Transperineal Ultrasonography in Stress Urinary Incontinence

• Sponsor: Jagiellonian University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05912491
• Collaborator: (none)
• Enrollment: 71
• Actual Duration (Months): 130.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Stress Urinary Incontinence	Diagnostic Test: Transperineal ultrasonography

Detailed 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.

Study Design

• Study Type: Observational
• Actual Enrollment: 71 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Static and Functional Transperineal Ultrasonography for Identification of Stress Urinary Incontinence
• Actual Study Start Date: Jul 1, 2012
• Actual Primary Completion Date: Jul 1, 2015
• Actual Study Completion Date: May 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Urinary stress incontinence (UI) Women with clinical symptoms of stress urinary incontinence	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.
No Urinary stress incontinence (no-UI) Women without clinical symptoms of stress urinary incontinence	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.

Outcome Measures

Primary Outcome Measures

1. Bladder-symphysis distance (BSD) [36 months]

   Distance in mm between the urine bladder neck and the symphysis

2. Alpha angle [36 months]

   Measurement of the angle in degrees between the axis of the proximal urethra and the x-axis of the symphysis pubis (central line)

3. Beta angle [36 months]

   Measurement of the angle in degrees between the line parallel to the proximal urethra and the line parallel to the distal axis of urethra

4. Gamma angle [36 months]

   Measurement of the angle in degrees between the lower margin of the symphysis pubis and the urinary bladder neck

5. Retrovesical angle (RVA) [36 months]

   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

6. Mean urethral diameter [36 months]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Jagiellonian University

Investigators

• Study Chair: Kazimierz Pitynski, Ph.D., Prof., Jagiellonian University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Iwona Magdalena Gawron, M.D., PhD., Principal Investigator, Jagiellonian University
• ClinicalTrials.gov Identifier: NCT05912491
• Other Study ID Numbers: KBET/228/B/2010
• First Posted: Jun 22, 2023
• Last Update Posted: Jun 22, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Iwona Magdalena Gawron, M.D., PhD., Principal Investigator, Jagiellonian University: stress urinary incontinence, transperineal ultrasound
• Additional relevant MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress

Study Results

No Results Posted as of Jun 22, 2023