Stress Urinary IncontinenceNCT06576791
Urethral Rotation Angles and Foot Pronation Mechanical Changes in Postmenopausal Women
An observational study of Stress Urinary Incontinence, run by Cairo University at 1 site in Egypt.
Trial summary
Stress urinary incontinence (SUI) occur secondary to increased intra abdominal pressure, that directed the researchers to study the mechanical changes in urethra and bladder that associated with it. However, these urethral mechanical changes may be related to other mechanical changes in the body. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress Urinary Incontinence
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Sep 2021to 1 Jan 2022
- Phase
- Observational
- 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 40 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: ll participants were assessed for their eligibility to participate in the study if they multiparous vaginal delivery women experienced more than one delivery with average three deliveries.
Who may be able to join
- multiparous vaginal delivery women
- experienced more than one delivery.
Who cannot join
- urinary tract infection
- any previous genitourinary surgery
- congenital bone deformities, pelvic organ prolapse
- taking any drugs for treating SUI
- any hormonal replacement therapy
- residual urine more than 150cc
- history of lung diseases associated with chronic coughs
Trial locations and contacts
1 site in 1 country.
About this study
Stress urinary incontinence (SUI) occur secondary to increased intra abdominal pressure, that directed the researchers to study the mechanical changes in urethra and bladder that associated with it. However, these urethral mechanical changes may be related to other mechanical changes in the body.
Read the detailed description
Stress urinary incontinence (SUI) affects about 26% of women between 30 and 59 years of age. It is the sudden involuntary urine leakage secondary to increased intra abdominal pressure related to physical activities as laughing, sneezing, straining, coughing, or exercising . There are two common mechanisms for SUI: urethral hypermobility due to loss of support of the bladder neck and urethra (affected by increased intra-abdominal pressure), and weakness of the urinary sphincter that may result from trauma, repeated urogynaecological surgeries, neurological disease, ageing or diseases leading to systemic muscular atrophy. SUI is the most common pelvic floor dysfunction linked to the vaginal delivery. However the prevalence of stress incontinence peaks occurs in the fifth decade of life . and all types of incontinence are commonly occurring with ageing and obesity.
Urethral hypermobility means that the proximal part of the urethra may exhibit a rotational movement in a postero-inferior direction. And it was diagnosed when the urethra rotated during strain over 30° from its resting axis . Urethral rotation angles may assist in both assessment and diagnosis of patients with SUI, which may in turn decreases requires for any other investigations .The ultrasonography assessment of the angle of inclination (α angle: the angle between the axis of the proximal urethra and the central axis of the symphysis pubis) and posterior urethrovesical angle (β angle: the angle between the proximal urethra and the posterior vesical wall) has been investigated by several researchers. However, recently transperineal ultrasonography is a practical, reliable, non-invasive and comfortable method for evaluation of SUI. Additionally, it has the advantage of dynamic evaluation during the Valsalva maneuver .
Urinary sphincter composed of; internal urethral sphincter that is predominantly smooth muscle without voluntary control, and the external urethral sphincter and pelvic floor muscles (PFMs) that are predominantly striated muscle with voluntary control. During activities the PFMs contract to prevent the leakage of urine, in addition, they play a significant role in trunk stabilization through its connections with abdominal muscles, diaphragm, and gluteus by myofascial continuity . Contractions of PFMs lead to activation of gluteal muscles especially the levator ani through their connection by the fossa ischioanalis . Additionally, rotators mainly the internal obturator and piriformis muscles are important for maintaining pelvic stability and PFM functionality .Moreover, the tension of the rotator cuff and gluteal muscles is also primarily determined by position of the foot. So, the tension of PFM may affect the tension and functioning of the rotators and gluteal muscles, thus influencing the biomechanics and position of whole lower limb even the foot position .
- Conditions
- Stress Urinary Incontinence
- Medical subject headings
- Urinary Incontinence, Stress
What is being measured
The primary outcome is the main question the study is designed to answer.
1- Measuring urethral rotation angles by transperineally ultrasound TPUS
TPUS was performed using a Toshiba US machine with a 3.5 MHz electronic micro convex array probe. The bladder was comfortably partially filled with urine (about 150 mL).
