NCT06038448

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 14, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

September 18, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

September 21, 2023

Status Verified

May 1, 2023

Enrollment Period

3 months

First QC Date

September 8, 2023

Last Update Submit

September 18, 2023

Conditions

Catheter-Related Bladder DiscomfortUrinary Catheter

Keywords

urinary catheterCatheter-Related Bladder Discomfortballoonnursing

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Visual analog scale for pain severity

    Return to the ward after surgery 0 hours.3 hours.12 hours

Study Arms (2)

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

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

Procedure: Urinary catheter balloon size

Interventions

Urinary catheter balloon sizePROCEDURE

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.

Effect of normal 10ml balloon volume on postoperative CRBD in non-LUTS patientsEffect of reduction of 5ml balloon volume for postoperative CRBD in patients undergoing non-LUTS

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age from 20-80 year-old
  • in urological surgery under the general anesthesia
  • arms: (1)non-lower urinary tract surgery: hernia, and nephrectomy surgery , (2) lower urinary tract surgery: stone surgery after ureter catheter insertion.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Ou Shiuan-Ru, Head Nurse

CONTACT

+886 38561825qp761009@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: parallel into two groups, each urinary catheter balloon size 10mL and 5mL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2023

First Posted

September 14, 2023

Study Start

September 18, 2023

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

September 21, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share