A Randomized, Blinded, Controlled Crossover Trial Evaluating Effectiveness of NowCath Foley in Reducing Catheter-Associated Urinary Tract Infections and Blockages in Long-Term Indwelling Catheter Users
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 3
- 主要终点
- Incidence of catheter changes per 100 catheter days during the first 4 weeks of each treatment phase
研究概览
简要总结
People who rely on long-term indwelling urinary (Foley) catheters often experience recurrent urinary tract infections and catheter blockages that require unscheduled catheter changes, additional antibiotics, and emergency visits. These complications reduce quality of life and increase healthcare use.
The NowCath Foley is an all-silicone indwelling urinary catheter with two additional drainage eyelets positioned below the retention balloon. A thin silicone skirt covers the eyelets to reduce suction against the bladder wall. The design is intended to improve bladder emptying and reduce mucosal contact, which may in turn lower the rate of catheter-associated urinary tract infections (CAUTIs) and blockages compared with a conventional all-silicone Foley catheter.
The REDUCE study is a multi-centre, randomized, blinded, controlled crossover clinical investigation conducted in Denmark. The primary goal is to determine whether the NowCath Foley catheter can reduce incidence of CAUTI over 12 weeks compared to a conventional long-term indwelling Foley catheter in an adult population using indwelling urethral or suprapubic Foley catheters . The participants (n=160) are cared for and enrolled by community nursing services in the Ikast-Brande and Holstebro municipalities in collaboration with the coordinating site at Regional Hospital Gødstrup. Each participant will use both the NowCath Foley and a conventional all-silicone Foley catheter (Rüsch Brillant, Teleflex Medical) in a randomized sequence, for 12 weeks each (24 weeks total).
The primary outcome is the rate of catheter changes per 100 catheter days. Secondary outcomes include CAUTI incidence, blockage incidence, residual urine volume, encrustation, antibiotic use, quality of life, patient comfort, safety, and cost-effectiveness.
During phase 1, participants will be randomised to either NowCath or the conventional Foley catheter and will be seen at weeks 0 and 12. At week 12 participants will be crossed-over to phase 2, where they will receive the other catheter not allocated in phase 1 and will be seen at weeks 12 and 24. As the participants would default to the comparator catheter as part of standard of care, the wash-out period is minimal.
详细描述
Background Adults who depend on long-term indwelling urethral or suprapubic Foley catheters in the community setting frequently experience catheter-associated urinary tract infections (CAUTIs), catheter blockages, and unscheduled catheter changes. These complications are associated with increased antibiotic exposure, hospital and emergency visits, morbidity, and impaired quality of life. Antimicrobial coatings and other design modifications tested to date have shown limited long-term benefit. Two of the pathophysiological drivers of these complications are incomplete bladder emptying, which leaves a residual reservoir that supports bacterial growth and crystalline precipitation, and mucosal contact with the drainage eyelets, which can cause local trauma and inflammation.
Investigational Device
The NowCath Foley is an all-silicone indwelling urinary catheter conforming to ISO 20696 and ASTM F623. It differs from a conventional all-silicone Foley catheter in two respects: two additional drainage eyelets positioned below the retention balloon, and a thin flexible silicone skirt that covers these eyelets to reduce mucosal suction. The device is intended for long-term (up to 90 days) indwelling urethral or suprapubic use.
Comparator A commercially available, CE-marked all-silicone Foley catheter (Rüsch Brillant, Teleflex Medical) representing the current standard of care.
Regulatory Framework The study is a pre-market pivotal clinical investigation conducted under Regulation (EU) 2017/745 (MDR) in accordance with ISO 14155:2020 and the Declaration of Helsinki. A clinical evaluation concluded that additional clinical data are required to confirm compliance with the relevant General Safety and Performance Requirements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Participants, treating physicians, and community-nursing personnel are blinded to catheter allocation through identical over-labelling of both catheter types. Study coordinators and the Principal Investigator are unblinded for safety monitoring and logistical oversight. Blinding integrity is assessed at week 24 with a participant questionnaire.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older
- •Indwelling urethral or suprapubic Foley catheter in place for at least 28 days prior to enrolment
- •Expected need for continued indwelling catheterization for at least 6 months
- •No systemic antibiotic treatment for CAUTI within 48 hours prior to enrolment
- •Written informed consent provided by the participant
- •Receiving community nursing care from Ikast-Brande or Holstebro municipalities (or otherwise cared for by their services)
排除标准
- •Known allergy or hypersensitivity to silicone or glycerin
- •Straight-tip catheterization considered clinically unsuitable
- •Planned continuation of prophylactic antibiotics for frequent CAUTI
- •Ureteric stents in place or planned genito-urinary procedures during the study period
- •Pregnancy, lactation, or planned pregnancy during the study period
研究组 & 干预措施
Sequence A: NowCath Foley → Conventional Foley
Participants receive the NowCath Foley catheter during weeks 0-12, followed by a scheduled catheter change to the conventional all-silicone Foley catheter for weeks 12-24.
干预措施: NowCath Foley (Device)
Sequence A: NowCath Foley → Conventional Foley
Participants receive the NowCath Foley catheter during weeks 0-12, followed by a scheduled catheter change to the conventional all-silicone Foley catheter for weeks 12-24.
干预措施: Conventional All-Silicone Foley Catheter (Device)
Sequence B: Conventional Foley → NowCath Foley
Participants receive the conventional all-silicone Foley catheter during weeks 0-12, followed by a scheduled catheter change to the NowCath Foley catheter for weeks 12-24.
干预措施: NowCath Foley (Device)
Sequence B: Conventional Foley → NowCath Foley
Participants receive the conventional all-silicone Foley catheter during weeks 0-12, followed by a scheduled catheter change to the NowCath Foley catheter for weeks 12-24.
干预措施: Conventional All-Silicone Foley Catheter (Device)
结局指标
主要结局
Incidence of catheter changes per 100 catheter days during the first 4 weeks of each treatment phase
时间窗: Weeks 0-4 and weeks 12-16 (first 4 weeks of each 12-week phase)
Number of catheter changes (for any reason: CAUTI, blockage, dislodgement, or other) per participant during the first 4 weeks of each 12-week catheter phase, normalized to per 100 catheter days. Compared between catheter types using within-participant paired analysis.
Incidence of catheter changes per 100 catheter days over the full 12-week treatment phase
时间窗: Weeks 0-12 and weeks 12-24 (full 12 weeks of each phase)
Number of catheter changes per participant during the full 12-week phase, normalized to per 100 catheter days. Compared between catheter types using within-participant paired analysis.
次要结局
- Catheter-related quality of life (ICIQ-LTCqol)(Weeks 0, 12, and 24)
- General health-related quality of life (EQ-5D-5L)(Weeks 0, 12, and 24)
- Residual urine volume(Weeks 12 and 24)
- Time to first asymptomatic bacteriuria(Weeks 0-24)
- Incidence of catheter-associated urinary tract infection (CAUTI) per 100 catheter days(Weeks 0-12 and weeks 12-24)
- Incidence of catheter blockage requiring catheter removal per 100 catheter days(Weeks 0-12 and weeks 12-24)
- Catheter encrustation severity(At each catheter removal (weeks 12, 24, and unscheduled removals))
- Antibiotic use(Weeks 0-24)
- Within-trial cost-effectiveness(Weeks 0-24)
- Study-coordinator-reported ease of catheter insertion(At each catheter insertion (weeks 0, 12, and unscheduled))
- Participant preference between catheters(Week 24)