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

Urinary Catheter Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06038448
• Other study ID #: TCRD112-017
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 18, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2023
• Source: Buddhist Tzu Chi General Hospital
• Contact: Ou Shiuan-Ru, Head Nurse
• Phone: +886 38561825
• Email: qp761009[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Catheter-Related Bladder Discomfort
• Urinary Catheter

Intervention

Procedure:
• Urinary 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Buddhist Tzu Chi General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Return to the ward after surgery 0 hours.3 hours.12 hours
Secondary	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.	Return to the ward after surgery 0 hours.3 hours.12 hours