The Effect of Clamping Method the Indwelling Urinary Catheters

NCT ID: NCT05480254

Last Updated: 2022-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-15

Study Completion Date

2022-10-30

Brief Summary

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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: -

Detailed Description

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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.

Conditions

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Bladder Training by Clamping Before Removal

Keywords

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Clamping Indwelling Urinary Catheters Nursing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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clamped catheter group

Q3 clamped catheter protocol is applied before urinary catheter removal

Group Type EXPERIMENTAL

clamped catheter

Intervention Type OTHER

Q3 clamped catheter protocol is applied before urinary catheter removal

free dranaige group

Free dranaige is applied before urinary catheter removal

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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clamped catheter

Q3 clamped catheter protocol is applied before urinary catheter removal

Intervention Type OTHER

Eligibility Criteria

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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,
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Cumhuriyet University

OTHER

Sponsor Role collaborator

Hulya Kocyigit

OTHER

Sponsor Role lead

Responsible Party

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Hulya Kocyigit

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Cumhuriyet Universty

Sivas, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Hülya Kocyigit, Phd

Role: CONTACT

Phone: 905550408876

Email: [email protected]

Serife KARAGOZOGLU, Prof.Dr

Role: CONTACT

Phone: 903464870000

Email: [email protected]

Other Identifiers

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Cumhuriyet Universty

Identifier Type: -

Identifier Source: org_study_id