Cancer of the Uterus and Treatment of Stress Urinary Incontinence
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 556
- 试验地点
- 1
- 主要终点
- Clinical Outcomes- Surgical Outcomes
研究概览
简要总结
Concurrent treatment of endometrial cancer and SUI may improve QOL, emotional and physical health and decrease costs for both patients and the health care system. At the time of endometrial cancer diagnosis, not only are women evaluated by a gynecologist and/or a gynecologic oncologist, but the majority will undergo surgery within weeks of their diagnosis. Thus, urinary incontinence could easily be identified, a referral made, and concurrent surgery performed. This would spare the patient two surgeries, decrease the emotional distress associated with SUI symptoms, decrease the costs associated with SUI for the patient and possibly improve overall quality of life. The proposed study will compare the quality of life and clinical outcomes among women with endometrial cancer and SUI that have concurrent surgery to women that do not have concurrent surgery. The findings of our proposed research will provide valuable information necessary for woman and clinicians to make decisions regarding the treatment of SUI, including evidence regarding the risks and benefits of performing concurrent endometrial cancer and SUI 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 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women will be eligible if they have:
- •clinical stage 1 or 2 (disease confined to the uterus) endometrial carcinoma or complex atypical hyperplasia
- •answer yes to one screening question: "Do you ever leak urine when you cough, sneeze, jump or laugh?" We will include women with complex atypical hyperplasia (CAH) because 40% of these women will have an endometrial cancer identified at the time of surgery and the risk factors are the same for CAH as they are for clinical stage 1 and 2 endometrial cancers
排除标准
- •Women will be excluded if they have
- •clinical stage 3 and 4 endometrial cancer
- •prior pelvic radiation therapy
- •vesicovaginal fistula
- •urethrovaginal fistula.
- •We are excluding women with vesicovaginal fistula or urethrovaginal fistula due to the risk of infection when placing a midurethral sling.
结局指标
主要结局
Clinical Outcomes- Surgical Outcomes
时间窗: Pre-op to 12 month post-op
Compare the clinical outcomes of women with endometrial cancer and SUI who have concurrent surgery to women who have cancer surgery only by examining surgical outcomes such as intra op injuries or complications using hospital records.
Sexual Function will be measured using the female sexual function index (FSFI)
时间窗: Pre-op to 12 month post-op
Compare the sexual function of women with endometrial cancer and SUI who have concurrent surgery to women who have cancer surgery only. Sexual function will be measured using the female sexual function index (FSFI). It is a 19-item instrument assessing 6 domains of sexual function: desire, arousal, lubrication, orgasm, satisfaction, and pain.
Quality of Life
时间窗: Pre-op to 12 month post-op
The purpose of this study is to compare quality of life among women with endometrial cancer and SUI who undergo SUI and endometrial cancer surgery simultaneously to women that do not.
Clinical Outcomes- Time to Surgery
时间窗: Enrollment to Day of Surgery
Compare the clinical outcomes of women with endometrial cancer and SUI who have concurrent surgery to women who have cancer surgery only, by measuring time to surgery (ie: number of days) using hospital records. The estimated time to surgery will be assessed up to 12 weeks, measuring from initial date of enrollment to date of documented surgery date.
Clinical Outcomes- Post-Operative Complications
时间窗: Pre-op to 12 month post-op
Compare the clinical outcomes of women with endometrial cancer and SUI who have concurrent surgery to women who have cancer surgery only by examining Post-Operative complications. We will document any treatment-related adverse events as assessed by CTCAE v4.0. We will use hospital records.
次要结局
- Sling Complications(Pre-op to 12 month post-op)
- Post- Operative Pain(Day 1 in hospital after surgery)
研究者
Katina Robison
MD
Women and Infants Hospital of Rhode Island