The Effect of Catheter Valve Vs. Standard Catheter Removal in Outpatients
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|ClinicalTrials.gov Identifier: NCT02717975|
Recruitment Status : Unknown
Verified March 2016 by Shikohe Masood, Medway NHS Foundation Trust.
Recruitment status was: Recruiting
First Posted : March 24, 2016
Last Update Posted : March 28, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Urinary Retention||Procedure: Use of catheter valve before 'trial removal of catheter' Procedure: Trial removal of catheter in patients with urinary retention||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Multicenter, Randomized Trial: The Effect of Catheter Valve Vs. Standard Catheter Removal in Outpatient Settings on the Patient Discharge Timings|
|Study Start Date :||March 2016|
|Estimated Primary Completion Date :||March 2017|
|Estimated Study Completion Date :||May 2017|
Active Comparator: 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.
Procedure: Trial removal of catheter in patients with urinary retention
The investigators are comparing two groups of patients (Group B) Trial removal of urinary catheter in patients with urinary retention without using catheter valve - 'Traditional method'
Experimental: 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
Procedure: Use of catheter valve before 'trial removal of catheter'
The investigators are comparing two groups of patients (Group A) Trial removal of urinary catheter in patients with urinary retention after applying catheter valve and closing it 3-4 hours before catheter removal.
- Time to spontaneous void after catheter removal [ Time Frame: 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.
- Complications associated with valve [ Time Frame: On the day of catheter removal ]To see if the patients with the catheter valve have more complications (catheter bypass, urinary tract infection and pain).
- Reduction in clinic waiting time (hours) [ Time Frame: On the day of catheter removal ]To see if usage of catheter valve results in early discharge after catheter removal resulting in reduction of time spent in the clinic (in hours)
- Reduction in the cost of running the clinic [ Time Frame: On the day of catheter removal ]To see if reduction in the time spent by the catheter valve patients results in reducing the cost of running of the TWOC (Trial without catheter) clinic (in British Pound Sterling).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02717975
|Contact: Shikohe Masood, MD||00441634830000 ext firstname.lastname@example.org|
|Contact: Robert Hughes, MA||00441634830000 ext email@example.com|
|Principal Investigator:||Shikohe Masood, MD||Medway NHS Foundation Trust|