Lower Urinary Tract Symptoms After Intravesical Therapy With Mitomycin C or BCG in Patients With Carcinoma of the Bladder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Effect of instillation therapy on lower urinary tract symptoms
研究概览
简要总结
With this prospective, observational study, we would like to investigate the effect of instillation therapy using BCG or mitomycin C on short- and long-term irritative and obstructive lower urinary tract symptoms using validated questionnaires. The study will objectify the lower urinary tract symptoms and thereby provide better recommendations for therapy with mitomycin C or BCG.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Urinary bladder carcinoma requiring instillation therapy
- •Complete resection of the tumor
- •No intravesical chemotherapy in the last 3 months
排除标准
- •Patients who are unable to complete the questionnaires
- •Patients who are not willing to participate
- •Patients with contraindications for instillation therapy (allergic reactions, immunosuppression)
结局指标
主要结局
Effect of instillation therapy on lower urinary tract symptoms
时间窗: During the study period approximately 12 months
Lower urinary tract symptoms will be measured with validated questionnaires such as the BPIC-SS, the ICIQ-MLUTS (men) and the ICIQ-FLUTS (women)
Effect of instillation therapy on sexuality
时间窗: During the study period approximately 12 months
Sexuality will be measured with validated questionnaires such as the IIEF-EF (men) and the FSFI (women)
Effect of instillation therapy on quality of life
时间窗: During the study period approximately 12 months
Quality of life will be measured with validated questionnaires such as the ICIQ-OABqol
次要结局
- Complications during instillation therapy(During the study period approximately 12 months)
- Discontinuation rate of instillation therapy(During the study period approximately 12 months)
研究者
Benedikt Ebner
Dr. med.
Ludwig-Maximilians - University of Munich