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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-18

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Early Patient Removal of Urinary Catheters After Urogynecologic Surgery

NCT06344884

Urinary Retention Postoperative Postoperative Urinary Tract Infection Catheter Site Pain

COMPLETED NA

The Effect of Early Postoperative Pain on Postoperative Delirium (POD) in Elderly Patients Undergoing Abdominal Surgery

NCT06964893

Postoperative Delirium (POD)

COMPLETED

Predictive Value of β2-microspheres for Postoperative Delirium

NCT03130231

Postoperative Delirium

COMPLETED

Effect of Bilateral RSB on Postoperative Delirium in Elderly Patients Undergoing Laparoendoscopic Single-site Surgery

NCT05280860

Delirium in Old Age Hernia, Inguinal Cholecystolithiasis

UNKNOWN NA

Postoperative Delirium in Patients Undergoing Radical Cystectomy

NCT03132168

Post-operative Delirium

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Catheter-Related Bladder Discomfort Urinary Catheter

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type ACTIVE_COMPARATOR

Urinary catheter balloon size

Intervention Type PROCEDURE

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 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

Group Type ACTIVE_COMPARATOR

Urinary catheter balloon size

Intervention Type PROCEDURE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No