Clinical Study on Disposable Sterile Urinary Catheter

NCT ID: NCT05651217

Last Updated: 2023-02-21

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

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-11

Study Completion Date

2023-02-10

Brief Summary

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This study is a multicenter, randomized controlled study, with the urinary tract infection rate at the time of catheter insertion for 1 week as the primary end point. By comparing the clinical safety and effectiveness of two kinds of urethral catheters, to evaluate the clinical application effect of one kind of urethral catheters.

Detailed Description

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Conditions

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Urinary Catheters Urinary Tract Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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trial group

Patients in this group used the disposable urinary catheter

Group Type EXPERIMENTAL

disposable urinary catheter

Intervention Type DEVICE

The trial group was intervened with disposable sterile urinary catheter. The model of the trial group includes two chamber type (Fr8, Fr10, Fr12, Fr14, Fr16, Fr18, Fr20, Fr22, Fr24) and three chamber type (Fr16, Fr18, Fr20, Fr22, Fr24).

control group

Patients in this group used super smooth antibacterial urinary catheter

Group Type ACTIVE_COMPARATOR

super smooth antibacterial urinary catheter

Intervention Type DEVICE

the control group was intervened with ultra smooth antibacterial catheter. The control group models include single chamber (6Fr, 8Fr, 10Fr, 12Fr, 14Fr, 16Fr, 18Fr, 20Fr, 22Fr, 24Fr), double chamber (6Fr, 8Fr, 10Fr, 12Fr, 14Fr, 16Fr, 18Fr, 20Fr, 22Fr, 24Fr, 26Fr, 28Fr, 30Fr), and three chamber (16Fr, 18Fr, 20Fr, 22Fr, 24Fr, 26Fr)

Interventions

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disposable urinary catheter

The trial group was intervened with disposable sterile urinary catheter. The model of the trial group includes two chamber type (Fr8, Fr10, Fr12, Fr14, Fr16, Fr18, Fr20, Fr22, Fr24) and three chamber type (Fr16, Fr18, Fr20, Fr22, Fr24).

Intervention Type DEVICE

super smooth antibacterial urinary catheter

the control group was intervened with ultra smooth antibacterial catheter. The control group models include single chamber (6Fr, 8Fr, 10Fr, 12Fr, 14Fr, 16Fr, 18Fr, 20Fr, 22Fr, 24Fr), double chamber (6Fr, 8Fr, 10Fr, 12Fr, 14Fr, 16Fr, 18Fr, 20Fr, 22Fr, 24Fr, 26Fr, 28Fr, 30Fr), and three chamber (16Fr, 18Fr, 20Fr, 22Fr, 24Fr, 26Fr)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 18-80 year old patients;
* Retained catheter ≥ 7 days;
* Patients who were conscious and had good communication skills and volunteered to participate in the study.

Exclusion Criteria

* Pregnant and lactating female patients;
* Diabetes patients;
* Patients allergic to sulfadiazine, silica gel and stainless steel;
* Urethral malformation, acute urethral injury, prostate disease, intermittent catheterization, suprapubic cystostomy and other patients who are not suitable for catheterization;
* Patients who have used urinary catheters for a long time or had catheters retained within one week;
* Patients who are participating in other clinical trials that interfere with this trial.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shandong Branden Med.Device Co.,Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Liaoning Cancer Hospital & institute

Dalian, Liaoning, China

Site Status

Countries

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China

Other Identifiers

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B201703

Identifier Type: -

Identifier Source: org_study_id

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