Prospective Multi-site Cohort Study Investigating Hysterectomy Versus Uterine Preservation for Pelvic Organ Prolapse Surgery: The HUPPS Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 321
- 试验地点
- 1
- 主要终点
- Anatomic failure to correct apical POP
研究概览
简要总结
Pelvic organ prolapse (POP) is the descent of pelvic organs into the vagina resulting in bulge symptoms and occurs in approximately 50% of women. Almost 20% of women will elect surgical correction of this condition by age 85. Removal of the uterus (hysterectomy) with concomitant vaginal vault suspension is a longstanding practice in POP surgery to address apical (uterine) prolapse. Yet, contemporary evidence on the merits of this approach relative to preservation of the uterus through suspension is needed to better inform surgical decision-making by patients and their healthcare providers. The objective of this trial is to evaluate POP-specific health outcomes and service utilization of women electing uterine suspension compared to those electing hysterectomy and vaginal vault suspension for POP surgery up to 1-year post-surgery.
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
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Have diagnosed POP of stage ≥2 using the globally recognized Pelvic Organ Prolapse-Quantification System (POP-Q)
- •Elect surgical management of POP
- •Demonstrate presence of apical prolapse on clinical exam deemed to require either a hysterectomy and concomitant vaginal vault suspension or uterine suspension to properly address their POP during surgical correction
- •Desire no further pregnancy
- •Can communicate in English
- •Are ≥18 years in age
排除标准
- •Prior hysterectomy
结局指标
主要结局
Anatomic failure to correct apical POP
时间窗: 1 year
Descent of the apex (POP-Q point C) equal to or beyond one half of the total vaginal length
次要结局
- Length of post-operative stay (days)(Peri-operative)
- Estimated blood loss during surgery >500 mL(Peri-operative)
- Opioid use in-hospital(Peri-operative)
- Resumption of spontaneous voiding (days)(Peri-operative)
- Subjective failure to correct POP(6 weeks; 1 year)
- Overall failure to correct POP(1 year)
- Length of surgery (minutes)(Peri-operative)
- Procedural complications(Peri-operative)
- PROM: Total POP Incontinence Sexual Questionnaire Revised (PISQ-IR) score(6 weeks; 1 year)
- Hospital readmission(30 days (any health complaint); 1 year (pelvic floor-related complaint))
- Post-operative infection(Peri-operative)
- PROM: Total Pelvic Floor Impact Questionnaire-7 (PFIQ-7) score(6 weeks; 1 year)
- Presentation at the emergency department(30 days (any health complaint); 1 year (pelvic floor-related complaint))
- PROM: Total Pelvic Floor Distress Inventory-20 (PFDI-20) score(6 weeks; 1 year)