Catheter-Related Bladder DiscomfortNCT06038448
Efficacy of Reduction of the Balloon Volume for Prevention of Postoperative Catheter-related Bladder Discomfort in Patients Undergoing Non-lower Urinary Tract Surgery
A study testing Urinary catheter balloon size in people with Catheter-Related Bladder Discomfort and Urinary Catheter, run by Buddhist Tzu Chi General Hospital.
Trial summary
CRBD is related to different degrees of irritation caused by the volume of the balloon in the urinary catheter, and when CRBD occurs, it may cause severe postoperative pain and trauma by self-removal of the catheter, further leading complications. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Catheter-Related Bladder Discomfort, Urinary Catheter
- What is being tested?
- Urinary catheter balloon size
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 18 Sep 2023to 31 Dec 2023
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age from 20-80 year-old
- in urological surgery under the general anesthesia
- 2 arms: (1)non-lower urinary tract surgery: hernia, and nephrectomy surgery , (2) lower urinary tract surgery: stone surgery after ureter catheter insertion.
Who cannot join
- Patients not undergoing hernia repair or nephrectomy.
- Patients who are not undergoing ureteral lithotripsy and renal stone extraction.
- Those who are already using drugs for overactive bladder or prostatic hypertrophy.
- Retrograde intrarenal surgery (RIRS) for stone extraction.
- People with dementia.
- Patients with cognitive impairment.
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- Patients with impaired consciousness.
- Patients who are unable to communicate verbally.
- The subject had participated in other experimental drug trials one month before the study entered.
Trial locations and contacts
No sites are listed yet.
About this study
CRBD is related to different degrees of irritation caused by the volume of the balloon in the urinary catheter, and when CRBD occurs, it may cause severe postoperative pain and trauma by self-removal of the catheter, further leading complications. Although many drugs can improve CRBD, measures that can be immediately intervened by non-nursing staff at any time and even have different side effects on patients due to drug use.Therefore, the author wants to use this study to explore the reduction of catheter balloon volume can effectively reduce the degree of CRBD, is a non-invasive and immediately executable nursing treatment.the quality of clinical care and hospitalization of the patient can be further improved, reducing the patient's inappropriate, thereby improving the quality of medical care.
Read the detailed description
Catheter-Related Bladder Discomfort (CRBD) has been attached importance in recent years. Reducing the discomfort of patients with effective treatment is a part of our medical and nursing care that needs to be paid more attention to. The literature has pointed out that CRBD is related to different degrees of irritation caused by the volume of the balloon in the urinary catheter, and when CRBD occurs, it may cause severe postoperative pain and trauma by self-removal of the catheter, further leading to urethral injury and subsequent urethral stricture, and complications such as bleeding, surgical wound dehiscence, and arrhythmia. Although many drugs can improve CRBD, measures that can be immediately intervened by non-nursing staff at any time and even have different side effects on patients due to drug use.
In the past 20 years, only one piece of literature has discussed the effect of catheter balloon volume on CRBD, and the sample size is relatively small and even not related to the Asian region. Therefore, the author wants to use this study to explore the reduction of catheter balloon volume can effectively reduce the degree of CRBD, the investigators will collect in different procedure(stone procedure, herniarraphy, nephrectomy), and the investigators used different urinary catheter balloon size(10ml and 5ml), tp investigate the patient with the severity of catheter-related bladder discomfort.In addition to reducing the side effects of patients due to drug use, is a non-invasive and immediately executable nursing treatment.
Further, if post-evidence nursing intervention can effectively reduce the CRBD generated, thereby increasing the patient's comfort, and allowing the patient to cooperate more with the treatment to achieve an effective therapeutic effect, thereby improving the quality of care and the enlargement of recovery.
Eventually, the quality of clinical care and hospitalization of the patient can be further improved, reducing the patient's inappropriate, thereby improving the quality of medical care.
Key words: Catheter-Related Bladder Discomfort, urinary catheter, balloon, nursing
- Being tested
- Urinary catheter balloon size
- Keywords
- urinary catheter, Catheter-Related Bladder Discomfort, balloon, nursing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urinary catheter balloon sizeProcedure or surgery
The investigators will collect 120 participants divided into two groups ,in different procedure(stone procedure, herniarraphy, nephrectomy), and the investigators used different urinary catheter balloon size(10ml and 5ml), tp investigate the patient with the severity of catheter-related bladder discomfort.
| Study group | Role | What they receive |
|---|---|---|
| Effect of normal 10ml balloon volume on postoperative CRBD in non-LUTS patients | Active comparator | Efficacy of normal 10ml balloon volume for prevention of postoperative catheter-related bladder discomfort in patients undergoing non-lower urinary tract surgery Receives: Procedure: Urinary catheter balloon size |
| Effect of reduction of 5ml balloon volume for postoperative CRBD in patients undergoing non-LUTS | Active comparator | Efficacy of reduction of 5ml the balloon volume for prevention of postoperative catheter-related bladder discomfort in patients undergoing non-lower urinary tract surgery Receives: Procedure: Urinary catheter balloon size |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of Catheter-related Bladder Discomfort
Likert scale 0.1.2.3,the minimum value is 0 and the maximum value is 3. The larger the number, the more serious the discomfort is.
Measured: Return to the ward after surgery 0 hours.3 hours.12 hours
Secondary outcomes (1)
Visual analog scale for pain severity
0 to 10,the minimum value is 0 and the maximum value is 10. The larger the number, the more serious the discomfort is.
