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

Sponsor
Buddhist Tzu Chi General Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06038448
Collaborator
(none)
120
2
3.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Urinary catheter balloon size
N/A

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
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
parallel into two groups, each urinary catheter balloon size 10mL and 5mLparallel into two groups, each urinary catheter balloon size 10mL and 5mL
Masking:
Single (Participant)
Primary Purpose:
Prevention
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
Anticipated Study Start Date :
Sep 18, 2023
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Effect of normal 10ml balloon volume on postoperative CRBD in non-LUTS patients

Efficacy of normal 10ml balloon volume for prevention of postoperative catheter-related bladder discomfort in patients undergoing non-lower urinary tract surgery

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.

Active Comparator: Effect of reduction of 5ml balloon volume for postoperative CRBD in patients undergoing non-LUTS

Efficacy of reduction of 5ml the balloon volume for prevention of postoperative catheter-related bladder discomfort in patients undergoing non-lower urinary tract surgery

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.

Outcome Measures

Primary Outcome Measures

  1. Degree of Catheter-related Bladder Discomfort [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 Outcome Measures

  1. Visual analog scale for pain severity [Return to the ward after surgery 0 hours.3 hours.12 hours]

    0 to 10,the minimum value is 0 and the maximum value is 10. The larger the number, the more serious the discomfort is.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 80 Years
Sexes Eligible for Study:
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Buddhist Tzu Chi General Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Buddhist Tzu Chi General Hospital
ClinicalTrials.gov Identifier:
NCT06038448
Other Study ID Numbers:
  • TCRD112-017
First Posted:
Sep 14, 2023
Last Update Posted:
Sep 21, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Buddhist Tzu Chi General Hospital

Study Results

No Results Posted as of Sep 21, 2023