A Prospective, Multicenter, Randomized Trial: The Effect of Catheter Valve Vs. Standard Catheter Removal in Outpatient Settings on the Patient Discharge Timings
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Time to spontaneous void after catheter removal
研究概览
简要总结
It is estimated that over 10% of men above the age of 60 will experience an episode of urinary retention over a period of 5 years and will need urethral catheter. Some of these patients are discharged from the hospital with urethral catheter, for them to attend a Trial Without Catheter (TWOC) clinic at a later date for catheter removal. Traditionally after catheter is removed in the clinic the nurse has to wait for up to 5 hours before the patient get the urge to pass urine and empty the bladder.
The main objective of this study is to see the effect of catheter valve on the length of clinic stay (timing of discharge)for the patients (men age 60-85) after catheter is removed.
In this study after randomization, patients in Group A (catheter valve group) will be given a catheter valve before they are sent home with the catheter.They will be asked to close the valve 3-4 hours (time required for adequate filling of bladder, which means minimum of 250 mls in bladder with natural filling) before their appointment. It is very likely that by the time these patients are seen in the TWOC clinic their bladder is already full and they will void soon after removal of catheter.The patients in Group B (control) will go home with free drainage catheter and urine bag (standard catheter removal). These patients on arrival, in the TWOC clinic will have an empty bladder when their catheter is removed, they will then drink plenty of fluids in the clinic and wait for their bladder to be full before they void spontaneously.
This study will last for one year after approval by ethical committee.
The time saved in this process would lessen patient anxiety, lead to more patients being reviewed in clinic and therefore reduced waiting times in TWOC clinics and will save money.
详细描述
Men who are discharged from the hospital with urinary catheter in situ are given an appointment to come to trial TWOC (trail without catheter) clinic for removal of their catheters.
Purpose and design:
In the TWOC clinic their catheters are removed and they usually wait for up to 5 hours hours before they get an urge to pass urine and empty the bladder and then sent home by the nurse. Waiting for up to 5 hours in the clinic reduces patient satisfaction and increases their anxiety. It also keeps the urology nurse busy in the clinic. This is shown by a clinical audit, which has been carried out in our department.
The aim of this study is to find out the ways to reduce this waiting time for the patients. In this study catheter valve is used to see if it significantly reduces time spent by the patient in the TWOC clinic after catheter removal. The patients in the catheter valve group are compared to the patients who did not use the valve (this is the standard method which is currently used by most of the TWOC clinics).
Catheter valve is a device, which is attached to the end of urinary catheter and can be used easily by any one who has normal manual dexterity and no cognitive impairment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men aged 60-85 catheterised for urinary retention and booked for outpatient removal of catheter
- •Mobile patients
排除标准
- •Who cannot consent
- •Residual urine of more then 1 litre
- •Abnormal renal functions
- •Poor manual dexterity
- •Learning difficulties/dementia.
研究组 & 干预措施
Without valve
Trial removal of catheter without catheter valve in patients with urinary retention. These are those patients who have catheter on free drainage, attend the clinic for catheter removal and bladder to be filled naturally ( which may take upto 4-5 hours). After removal of catheter they will be asked to drink plenty of fluids while waiting for the bladder to fill up.
This is the traditional method of catheter removal.
干预措施: Trial removal of catheter in patients with urinary retention (Procedure)
With valve
Trial removal of catheter in patients with urinary retention with closed catheter valve. These patients will be asked to close the valve 3-4 hours before attending the clinic prior to catheter removal. Here the intervention is catheter valve that allows bladder to be comfortably full by the time patient arrives in the clinic. By this intervention the investigators hypothesise that the investigators can save the clinic time as the patient will not need to wait for natural bladder filling which generally takes 4-5 hours.
Intervention: Urinary catheter valve
干预措施: Use of catheter valve before 'trial removal of catheter' (Procedure)
结局指标
主要结局
Time to spontaneous void after catheter removal
时间窗: On the day of catheter removal
The primary outcome measure of this study is to see if usage of catheter valve results in early spontaneous voiding after catheter removal and thus significantly reduces the time spent by these patients in the clinic.
次要结局
- Reduction in the cost of running the clinic(On the day of catheter removal)
- Complications associated with valve(On the day of catheter removal)
- Reduction in clinic waiting time (hours)(On the day of catheter removal)
研究者
Shikohe Masood
Consultant Urological Surgeon
Medway NHS Foundation Trust