Measured: Return to the ward after surgery 0 hours.3 hours.12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start18 Sep 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheter-Related Bladder DiscomfortStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- parallel into two groups, each urinary catheter balloon size 10mL and 5mL
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Buddhist Tzu Chi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06038448
- Sponsor's protocol ID
- TCRD112-017
- Status last verified
- May 2023
- First submitted
- 8 Sep 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Reduction of the Balloon Volume for Prevention of Postoperative Catheter-related Bladder Discomfort in Patients Undergoing Non-lower Urinary Tract Surgery
- ClinicalTrials.gov ID
- NCT06038448
- Acronym / sponsor ID
- TCRD112-017
- Keywords
- urinary catheter, Catheter-Related Bladder Discomfort, balloon, nursing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Buddhist Tzu Chi General HospitalUniversity, hospital or other
- Study start
- 18 Sep 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 14 Sep 2023 (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.
CRBD is related to different degrees of irritation caused by the volume of the balloon in the urinary catheter, and when CRBD occurs, it may cause severe postoperative pain and trauma by self-removal of the catheter, further leading complications. Although many drugs can improve CRBD, measures that can be immediately intervened by non-nursing staff at any time and even have different side effects on patients due to drug use.Therefore, the author wants to use this study to explore the reduction of catheter balloon volume can effectively reduce the degree of CRBD, is a non-invasive and immediately executable nursing treatment.the quality of clinical care and hospitalization of the patient can be further improved, reducing the patient's inappropriate, thereby improving the quality of medical care.
Detailed description
Catheter-Related Bladder Discomfort (CRBD) has been attached importance in recent years. Reducing the discomfort of patients with effective treatment is a part of our medical and nursing care that needs to be paid more attention to. The literature has pointed out that CRBD is related to different degrees of irritation caused by the volume of the balloon in the urinary catheter, and when CRBD occurs, it may cause severe postoperative pain and trauma by self-removal of the catheter, further leading to urethral injury and subsequent urethral stricture, and complications such as bleeding, surgical wound dehiscence, and arrhythmia. Although many drugs can improve CRBD, measures that can be immediately intervened by non-nursing staff at any time and even have different side effects on patients due to drug use.
In the past 20 years, only one piece of literature has discussed the effect of catheter balloon volume on CRBD, and the sample size is relatively small and even not related to the Asian region. Therefore, the author wants to use this study to explore the reduction of catheter balloon volume can effectively reduce the degree of CRBD, the investigators will collect in different procedure(stone procedure, herniarraphy, nephrectomy), and the investigators used different urinary catheter balloon size(10ml and 5ml), tp investigate the patient with the severity of catheter-related bladder discomfort.In addition to reducing the side effects of patients due to drug use, is a non-invasive and immediately executable nursing treatment.
Further, if post-evidence nursing intervention can effectively reduce the CRBD generated, thereby increasing the patient's comfort, and allowing the patient to cooperate more with the treatment to achieve an effective therapeutic effect, thereby improving the quality of care and the enlargement of recovery.
Eventually, the quality of clinical care and hospitalization of the patient can be further improved, reducing the patient's inappropriate, thereby improving the quality of medical care.
Key words: Catheter-Related Bladder Discomfort, urinary catheter, balloon, nursing
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- parallel into two groups, each urinary catheter balloon size 10mL and 5mL
| Arm | Type | Receives |
|---|---|---|
| Effect of normal 10ml balloon volume on postoperative CRBD in non-LUTS patients | Active comparator | Procedure: Urinary catheter balloon sizeEfficacy of normal 10ml balloon volume for prevention of postoperative catheter-related bladder discomfort in patients undergoing non-lower urinary tract surgery |
| Effect of reduction of 5ml balloon volume for postoperative CRBD in patients undergoing non-LUTS | Active comparator | Procedure: Urinary catheter balloon sizeEfficacy of reduction of 5ml the balloon volume for prevention of postoperative catheter-related bladder discomfort in patients undergoing non-lower urinary tract surgery |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age from 20-80 year-old
- in urological surgery under the general anesthesia
- 2 arms: (1)non-lower urinary tract surgery: hernia, and nephrectomy surgery , (2) lower urinary tract surgery: stone surgery after ureter catheter insertion.
Key exclusion criteria (9 listed)
- Patients not undergoing hernia repair or nephrectomy.
- Patients who are not undergoing ureteral lithotripsy and renal stone extraction.
- Those who are already using drugs for overactive bladder or prostatic hypertrophy.
- Retrograde intrarenal surgery (RIRS) for stone extraction.
- People with dementia.
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 |
|---|---|---|
| Urinary catheter balloon sizeThe investigators will collect 120 participants divided into two groups ,in different procedure(stone procedure, herniarraphy, nephrectomy), and the investigators used different urinary catheter balloon size(10ml and 5ml), tp investigate the patient with the severity of catheter-related bladder discomfort. | Procedure or surgery | Effect of normal 10ml balloon volume on postoperative CRBD in non-LUTS patients, Effect of reduction of 5ml balloon volume for postoperative CRBD in patients undergoing non-LUTS |
Primary outcome
Degree of Catheter-related Bladder Discomfort
Time frame: Return to the ward after surgery 0 hours.3 hours.12 hours
Likert scale 0.1.2.3,the minimum value is 0 and the maximum value is 3. The larger the number, the more serious the discomfort is.
1 secondary outcome
Visual analog scale for pain severity
Time frame: Return to the ward after surgery 0 hours.3 hours.12 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Urinary catheter balloon size in people with Catheter-Related Bladder Discomfort and Urinary Catheter, run by Buddhist Tzu Chi General Hospital.
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 3 inclusion and 9 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 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Ou Shiuan-Ru, Head Nurse (+886 38561825, qp761009@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of Catheter-related Bladder Discomfort (time frame: Return to the ward after surgery 0 hours.3 hours.12 hours). 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 21 Sep 2023.