A prospective, interventional, and multi-center study to characterize the efficacy and performance of the 100% Silicone Foley Balloon Catheter 2-way, 100% Silicone Foley Balloon Catheter – BH model 2-way, and 100% Silicone Foley Balloon Catheter – Star/ Ribbed model 2-way
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- The Secondary Endpoint is to evaluate the activation of periurethral gland is maintained during the catheter use and post catheterization by comparing the Star or Ribbed model and BH model.
研究概览
简要总结
**Title of Study-**A prospective, interventional, and multi-center study to characterize the efficacy and performance of the 100% Silicone Foley Balloon Catheter 2-way, 100% Silicone Foley Balloon Catheter – BH model 2-way, and 100% Silicone Foley Balloon Catheter – Star/ Ribbed model 2-way.
Purpose-The purpose of the study is to characterize the efficacy and performance of the 100% Silicone Foley Balloon Catheter (2-way without a cap, 100% Silicone Foley Balloon Catheter – BH model (2-way with cap), and 100% Silicone Foley Balloon Catheter – Star/ Ribbed model (2-way with cap).
Objective-
Primary objective-To assess the efficacy and performance by comparing all the 3 models 100% Silicone Foley Balloon Catheter, BH model, and Star model.
Secondary objective: To demonstrate the activation of periurethral gland is maintained during the catheter use and post catheterization by comparing the Star model and BH model.
Study Population- A sufficient number of subjects will be screened to recruit a total of 30 subjects in this study.
Inclusion/Exclusion Criteria-
| a) Inclusion Criteria |
- All subjects who undergo urinary catheterization indicated for long term catheterization of minimum of 30 days
- Both Male and Female patients will be enrolled
- All patients who are willing to provide informed consent for participation in the study
b) Exclusion Criteria
Subjects not suitable for intervention with silicone Foley catheter
All subjects who are not willing to provide informed consent for participation in the study
Pediatric population
Neurogenic bladder condition subjects
Immobilized subjects
Subjects having urethral strictures
Duration of study- Duration of study is 4 months.
Study Endpoints-
| Primary Endpoint: The Primary Endpoint is to demonstrate the efficacy and performance by comparing all the 3 models 100% Silicone Foley Balloon Catheters with cap and without cap. |
To determine the efficacy of the product:
To evaluate whether the catheters with cap gives any advantage of retaining the bladder functioning and bladder size in patients who are on catheter for 30 days or more.
To determine the performance of the product:
Reduction in CAUTI/ UTI in subject groups having catheter with cap (BH and star model) when compared with the subject group not having catheter with cap.
| Secondary Endpoint: The Secondary Endpoint is to evaluate the activation of periurethral gland is maintained during the catheter use and post catheterization by comparing the Star/ Ribbed model and BH model. |
To determine the activation of periurethral gland:
The physical verification by the investigator via ease of removal and ease of reinsertion of next catheter (if any). The investigator will rate the catheter based on VAS score based on user experience and patient comfort.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.All subjects who undergo urinary catheterization indicated for long term catheterization of minimum of 30 days 2.Both Male and Female patients will be enrolled 3.All patients who are willing to provide informed consent for participation in the study.
排除标准
- •1.Subjects not suitable for intervention with silicone Foley catheter 2.All subjects who are not willing to provide informed consent for participation in the study 3.Pediatric population 4.Neurogenic bladder condition subjects 5.Immobilized subjects 6.Subjects having urethral strictures.
结局指标
主要结局
The Secondary Endpoint is to evaluate the activation of periurethral gland is maintained during the catheter use and post catheterization by comparing the Star or Ribbed model and BH model.
时间窗: A minimum of 30 days after catheterization the activation of periurethral gland of the product will be assessed.
To determine the activation of periurethral gland The physical verification by the investigator via ease of removal and ease of reinsertion of next catheter (if any). The investigator will rate the catheter based on VAS score based on user experience and patient comfort.
时间窗: A minimum of 30 days after catheterization the activation of periurethral gland of the product will be assessed.
次要结局
- To demonstrate the activation of periurethral gland is maintained during the catheter use and post catheterization by comparing the Star model and BH model.(Duration of study is 4 months.)
研究者
Dr K S Shiva Kumar
Amar Jyothi Nursing Home and PMP Medical Centre