Neuroimaging Study of Supraspinal Control of Lower Urinary Tract Function in Patients with Orthotopic Sigmoid Neobladder.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The peak T-value size of the activation region
研究概览
简要总结
Orthotopic sigmoid neobladder surgery is one of the ideal urinary diversion methods after radical cystectomy.In recent years, functional imaging studies have revealed brain regions related to urinary system function, but brain activity of lower urinary tract function in neobladder patients is still unclear.The aim of this study is to explore the brain activity of urination intention and self-controlled urination behavior in patients with orthotopic sigmoid neobladder by task-state functional magnetic resonance imaging (fMRI).
研究设计
- 研究类型
- 观察性
- 观察模型
- 队列研究
- 时间视角
- 横断面
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- Being right-handed;
- 3 months or more after operation;
- No contraindications to fMIR examination;
- Voluntarily sign informed consent.
排除标准
- History of bladder radiotherapy;
- History of prostate cancer;
- Suffering from diseases affecting abdominal pressure;
- History of abnormal brain anatomy, craniocerebral surgery, craniocerebral tumor, and craniocerebral radiotherapy;
- History of mental disorders, Parkinson's disease, Alzheimer's disease, epilepsy, cerebral infarction, cerebral hemorrhage;
- Claustrophobia or carrying metal implants that are not suitable for fMRI examination;
- Diseases affecting lower urinary tract function (such as spinal cord injury, diabetic peripheral neuropathy, etc.);
- Urethral stricture;
- Refusing to sign the informed consent form for clinical projects;
- Other conditions that were not suitable for inclusion according to the investigator's judgment.
结局指标
主要结局
The peak T-value size of the activation region
时间窗: 3 months
Peak T values of activated or inhibited regions of the brain in fMRI images
The location of brain functional activation areas
时间窗: 3 months
Areas of the brain where excitation or inhibition occurs in fMRI images
次要结局
未报告次要终点
研究者
Chunxiao Liu
Professor;Chief Surgeon
Zhujiang Hospital
研究点 (1)
标识符
- NCT 编号
- NCT05558111
- 其他研究编号
- 2022-KY-131-02
日期
- 首次提交
- (4年前)
- 首次发布
- (4年前)
- 主要完成日期
- (去年)
- 研究完成日期
- (去年)
- 最近核实
- 最近更新
- (去年)
监管与共享
- FDA 监管药物
- 否
- 是否有结果
- 否