跳至主要内容
临床试验/NCT07517978
NCT07517978招募中不适用

Evaluation of Vaginal Laxity and Bladder Neck Descent in Parous Women Using 2D and 3D Transperineal Ultrasound

Assiut University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2026年6月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
150
试验地点
1
主要终点
Levator Haital area after VD or CS

研究概览

简要总结

Evaluation of pelvic floor using 2D and 3D Transperineal Ultrasound

详细描述

Pelvic floor dysfunction (PFD) is a prevalent condition affecting women worldwide and includes pelvic organ prolapse, stress urinary incontinence (SUI), fecal incontinence, sexual dysfunction, and vaginal laxity. Vaginal laxity is increasingly recognized as a distressing symptom negatively affecting quality of life and sexual satisfaction. It has been strongly associated with levator ani muscle overstretching and enlargement of the levator hiatus, particularly following vaginal delivery.

Pregnancy and childbirth are major contributors to pelvic floor trauma [2]. Vaginal delivery may result in levator ani muscle injury, bladder neck descent, urethral hypermobility, and widening of the levator hiatus. These anatomical alterations predispose women to stress urinary incontinence and pelvic floor weakness.

Transperineal ultrasound has emerged as a reliable, non-invasive, and reproducible modality for assessing pelvic floor structures. Two- and three-dimensional ultrasound techniques allow accurate measurement of bladder neck mobility, retrovesical angle, levator hiatus dimensions, and levator ani integrity during rest and Valsalva maneuver.

However, limited studies have addressed the combined evaluation of vaginal laxity and bladder neck descent using both 2D and 3D transperineal ultrasound in parous women. Therefore, this study aims to evaluate these parameters and correlate them with mode of delivery and pelvic floor dysfunction symptoms

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • parous women

排除标准

  • pregnant women
  • previous prolapse surgery

研究组 & 干预措施

Group 2

Cesarean section

干预措施: Transperineal Ultrasound (Diagnostic Test)

Group 1

Vaginal delivery

干预措施: Transperineal Ultrasound (Diagnostic Test)

结局指标

主要结局

Levator Haital area after VD or CS

时间窗: 1 hour

Increased area means increase vaginal laxity

Levator Haital area after VD or CS

时间窗: 1 day

Increased area means increase vaginal laxity

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Gamal M.fekry

Lecturer obstetric and gynecology, Specialist Urogynecology

Assiut University

研究点 (1)

Loading locations...

相似试验