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

NCT02717975 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2016-03-28

No results posted yet for this study

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.

Conditions

  • Urinary Retention

Interventions

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.

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'

Sponsors & Collaborators

  • Medway NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Shikohe Masood, MD · Medway NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
85 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2017-03-31
Completion
2017-05-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02717975 on ClinicalTrials.gov