Measured: 3 months
2- foot pronation
drop test
Measured: 3 months
Secondary outcomes (1)
weight
kg
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start4 Sep 2021
- Primary completion1 Dec 2021
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Cairo 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 only
- Time perspective
- Other
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, rovan mohamed saad elbesh, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06576791
- Sponsor's protocol ID
- [P.T.REC/012/004226]
- Status last verified
- Jun 2024
- First submitted
- 19 Sep 2022
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urethral Rotation Angles and Foot Pronation Mechanical Changes in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT06576791
- Acronym / sponsor ID
- [P.T.REC/012/004226]
- Conditions
- Stress Urinary Incontinence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 4 Sep 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 29 Aug 2024 (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) occur secondary to increased intra abdominal pressure, that directed the researchers to study the mechanical changes in urethra and bladder that associated with it. However, these urethral mechanical changes may be related to other mechanical changes in the body.
Detailed description
Stress urinary incontinence (SUI) affects about 26% of women between 30 and 59 years of age. It is the sudden involuntary urine leakage secondary to increased intra abdominal pressure related to physical activities as laughing, sneezing, straining, coughing, or exercising . There are two common mechanisms for SUI: urethral hypermobility due to loss of support of the bladder neck and urethra (affected by increased intra-abdominal pressure), and weakness of the urinary sphincter that may result from trauma, repeated urogynaecological surgeries, neurological disease, ageing or diseases leading to systemic muscular atrophy. SUI is the most common pelvic floor dysfunction linked to the vaginal delivery. However the prevalence of stress incontinence peaks occurs in the fifth decade of life . and all types of incontinence are commonly occurring with ageing and obesity.
Urethral hypermobility means that the proximal part of the urethra may exhibit a rotational movement in a postero-inferior direction. And it was diagnosed when the urethra rotated during strain over 30° from its resting axis . Urethral rotation angles may assist in both assessment and diagnosis of patients with SUI, which may in turn decreases requires for any other investigations .The ultrasonography assessment of the angle of inclination (α angle: the angle between the axis of the proximal urethra and the central axis of the symphysis pubis) and posterior urethrovesical angle (β angle: the angle between the proximal urethra and the posterior vesical wall) has been investigated by several researchers. However, recently transperineal ultrasonography is a practical, reliable, non-invasive and comfortable method for evaluation of SUI. Additionally, it has the advantage of dynamic evaluation during the Valsalva maneuver .
Urinary sphincter composed of; internal urethral sphincter that is predominantly smooth muscle without voluntary control, and the external urethral sphincter and pelvic floor muscles (PFMs) that are predominantly striated muscle with voluntary control. During activities the PFMs contract to prevent the leakage of urine, in addition, they play a significant role in trunk stabilization through its connections with abdominal muscles, diaphragm, and gluteus by myofascial continuity . Contractions of PFMs lead to activation of gluteal muscles especially the levator ani through their connection by the fossa ischioanalis . Additionally, rotators mainly the internal obturator and piriformis muscles are important for maintaining pelvic stability and PFM functionality .Moreover, the tension of the rotator cuff and gluteal muscles is also primarily determined by position of the foot. So, the tension of PFM may affect the tension and functioning of the rotators and gluteal muscles, thus influencing the biomechanics and position of whole lower limb even the foot position .
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- ll participants were assessed for their eligibility to participate in the study if they multiparous vaginal delivery women experienced more than one delivery with average three deliveries.
Key inclusion criteria (2 listed)
- multiparous vaginal delivery women
- experienced more than one delivery.
Key exclusion criteria (7 listed)
- urinary tract infection
- any previous genitourinary surgery
- congenital bone deformities, pelvic organ prolapse
- taking any drugs for treating SUI
- any hormonal replacement therapy
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
1- Measuring urethral rotation angles by transperineally ultrasound TPUS
Time frame: 3 months
TPUS was performed using a Toshiba US machine with a 3.5 MHz electronic micro convex array probe. The bladder was comfortably partially filled with urine (about 150 mL).
2- foot pronation
Time frame: 3 months
drop test
1 secondary outcome
weight
Time frame: 3 months
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 19 Dec 2024.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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, run by Cairo 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?
The sponsor lists 2 inclusion and 7 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 19 Dec 2024. 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?
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?
1- Measuring urethral rotation angles by transperineally ultrasound TPUS (time frame: 3 months). The study lists 2 primary outcomes in all. 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 19 Dec 2024.