NCT02294383已完成不适用
Vaginal Tactile Imaging in Assessment of Pelvic Floor Conditions
Artann Laboratories2 个研究点 分布在 1 个国家目标入组 138 人开始时间: 2014年8月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 138
- 试验地点
- 2
- 主要终点
- Tissue elasticity measured as a gradient in tactile image. Unit of Measure: kPa/mm
研究概览
简要总结
The clinical study includes investigation of the outcomes of surgery for biomechanical restoration of pelvic floor conditions, monitoring pelvic floor conditions under conservative treatment/management, identification and investigation changes of pelvic floor muscle contractions and their significance in characterization of pelvic floor conditions, assessment of tactile imaging reproducibility, including pelvic floor muscle contraction.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •No prior pelvic floor surgery, and
- •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 measured as a gradient in tactile image. Unit of Measure: kPa/mm
时间窗: From 1 day to 12 months
次要结局
未报告次要终点
研究者
研究点 (2)
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