Clinical trial NCT05480254: The Effect of Clamping Method the Indwelling Urinary Catheters
Official title: The Effect on Catheter-Related Complıcatıons of Clamping Method the Indwelling Urinary Catheters in ICU Patıents: A Randomızed Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bladder Training by Clamping Before Removal
Keywords: Clamping
Indwelling Urinary Catheters
Nursing
Lead sponsor: Cumhuriyet University
Sponsor class: OTHER
Collaborators: name: Cumhuriyet University
First posted: 2022-07-29
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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,

Primary outcomes:
measure: Enfectious complications
timeFrame: 1-5 days
Secondary outcomes:
measure: Other complications
timeFrame: 6. days 1-12 hour between
Other outcomes:
Locations:
city: Sivas
country: Turkey
facility: Cumhuriyet Universty
Study officials:
References: