Valsalva Urethral Profile (VUP) : a New Measure to Assess Stress Urinary Incontinence in Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 695
- 主要终点
- Correlation between v-MUCP and VLPP
研究概览
简要总结
Clinical and paraclinical appraisal of stress urinary incontinence (SUI) is mainly based on the assessment of pelvic floor muscles (PFM) contraction and urethral mobility, the measurement of the maximum urethral closure pressure (MUCP) at rest by urethral pressure profilometry (UPP) and the measurement of the Valsalva leak point pressure (VLPP).
Currently, MUCP and VLPP cannot be used for diagnosing SUI because they appear to be moderately correlated with the severity of SUI.
The lack of a specific SUI biomarker could be the explanation for the poor predictive value of urodynamics and the ongoing debate on whether urodynamic testing before surgery has benefits. Our main objective was to study the value of a new urodynamic parameter in the diagnosis of female SUI: the Valsalva urethral profile (VUP)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women over the age of 18 years, referred for urodynamic exploration of the lower urinary tract, with or without lower urinary tract disorders (TUBA)
- •women who gave their consent to participate in the study.
排除标准
- •pelvic organ prolapse (POP) ≥ stage 2 according to the POP-Q classification
- •history of surgery for SUI and / or POP,
- •acute urinary tract infection,
- •proven neurological pathology,
- •urine retention,
- •a history of pneumothorax
- •a lability of MUCP ≥ 15 cmH2O
研究组 & 干预措施
v-MUCP value
All patients referred for urodynamics explorations will have a measure of the MUCP during a Valsalva manoeuver
干预措施: Maximum urethral closure pressure during Valsalva (v-MUCP) (Diagnostic Test)
结局指标
主要结局
Correlation between v-MUCP and VLPP
时间窗: through study completion, an average of 6 months
Spearman correlation, v-MUCP (valsalva Maximal Urethral Closure Pressure, cmH2O) and VLPP (Valsalva Leak Point Pressure, cmH2O) are urodyamic measures
Correlation between v-MUCP and diagnosis of SUI
时间窗: through study completion, an average of 6 months
Spearman correlation between the v-MCUP value and the ICIQ score. The ICIQ score (International Consultation on Incontinence Questionnaire-Urinary Incontinence) is a validated score used to quantify urinary incontinence (ranging from 0 = no incontinence to 21 = severe incontinence). v-MUCP (Valsalva Maximal Urethral Closure Pressure) is a urodynamic measure (measured in cmH2O). The Spearman correlation coefficient assesses how well the relationship between two variables can be described using a monotonic function.
Correlation between v-MUCP and MUCP
时间窗: through study completion, an average of 6 months
Spearman correlation coefficient. The Spearman correlation coefficient assesses how well the relationship between two variables can be described using a monotonic function. v-MUCP (Valsalva Maximal Urethral Closure Pressure) and MUCP Maximal Urethral Closure Pressure are two urodynamics measures (cmH2O)
Discrimination capacity of v-MUCP (valsalva Maximal Urethral Closure Pressure, cmH2O) for the diagnosis of SUI (ICIQ = 0 versus ICIQ > 0)
时间窗: through study completion, an average of 6 months
ROC curve. A Receiver Operating Characteristic (ROC) Curve is a way to compare diagnostic tests. It is a plot of the true positive rate against the false positive rate
次要结局
未报告次要终点
研究者
Anne Cecile Pizzoferrato
MD
Poissy-Saint Germain Hospital