Sexual Function in Women After Radical Cystectomy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Mayo Clinic
- 入组人数
- 34
- 主要终点
- Lubrication
研究概览
简要总结
This study evaluates the general physical, emotional, and sexual function in women undergoing a radical cystectomy for bladder cancer. A radical cystectomy is a surgical procedure that involves the removal of the bladder, uterus, ovaries, fallopian tubes, and part of the vagina. This may affect sexual function in women. This study seeks to understand how radical cystectomy alters sexual function and well-being, and what factors may affect this change.
详细描述
PRIMARY OBJECTIVES:
I. To characterize pre-operative sexual function and interest in sexual activity of women undergoing radical cystectomy.
II. To identify patient understanding and expectations as they relate to sexual dysfunction after radical cystectomy.
III. To describe pre-operative importance in sexual function recovery after radical cystectomy.
IV. Quantify the changes in sexual function within the year following radical cystectomy in women.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult women greater than 18 years of age
- •A diagnosis of bladder cancer
- •Planned to undergo a radical cystectomy
- •Willing and able to complete survey questionnaires
排除标准
- •Inability to provide informed consent
- •Non-English speaking
- •Life expectancy less than 2 years
结局指标
主要结局
Lubrication
时间窗: From baseline to 3, 6, and 12 months
Will descriptively summarize the within-patient changes using the PROMIS Brief Profile Sexual Function and Satisfaction v2.0. Contrasts within the linear mixed effects model will compare changes in subdomain score between different time points.
Preoperative sexual function
时间窗: Baseline
Assessed using the Patient Reported Outcomes Measurement Information System (PROMIS) Brief Profile Sexual Function and Satisfaction version 2 (v2.0). Will utilize descriptive statistics to report preoperative sexual function. Frequencies and percentages will be reported for categorical variables and mean (standard deviation) or median (interquartile range) for continuous variables.
Interest in sexual activity
时间窗: From baseline to 3, 6, and 12 months
Will descriptively summarize the within-patient changes using the PROMIS Brief Profile Sexual Function and Satisfaction v2.0. Contrasts within the linear mixed effects model will compare changes in subdomain score between different time points.
Vaginal discomfort
时间窗: From baseline to 3, 6, and 12 months
Will descriptively summarize the within-patient changes using the PROMIS Brief Profile Sexual Function and Satisfaction v2.0. Contrasts within the linear mixed effects model will compare changes in subdomain score between different time points.
Satisfaction with sex life
时间窗: From baseline to 3, 6, and 12 months
Will descriptively summarize the within-patient changes using the PROMIS Brief Profile Sexual Function and Satisfaction v2.0. Contrasts within the linear mixed effects model will compare changes in subdomain score between different time points.
次要结局
- Labial discomfort(From baseline to 3, 6, and 12 months)
- Orgasm pleasure(From baseline to 3, 6, and 12 months)
- Change in sexual function scores(From baseline to 12 months)
- Orgasm ability(From baseline to 3, 6, and 12 months)
- Clitoral discomfort(From baseline to 3, 6, and 12 months)
研究者
Stephen A. Boorjian, M.D.
Principal Investigator
Mayo Clinic