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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Shikohe Masood, Medway NHS Foundation Trust

Brief 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 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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)

  3. 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).



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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Shikohe Masood, MD 00441634830000 ext 3781 shikohemasood@nhs.net
Contact: Robert Hughes, MA 00441634830000 ext 3129 robert.hughes@medway.nhs.uk

Locations
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United Kingdom
Medway NHS Foundation Trust Recruiting
Gillingham, Kent, United Kingdom, ME7 5NY
Contact: Shikohe Masood, MD    00441634830000 ext 3871    shikohemasood@nhs.net   
Contact: Robert Hughes, MA    00441634830000 ext 3129    robert.hughes@medway.nhs.uk   
Sponsors and Collaborators
Medway NHS Foundation Trust
Investigators
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Principal Investigator: Shikohe Masood, MD Medway NHS Foundation Trust
Publications:
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Responsible Party: Shikohe Masood, Consultant Urological Surgeon, Medway NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02717975    
Other Study ID Numbers: 191435
First Posted: March 24, 2016    Key Record Dates
Last Update Posted: March 28, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Shikohe Masood, Medway NHS Foundation Trust:
Urinary retention
trial removal of catheter
valve
Additional relevant MeSH terms:
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Urinary Retention
Urination Disorders
Urologic Diseases