Transperineal Ultrasonography in Stress Urinary Incontinence

NCT05912491 | Completed DMC

• 1 other identifier: KBET/228/B/2010
• Study Type: observational
• Target: 71
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stress Urinary Incontinence

Keywords

stress urinary incontinence, transperineal ultrasound

Outcome Measures

Primary Outcomes (6)

• Bladder-symphysis distance (BSD)

  Distance in mm between the urine bladder neck and the symphysis

  36 months

• 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

• 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

• Gamma angle

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

  36 months

• 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

• 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

Study Arms (2)

Urinary stress incontinence (UI)

Women with clinical symptoms of stress urinary incontinence

Diagnostic Test: Transperineal ultrasonography

No Urinary stress incontinence (no-UI)

Women without clinical symptoms of stress urinary incontinence

Diagnostic Test: Transperineal ultrasonography

Interventions

Transperineal ultrasonography DIAGNOSTIC_TEST

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); Urinary stress incontinence (UI)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women hospitalised at the Clinical Department of Gynecological Oncology and Gynecology, University Hospital in Krakow, between July 2012 and July 2015, aged over 18 years. The presence of stress urinary incontinence (SUI) requiring surgical management was the inclusion criterion. The control group included patients without UI referred for surgery due to mild gynaecological disorders. Exclusion criteria included prior surgery for either UI or POP, pelvic tumours that could affect pelvic organ statics, and lack of informed consent to participate in the study.

You may qualify if:

• Stress Urinary Incontinence

You may not qualify if:

• 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

Sponsors & Collaborators

• Jagiellonian University: lead

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kazimierz Pitynski, Ph.D., Prof.

  Jagiellonian University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., PhD., Principal Investigator

Study Record Dates

• First Submitted: June 13, 2023
• First Posted: June 22, 2023
• Study Start: July 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: May 30, 2023
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share