Study of Uro-Tainer® Polihexanide and Uro-Tainer® With Citric Acid on Catheter Blockage, Infection Prevention, Cost-effectiveness and Quality of Life (UROBIQ): a Prospective Randomized Single-blinded Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Number of catheter changes during the treatment and follow-up period.
研究概览
简要总结
The purpose of the current study is to investigate whether catheter flushing with Uro-Tainer® with citric acid and Uro-Tainer® Polihexanide can: Reduce catheter changes due to incrustation and blockage.
In addition, a list of secondary aims inclusive of cost-effectiveness analysis in collaboration with the Centre for Innovative Medical Technology (CIMT) at OUH.
详细描述
The purpose of the current study is to investigate whether catheter flushing with Uro-Tainer® with citric acid and Uro-Tainer® Polihexanide can: Reduce catheter changes due to incrustation and blockage.
In addition, a list of secondary aims inclusive of cost-effectiveness analysis in collaboration with the Centre for Innovative Medical Technology (CIMT) at OUH.
There is a need for a randomised study to justify if Uro-Tainer® flushing will have an advantage over the cheaper and normally used Saline flushing.
Standard therapies vary depending on the blockage type and severity. Saline Solution can be used daily for a shorter period and 1-2 times a week for long-term catheter maintenance.
Study:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
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
- •Citizen not previously flushed
- •A permanent catheter (suprapubic and urethral)
- •Male and female > 18 years of age
- •Acute or previous catheter stop because of blocking or incrustations.
- •The pilot project does not include clogging due to incrustations
- •Voluntary consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the informed consent form approved by the Ethics Committee (EC) before all evaluations.
- •Citizen previously flushed with NaCl or UroTainer®
- •A permanent catheter (suprapubic and urethral)
- •Male and female > 18 years of age
- •Willingness to take a rinse break for a minimum of 4 weeks. In the event of 2 catheter stops during the flushing break, assessed on the basis of an urgent need for catheter flushing with NaCl or catheter change, the citizen can be included.
- •The pilot project does not include clogging due to incrustations
- •If there is no catheter stop during the rinsing break, the citizen will continue without rinsing until a possible catheter stop.
- •Voluntary consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the informed consent form approved by the Ethics Committee (EC) before all evaluations.
排除标准
- •Urothelial cancer
- •Bladder and kidney stones requiring treatment
- •Age < 18 years of age
- •Pregnant and / or breastfeeding women
- •Not able to understand Danish
- •Dementia, where relatives can / will not give consent
- •Simultaneous participation in another interventional clinical trial (drugs or medical devices studies)
研究组 & 干预措施
Uro-Tainer® catheter flushing
Uro-Tainer® catheter flushing two times weekly for 3 months.
干预措施: UroTainer® (Device)
Saline catheter flushing
Saline solution catheter flushing two times weekly for 3 months.
干预措施: Saline (Device)
结局指标
主要结局
Number of catheter changes during the treatment and follow-up period.
时间窗: 1 year
Number of catheter changes
次要结局
- Urine culture(1 year)
- Odour(1 year)
- Quality of life by SF-36(1 year)
- Quality of life by ICIQ-LTCqol(1 year)
- Cost effectiveness analyses 1(1 year)
- Cost effectiveness analyses 2(1 year)
- Cost effectiveness analyses 3(1 year)
- UTI events (Urinary tract infection event)(1 year)
- Urine culture(1 year)
- Odour(1 year)
- Quality of life by SF-36(1 year)
- Quality of life by ICIQ-LTCqol(1 year)
- Cost effectiveness analyses 1(1 year)
- Cost effectiveness analyses 2(1 year)
- Cost effectiveness analyses 3(1 year)
研究者
Karin Andersen
Principal Investigator
Odense University Hospital