The Effect of Clamping Method the Indwelling Urinary Catheters

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: Bladder Training by Clamping Before Removal
• Intervention / Treatment: Other: clamped catheter

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

• Study Contact: Name: Hülya Kocyigit, Phd; Phone Number: 2940 905550408876; Email: kcygthulya@outlook.com
• Study Contact Backup: Name: Serife KARAGOZOGLU, Prof.Dr; Phone Number: 1545 903464870000; Email: serifekaragozoglu@gmail.com

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	Catheter-Related Infectious Complications Follow-up Form	1-5 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hulya Kocyigit
• Collaborators: Cumhuriyet University

Study record dates

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: Nursing; Clamping; Indwelling Urinary Catheters
• 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