Prospective, randomised controlled trial of using catheter valve
Research type
Research Study
Full title
A prospective, multicenter, randomized trial : The effect of catheter valve Vs. standard catheter removal in outpatient settings on the patient discharge timings.\n
IRAS ID
191435
Contact name
Shikohe Masood
Contact email
Sponsor organisation
Medway NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
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 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. \nThe 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. \nIn 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.\nThis study will last for one year after approval by ethical committee.\nThe 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.
REC name
London - London Bridge Research Ethics Committee
REC reference
16/LO/0075
Date of REC Opinion
10 Feb 2016
REC opinion
Further Information Favourable Opinion