jRCT1040230024进行中（未招募）不适用
Evaluation of the IS-01, a new device for urinary care in male patients with urinary incontinence. (IS-01)
Shigeo Imai0 个研究点目标入组 10 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 10
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Health Services Research
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- Male
入选标准
- •Patients who are expected to have persistent urine leakage after robot-assisted total prostatectomy at Kanazawa University Hospital
- •(2) Patients attending the outpatient clinic of the Department of Urology at Kanazawa University Hospital who have been using urine pads or diapers at least 1 piece/day for at least 6 months.
排除标准
- •(1) Patients who cannot give written informed consent for this study
- •(2) Patients who cannot wear the IS-01 by themselves due to medical reasons such as paralysis of the upper limbs or cognitive impairment
- •(3) Patients who are considered unfit to use the IS-01 for medical reasons such as severe skin diseases
- •(4) Patients who have difficulty completing the questionnaire
- •(5) Other patients deemed inappropriate as research subjects by the investigators
结局指标
主要结局
-
Evaluation of usability (total score of questionnaire evaluation) by "IS-01 Usage Questionnaire".
次要结局
- Change in ICIQ-SF over time(2, 4, and 12 weeks)
- Comparison of the number of pads used daily
- Number of pads used daily
研究者
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