Vaginal Tactile Imaging in Assessment of Pelvic Floor Conditions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 119
- 试验地点
- 5
- 主要终点
- Tissue elasticity change after the surgery measured as a gradient in tactile image. Unit of measure: mmHg/mm
研究概览
简要总结
The investigators will analyze biomechanical transformation of pelvic floor tissues and support structures under affected pelvic floor conditions and repaired states after the surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subject is female of 21 years or older, and
- •No prior pelvic floor surgery, and
- •One of the following:
- •Normal pelvic floor conditions, or POP Stage I affecting one or more vaginal compartment, or POP Stage II affecting one or more vaginal compartment, or POP Stage III affecting one or more vaginal compartment, or POP Stage IV affecting one or more vaginal compartment
排除标准
- •Active skin infection or ulceration within the vagina
- •Presence of a vaginal septum;
- •Active cancer of the colon, rectum wall, cervix, vaginal, uterus or bladder;
- •Ongoing radiation therapy for pelvic cancer;
- •Impacted stool;
- •Significant pre-existing pelvic pain including levator ani syndrome, severe vaginismus or vulvadynia;
- •Severe hemorrhoids;
- •Significant circulatory or cardiac conditions that could cause excessive risk from the examination as determined by attending physician;
- •Current pregnancy.
结局指标
主要结局
Tissue elasticity change after the surgery measured as a gradient in tactile image. Unit of measure: mmHg/mm
时间窗: pre-surgery and post-surgery (4-6 months after surgery) measurements
Tissue elasticity is measured for entire anterior and posterior compartments
Pelvic floor muscle strength change after the surgery measured as a pressure dynamic feedback during muscle contractions. Unit of measure: mmHg
时间窗: pre-surgery and post-surgery (4-6 months after surgery) measurements
Muscle strength is measured during voluntary and involuntary muscle contractions, involuntary relaxation and Valsalva maneuver.
次要结局
未报告次要终点