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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Egypt1 site
  • Rovan Elbesh

    Giza, 12651

Other trials in Egypt

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 .

Medical subject headings
Urinary Incontinence, Stress

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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. 2- foot pronation

    drop test

    Measured: 3 months

Secondary outcomes (1)
  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.

  1. First posted29 Aug 2024
  2. Study start4 Sep 2021
  3. Primary completion1 Dec 2021
  4. Study completion1 Jan 2022

Resources

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)
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

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.

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