Pelvic Floor Muscles Efficiency as an Independent Factor of Therapeutic Success in the Surgical Treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Pelvic floor organ prolapse quantification (POP-Q)
研究概览
简要总结
The aim of the study is evaluation of the efficiency of pelvic floor muscles in the context of surgical outcomes in the treatment of stress urinary incontinence and pelvic organ prolapse.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •premenopausal and postmenopausal women
- •stress urinary incontinence
- •pelvic organ prolapse
排除标准
- •previous surgical interventions due to stress urinary incontinence or pelvic organ prolapse
结局指标
主要结局
Pelvic floor organ prolapse quantification (POP-Q)
时间窗: change from the baseline till 6 month post treatment
Quantification of pelvic organ prolapse, range 0-4, higher indicate worse outcomes
Marshall-Bonney test
时间窗: change from the baseline till 6 months post treatment
Assessment of stress urinary incontinence, test can be negative or positive, positive test indicates incontinence
Pelvic Floor Distress Inventory (PFDI-20)
时间窗: change from the baseline till 6 months post treatment
Symptom inventory and a measure of the degree of bother and distress. The PFDI-20 includes 20 questions and 3 scales. Each of the 3 scales is scored from 0 (least distress) to 100 (greatest distress). The sum of the scores of these 3 scales serves as the overall summary score of the PFDI-20 and ranges from 0 - 300.
次要结局
- Pelvic floor organ prolapse quantification (POP-Q)(6 months post treatment)
- PELVIC FLOOR IMPACT QUESTIONNAIRE SHORT FORM (PFIQ-7)(change from the baseline till 12 months post treatment)
- Pelvic Floor Distress Inventory (PFDI-20)(6 months post treatment)
- Marshall-Bonney test(6 months post treatment)
- Visual Analogue Scale(change from the baseline till 12 months post treatment)
- Incontinence impact Questionnaire-Short Form (IIQ-7 SF)(change from the baseline till 12 months post treatment)