CTRI/2024/11/076710尚未招募2 期
A Clinical Study to Evaluate the Performance and Safety of the Urine Leak Capture, Flow Capture Device in Comparison to standard medical practice administered along with Pelvic Floor Exercises among Males requiring Urinary Incontinence management-A Randomized Controlled Trial
Melarkode Krishnan Ramkumar6 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2024年11月25日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 135
- 试验地点
- 6
- 主要终点
- Performance of the product like security, confidence, ease of use, leak prevention, and application difficulty will be analyzed using a 2-point scale validated questionnaire
研究概览
简要总结
A Clinical Study to Evaluate the Performance and Safety of the Urine Leak Capture, Flow Capture Device in Comparison to standard medical practice administered along with Pelvic Floor Exercises among Males requiring Urinary Incontinence management-A Randomized Controlled Trial
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Male
入选标准
- •1.Male subjects aged above 18 years.
- •2.Subjects with history of urine incontinence.
- •3.Subjects with UI (7 episodes/week) and frequency (8 micturition/day).
- •4.Subjects must be Ambulatory.
- •5.Subjects who are able to practice the intervention as per the guideline.
- •6.Subjects who are likely to come for follow up 7.Subjects willing to give their informed consent.
排除标准
- •1.Current urinary tract infection or history of more than 3 urinary tract infections per year 2.Incontinence due to fistula (bladder or rectum) 3.Symptomatic pelvic organ prolapse.
- •4.BMI greater than 35 kg/m2 5.Congenital defects leading to incontinence.
- •6.Already engaged in any clinical trial 7.Subjects with bladder outlet obstruction 8.Subjects with latex allergy.
结局指标
主要结局
Performance of the product like security, confidence, ease of use, leak prevention, and application difficulty will be analyzed using a 2-point scale validated questionnaire
时间窗: six months
次要结局
- The performance of the product like ease of wearing and removing the product, comfort, ease of attaching the device to a leg bag, ease of following instructions, and tracking the overall opinion will be analyzed using 3 -point scale validated questionnaire(Six months)
研究者
Dr Vipul Chakurkar
KEM Hospital Research Centre
研究点 (6)
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