Evaluation of 3D Translabial Ultrasound Imaging for Pessary Size Estimation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- 3D ultrasound images and pressure/volume measurements of vagina in patients with pelvic organ prolapse
研究概览
简要总结
This is a feasibility study looking at the use of 3D ultrasound with vaginal manometry at various distension volumes to predict the best available pessary for successful fit.
详细描述
Patients who are currently using a pessary for management of pelvic organ prolapse and who are able to remove/replace the pessary themselves will be approached for recruitment. The pessary will be removed two days prior to 3D translabial ultrasound. The vagina will be distended with a pressurized compliant bag with concurrent pressure and volume measurements. Translabial ultrasound will be used to measure structural parameters within the vagina at varying pressures/volumes. The volume, pressure and structural parameters measured will be compared to dimensions of the patient's own pessary to develop mathematical models to predict the best available pessary choice for the patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •are current pessary users (> 6 months) who have no pessary related complication, including discomfort, vaginal bleeding, and pessary extrusion
- •are able to provide informed consent
- •can perform self-care, i.e. removing and inserting the pessary themselves
- •are willing to remove their pessary two days before the ultrasound examination date
排除标准
- •inability to give informed consent
- •inability to communicate with the person performing the consent and the sonographer performing ultrasound scanning
- •history of pelvic radiation or surgery (excluding hysterectomy)
- •using pessaries other than ring, incontinence dish, donut, Shaatz
- •inability to perform the Valsalva maneuver or pelvic floor contraction
- •restricted mobility that prevents them from ambulating to assess the comfort level of the pessary during the initial pessary fitting visit
- •lack of sensation at the pelvic floor
- •being pregnant at the time of the examination
结局指标
主要结局
3D ultrasound images and pressure/volume measurements of vagina in patients with pelvic organ prolapse
时间窗: 1 hour and 20 minutes (i.e. the estimated time for the ultrasound and manometry examination per participant).
3D ultrasound images of the vaginal canal and the pelvic floor will be obtained using various ultrasound probes. Pressure and volume measurements (i.e. manometry) will be obtained using a urodynamic system.
次要结局
- Survey(5 minutes)