Bladder Training by Clamping Before RemovalNCT05480254
The Effect of Clamping Method the Indwelling Urinary Catheters
A study testing clamped catheter in people with Bladder Training by Clamping Before Removal, run by Hulya Kocyigit at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bladder Training by Clamping Before Removal
- What is being tested?
- clamped catheter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2021to 30 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Cumhuriyet Universty
Sivas, 58000
About this study
Official title: 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: -
Read the 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.
- Being tested
- clamped catheter
- Keywords
- Clamping, Indwelling Urinary Catheters, Nursing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clamped catheterOther
Q3 clamped catheter protocol is applied before urinary catheter removal
| Study group | Role | What they receive |
|---|---|---|
| clamped catheter group | Experimental | Q3 clamped catheter protocol is applied before urinary catheter removal Receives: Other: clamped catheter |
| free dranaige group | No intervention | Free dranaige is applied before urinary catheter removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enfectious complications
Catheter-Related Infectious Complications Follow-up Form
Measured: 1-5 days
Secondary outcomes (1)
Other complications
Catheter-Related Non-Infectious Complications Follow-up Form
Measured: 6. days 1-12 hour between
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start15 Apr 2021
- Primary completion25 Jul 2022
- Study completion30 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder Training by Clamping Before RemovalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hulya Kocyigit
- Sponsor type
- University, hospital or other
- Collaborators
- Cumhuriyet University
- Responsible party
- Sponsor-investigator, Hulya Kocyigit, Cumhuriyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05480254
- Sponsor's protocol ID
- Cumhuriyet Universty
- Status last verified
- Jul 2022
- First submitted
- 25 Jul 2022
- Last updated
- 29 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I will share in 6 months
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect on Catheter-Related Complıcatıons of Clamping Method the Indwelling Urinary Catheters in ICU Patıents: A Randomızed Controlled Trial
- ClinicalTrials.gov ID
- NCT05480254
- Acronym / sponsor ID
- Cumhuriyet Universty
- Keywords
- Clamping, Indwelling Urinary Catheters, Nursing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Hulya KocyigitUniversity, hospital or other
- Collaborators
- Cumhuriyet University
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 25 Jul 2022 (actual)
- Study completion
- 30 Oct 2022 (estimated)
- First posted
- 29 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| clamped catheter group | Experimental | Other: clamped catheterQ3 clamped catheter protocol is applied before urinary catheter removal |
| free dranaige group | No intervention | –Free dranaige is applied before urinary catheter removal |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clamped catheterQ3 clamped catheter protocol is applied before urinary catheter removal | Other | clamped catheter group |
Primary outcome
Enfectious complications
Time frame: 1-5 days
Catheter-Related Infectious Complications Follow-up Form
1 secondary outcome
Other complications
Time frame: 6. days 1-12 hour between
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2022.
- Individual participant dataSharing planned: No. I will share in 6 months
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing clamped catheter in people with Bladder Training by Clamping Before Removal, run by Hulya Kocyigit at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hülya Kocyigit, Phd (905550408876 ext. 2940, kcygthulya@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enfectious complications (time frame: 1-5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2022.