsion, and Q angles. Between group comparisons used parallel parametric and non parametric tests with Holm-Bonferroni correction, and within group correlations between PVR and alignment variables were assessed with Pearson and Spearman coefficients.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| symptomatic stress urinary incontinence | – | –they reported stress-related urine leakage during effort, exertion, sneezing, or coughing and had an International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) or equivalent score above a predefined threshold ≥6). |
| asymptomatic controls (Normal group) | – | –they reported no involuntary urine leakage in the preceding 12 months and had an ICIQ-SF score between 0 and 2; both cases and controls |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- included postmenopausal women aged 50 years or older who had at least 12 months of amenorrhea or follicle-stimulating hormone values within the menopausal range and who could stand and walk independently to allow lower-limb and alignment assessments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
hip ultrasound parameters
Time frame: At a single study visit (baseline)
we measured hip ultrasound angles describing urethrovesical and retrovesical configurations at rest and during a Valsalva or valgus manoeuvre, expressed in degrees. Trained clinicians performed transperineal ultrasound examinations in the lithotomy or semi-recumbent position, capturing angle measurements at rest and during standardized Valsalva efforts; we then recorded the mean of repeated readings to reduce measurement error.
3 secondary outcomes
Lower-Limb and Foot Posture Measures
Time frame: At a single study visit (baseline)
Spinopelvic Alignment and Torsion
Time frame: At a single study visit (baseline)
Post-Void Residual Volume
Time frame: At a single study visit (baseline)
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 5 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
Aliaa M Elabd, assistant professor study director
Faculty of Physical Therapy, Benha University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress Urinary Incontinence in Women, run by Benha University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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?
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?
Contact Aliaa M Elabd, assistant professor (00201069352446, aliaelabd88@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hip ultrasound parameters (time frame: At a single study visit (baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Aug 2026.