The Effect of Catheter Valve Vs. Standard Catheter Removal in Outpatients
The Effect of Catheter Valve Vs. Standard Catheter Removal in Outpatients
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.
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.

 The study proposal was developed by lead urology nurse practitioner and endorsed by the
 consultant urological surgeons from three different hospitals in Kent UK (Medway Maritime
 Hospital, Darent Valley Hospital and Maidstone Hospital).

 Recruitment:

 Patients will be identified and recruited in the hospital ward. The patients who are planned
 to go home with the catheter will be provided with the patient information leaflet about his
 study. They will be given 6 hours to decide if they want to participate in this study. Those
 patients who agree to participate will be asked to sign a written informed consent. A
 computer-generated randomisation will be carried out. They will be given a contact number of
 the urology nurse in case they have any problems or if they want to ask any questions before
 attending TWOC clinic.

 A day after discharge urology nurse practitioner will ring the patient at home to check if
 the patient still wants to participate in this study. A day before their appointment for TWOC
 clinic urology nurse will ring the patient (in Group A, valve group) to remind him about the
 appointment and also remind him to close the valve 3-4 hours before appointment time and
 patients in both groups (Group A and Group B) to drink three glasses of water before coming
 to the hospital for catheter removal. Patients will be informed that they can withdraw from
 the study at any point.

 Inclusion and exclusion:

 A strict inclusion and exclusion criteria will be observed. Vulnerable men with learning
 difficulties/dementia/Alzheimer's disease or those with poor manual dexterity will not be
 included.

 Consent:

 Written informed consent will be used after patients has read the patient information leaflet
 and the study has been verbally explained to the patient by the researchers.

 Risks, burdens and benefits

 There is no potential risk to the patients associated with the planned intervention.The
 vulnerable adults with learning difficulties/Dementia and poor manual dexterity will be
 excluded. In the intervention arm (GROUP A: patient with valve) the patient may get a pain
 with strong desire to pass urine or start bypassing catheter much before 3 hours after
 closing the valve. In this case patients will be instructed to open the valve and drain the
 urine. (These patients will be excluded).

 If there is significant reduction (one hour or more) in the time spent in the clinic for the
 valve group noted in this study that will help in decreasing patient's anxiety, improved
 efficacy of the TWOC clinic and reduce the cost of running the TWOC clinic.

 Confidentiality:

 The data will be recorded electronically and will be saved in a password protected computer.
 The researchers and statistician can only access it.

 Conflict of interest:

 There is no conflict of interest. All the researchers will sign the form.
Inclusion Criteria:

 -  Men aged 60-85 catheterised for urinary retention and booked for outpatient removal of
 catheter

 -  Mobile patients

 Exclusion Criteria:

 -  Who cannot consent

 -  Residual urine of more then 1 litre

 -  Abnormal renal functions

 -  Poor manual dexterity

 -  Learning difficulties/dementia.