Static and Functional Transperineal Ultrasonography for Identification of Stress Urinary Incontinence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 主要终点
- Mean urethral diameter
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Stress Urinary Incontinence
排除标准
- •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
结局指标
主要结局
Mean urethral diameter
时间窗: 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
Beta angle
时间窗: 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
Bladder-symphysis distance (BSD)
时间窗: 36 months
Distance in mm between the urine bladder neck and the symphysis
Gamma angle
时间窗: 36 months
Measurement of the angle in degrees between the lower margin of the symphysis pubis and the urinary bladder neck
Alpha angle
时间窗: 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)
Retrovesical angle (RVA)
时间窗: 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
次要结局
未报告次要终点
研究者
Iwona Magdalena Gawron
M.D., PhD., Principal Investigator
Jagiellonian University