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Clinical Trials/NCT06038448
NCT06038448UnknownNot Applicable

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

Buddhist Tzu Chi General Hospital0 sites120 target enrollmentStarted: September 18, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
120
Primary Endpoint
Degree of Catheter-related Bladder Discomfort

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Participant)

Eligibility Criteria

Ages
20 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts 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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Visual analog scale for pain severity(Return to the ward after surgery 0 hours.3 hours.12 hours)

Investigators

Sponsor
Buddhist Tzu Chi General Hospital
Sponsor Class
Other
Responsible Party
Sponsor

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