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Efficacy of Reduction of the Balloon Volume for Prevention of Postoperative Catheter-related Bladder Discomfort in Patients Undergoing Non-lower Urinary Tract Surgery

Efficacy of Reduction of the Balloon Volume for Prevention of Postoperative Catheter-related Bladder Discomfort in Patients Undergoing Non-lower Urinary Tract Surgery

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06038448
Enrollment
120
Registered
2023-09-14
Start date
2023-09-18
Completion date
2023-12-31
Last updated
2023-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Catheter-Related Bladder Discomfort, Urinary Catheter

Keywords

urinary catheter, Catheter-Related Bladder Discomfort, balloon, nursing

Brief 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. 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

Interventions

PROCEDUREUrinary catheter balloon size

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.

Sponsors

Buddhist Tzu Chi General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Intervention model description

parallel into two groups, each urinary catheter balloon size 10mL and 5mL

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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. * 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.

Design outcomes

Primary

MeasureTime frameDescription
Degree of Catheter-related Bladder DiscomfortReturn to the ward after surgery 0 hours.3 hours.12 hoursLikert 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.

Secondary

MeasureTime frameDescription
Visual analog scale for pain severityReturn to the ward after surgery 0 hours.3 hours.12 hours0 to 10,the minimum value is 0 and the maximum value is 10. The larger the number, the more serious the discomfort is.

Contacts

Primary ContactOu Shiuan-Ru, Head Nurse
qp761009@gmail.com+886 38561825

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026