Transperineal Ultrasonography in Stress Urinary Incontinence

Stress Urinary Incontinence Clinical Trial

Official title:

Static and Functional Transperineal Ultrasonography for Identification of Stress Urinary Incontinence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05912491
• Other study ID #: KBET/228/B/2010
• Status: Completed
• Start date: July 1, 2012
• Est. completion date: May 30, 2023

Study information

• Verified date: June 2023
• Source: Jagiellonian University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Pelvic organ prolapse (POP) and urinary incontinence (UI) are common female disorders. Accurate diagnosis of the aetiology of pelvic organ descent and prolapse with or without accompanying urination disorders is essential for appropriate therapeutic management. Imaging and functional urodynamic testing are being increasingly used in the diagnosis of this pathology, because precise assessment of the damage to the supporting and ligament apparatus is essential for therapeutic success. Pelvic floor ultrasound can facilitate dynamic assessment of static changes that occur during functional tests. Such assessments can provide additional insights into existing defects, which have explorative value and allow for targeted correction of damage, and may thus indirectly contribute to reduced rates of revision surgeries.

Description:

Application of the ultrasound transducer to the patient's perineum can visualise three female pelvic compartments, and the images can be frozen to assess the positions of anatomical structures in relation to the pelvic bones and the pre-set planes as well as measure their mutual distances and predefined angles.

The aim of the study was to assess the utility of ultrasound in the detection of UI, particularly for establishing the most useful anatomical and functional parameters and to propose cut-off points for ultrasonographic parameters. The presence of stress urinary incontinence (SUI) requiring surgical management was the inclusion criterion. All patients underwent transperineal ultrasound (TPU) with a Voluson E6 (GE Medical systems, Milwaukee, WI, USA). The probe was oriented to coaxially visualise the pubic symphysis on one side and the anus and rectum on the other side of the 2D image. When all three compartments could not be visualised in one image, one image showing the anterior and medial compartments and another image showing the medial and posterior compartments were obtained instead. Next, 3D/4D ultrasound was performed to obtain an image in the coronal plane at the level of the arms of the levator ani muscle, showing the pubic symphysis and the anus. All measurements were performed in three states: during pelvic muscle relaxation, during Valsalva manoeuvre, and during perineal squeezing. The following quantitative parameters were assessed and compared across two arms of the study (with and without SUI):

• Bladder-symphysis distance (BSD) - measured as the distance between the urine bladder neck and the symphysis,

• Alpha angle - the angle between the axis of the proximal urethra and the x-axis of the symphysis pubis (central line),

• Beta angle - the angle between the line parallel to the proximal urethra and the line parallel to the distal axis of urethra,

• Gamma angle - the angle between the lower margin of the symphysis pubis and the urinary bladder neck),

• Retrovesical angle (RVA) - the angle between the axis of the proximal urethra and the tangent line to the lowest part of the posterior wall of the urinary bladder,

• Mean urethral diameter - the sum of the urethral diameters at three points (proximal, central, and distal parts) divided by 3.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: May 30, 2023
• Est. primary completion date: July 1, 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Stress Urinary Incontinence

Exclusion Criteria:

• Failure to obtain endpoint measurements due to lack of cooperation during the ultrasound examination

• Prior surgery for either UI or POP

• Pelvic tumours

• Lack of consent to participate in the study

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Diagnostic Test:
• Transperineal ultrasonography
Transperineal ultrasound (TPU) with a Voluson E6 (GE Medical systems, Milwaukee, WI, USA). The probe was oriented to coaxially visualise the pubic symphysis on one side and the anus and rectum on the other side of the 2D image. Next, 3D/4D ultrasound was performed to obtain an image in the coronal plane at the level of the arms of the levator ani muscle, showing the pubic symphysis and the anus. All measurements were performed in three states: during pelvic muscle relaxation, during Valsalva manoeuvre, and during perineal squeezing.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jagiellonian University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bladder-symphysis distance (BSD)	Distance in mm between the urine bladder neck and the symphysis	36 months
Primary	Alpha angle	Measurement of the angle in degrees between the axis of the proximal urethra and the x-axis of the symphysis pubis (central line)	36 months
Primary	Beta angle	Measurement of the angle in degrees between the line parallel to the proximal urethra and the line parallel to the distal axis of urethra	36 months
Primary	Gamma angle	Measurement of the angle in degrees between the lower margin of the symphysis pubis and the urinary bladder neck	36 months
Primary	Retrovesical angle (RVA)	Measurement of the angle in degrees between the axis of the proximal urethra and the tangent line to the lowest part of the posterior wall of the urinary bladder	36 months
Primary	Mean urethral diameter	Mean urethral diameter in mm obtained by summing the urethral diameters at three points (proximal, mid, and distal) and dividing the sum obtained by 3	36 months