The Effect of Clamping Method the Indwelling Urinary Catheters

July 27, 2022 updated by: Hulya Kocyigit

The Effect on Catheter-Related Complıcatıons of Clamping Method the Indwelling Urinary Catheters in ICU Patıents: A Randomızed Controlled Trial

Background: Bladder training through catheter clamping is an important nursing practice. There is no clear information and sufficient evidence for catheter clamping in bladder training before urinary catheter removal in guidelines for clinical practice.

Objective: To evaluate the results of bladder training in ICU patients. Design: Randomized controlled trial. Setting general surgery ıntensıve care. Methods: Patients were randomly assigned either to have their urinary catheter clamped before removal or to have their catheter removed with free drainage.. Patients who will continue to have urinary catheterization for at least 5 days were included in the study.

Results: - Conclusion: -

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Nurses are key professionals in the prevention of complications associated with indwelling urinary catheterization in the hospital setting. In this context, bladder training through catheter clamping is an important nursing practice. Indwelling catheter clamping in bladder training was first proposed by Ross in 1936. There is no clear information and sufficient evidence for catheter clamping in bladder training before urinary catheter removal in national and international guidelines for clinical practice.

In a study by Williamson (1982) on this subject, it was reported that intermittent clamping before removal of the indwelling urinary catheter reduces the frequency of urinary retention and shortens the time to return to normal bladder function. However, a systematic review published in Cochrane (2007) on strategies for removal of short-term indwelling urethral catheters in adults found insufficient evidence to suggest that catheter clamping prior to termination of catheterization is effective to induce normal bladder filling. In another systematic review published in Cochrane (2016), there was no significant difference between the patients' subjective perceptions of recatheterization, urinary retention, catheter-related urinary tract infection and urination symptoms in the clamping and free drainage groups.

In the limited number of studies on bladder training performed by clamping the indwelling urinary catheter, no evidence for practice could be obtained, and there is no consensus among clinicians yet. Ultimately, more research, better quality methodology, and more diverse study designs are needed until strong evidence is available to remove this uncertainty.

Study Type

Interventional

Enrollment (Anticipated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
      • Sivas, Turkey, 58000
        • Recruiting
        • Cumhuriyet Universty

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Glasgow Coma Scale between 13-15 when clamping will be performed.
  • Within the first 12 hours of admission to the intensive care unit,
  • Will continue urinary catheterization for at least 5 days,
  • No diagnosed or recurrent urinary tract infection,
  • Patients who agreed to participate in the study by obtaining their informed consent and who will not leave the study during the study.

Exclusion Criteria:

  • Having urinary outflow resistance/difficulty (prostate enlargement, urethral stenosis, etc.),
  • Those who have suprapubic catheters or who will undergo intermittent catheterization,
  • Patients with impaired nerve conduction,
  • Patients taking anticholinergic drug therapy such as tricyclic antidepressants,
  • Patients receiving sympathomimetric drug therapy,
  • Having a neurogenic bladder,
  • Having diabetic cystopathy, Have a previous history of urinary retention or urination dysfunction,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: clamped catheter group
Q3 clamped catheter protocol is applied before urinary catheter removal
Other: clamped catheter
Q3 clamped catheter protocol is applied before urinary catheter removal
No Intervention: free dranaige group
Free dranaige is applied before urinary catheter removal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Enfectious complications
Time Frame: 1-5 days
Catheter-Related Infectious Complications Follow-up Form
1-5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Other complications
Time Frame: 6. days 1-12 hour between
Catheter-Related Non-Infectious Complications Follow-up Form
6. days 1-12 hour between

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hulya Kocyigit

Collaborators

Cumhuriyet University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2021

Primary Completion (Actual)

July 25, 2022

Study Completion (Anticipated)

October 30, 2022

Study Registration Dates

First Submitted

July 25, 2022

First Submitted That Met QC Criteria

July 27, 2022

First Posted (Actual)

July 29, 2022

Study Record Updates

Last Update Posted (Actual)

July 29, 2022

Last Update Submitted That Met QC Criteria

July 27, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Cumhuriyet Universty

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

I will share in 6 months

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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