Investigating the Correlation Between the Brain and Pelvic Floor Muscle Activity of Patients Who Had or Are Undergoing Robot-Assisted Radical Prostatectomy
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Pelvic floor muscle (PFM) EEG measures
研究概览
简要总结
This trial investigates brain and pelvic floor muscle activity in patients undergoing robot-assisted radical prostatectomy. This trial may help identify the brain waves that are associated with muscles involved in giving patients control over the bladder.
详细描述
PRIMARY OBJECTIVES:
- Identify pelvic floor muscle (PFM) activity on electromyogram (EMG) and electroencephalography (EEG).
- Identify any synchrony in EMG and EEG for PFM activity.
- Identify any relationship between EEG activity and UDS findings.
SECONDARY OBJECTIVES:
I. Identify changes in EEG and EMG activity with Kegel exercise. II. Examine relationship between EEG activity and continence.
EXPLORATORY OBJECTIVE:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Adults who had or are undergoing robot-assisted radical prostatectomy (RARP)
- •Must be continent preoperatively
- •Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
排除标准
- •Unwilling or unable to follow protocol requirements
- •Any condition which in the Investigator's opinion deems the participant an unsuitable candidate for study participation
研究组 & 干预措施
Supportive Care (brain and muscle monitoring, questionnaire)
Patients perform standard of care Kegel exercises while undergoing brain and muscle activity monitoring by UDS, EEG and EMG, respectively, before surgery, 6 weeks after surgery, and at 3, and 6 months after surgery. Patients complete questionnaires over 5-10 minutes about urinary function
干预措施: Electroencephalography (Procedure)
Supportive Care (brain and muscle monitoring, questionnaire)
Patients perform standard of care Kegel exercises while undergoing brain and muscle activity monitoring by UDS, EEG and EMG, respectively, before surgery, 6 weeks after surgery, and at 3, and 6 months after surgery. Patients complete questionnaires over 5-10 minutes about urinary function
干预措施: Electromyography (Procedure)
Supportive Care (brain and muscle monitoring, questionnaire)
Patients perform standard of care Kegel exercises while undergoing brain and muscle activity monitoring by UDS, EEG and EMG, respectively, before surgery, 6 weeks after surgery, and at 3, and 6 months after surgery. Patients complete questionnaires over 5-10 minutes about urinary function
干预措施: Questionnaire Administration (Other)
Supportive Care (brain and muscle monitoring, questionnaire)
Patients perform standard of care Kegel exercises while undergoing brain and muscle activity monitoring by UDS, EEG and EMG, respectively, before surgery, 6 weeks after surgery, and at 3, and 6 months after surgery. Patients complete questionnaires over 5-10 minutes about urinary function
干预措施: Urodynamics (UDS) (Procedure)
结局指标
主要结局
Pelvic floor muscle (PFM) EEG measures
时间窗: Up to 6 months
Simultaneous recordings of brain activity using electrodes attached to the scalp and muscle activities of muscles of the anal sphincter with electrodes bonded to the skin.
EEG measures obtained during urination.
时间窗: Up to 6 months after surgery
Recordings of brain and muscle activity will be collected during urination
Identification of Areas of synchrony in EEG Patterns and associated Urodynamics (UDS) findings
时间窗: UP to 6 months
UDS data of Incontinence/continence will be monitored along with EEG recordings of brain activity during urination.
次要结局
- Improvement of continence(Throughout life of study up to 6 months after surgery)
- EEG and EMG biofeedback(Up to 6 months)