Safety of automatic urine catheter valve in patients with urinary catheter

The safety of automatic urine catheter valve in patients with urinary catheter: A Randomized clinical Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20240510061725N1

Enrollment

Registered

2024-10-05

Start date

2024-09-22

Completion date

Unknown

Last updated

2025-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary retention. Retention of urine, unspecified

Interventions

Intervention 1: Intervention group: Urinary catheter connected to the automatic valve. In this group, the valve will be connected to the end of the Foley catheter and the necessary training regarding

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: patients with a disability to urinate voluntarily Willing to participate in the study

Exclusion criteria

Exclusion criteria: Mental disorders Severe neurological diseases, e.g. Dementia urinary tract infection

Design outcomes

Primary

Measure	Time frame
Determining safety of automatic urine catheter valve. Timepoint: Before starting the study, urine culture is done for all patients. If the culture is positive, a 7-day course of antibiotics is given. The start of the study protocol is started only after a negative urine culture is repeated. The outcome evaluation is done before the beginning of the study and at the end of the study (at the end of the third week (21 days) from the beginning of the survey). Method of measurement: using urine culture.;Patients' satisfaction. Timepoint: before the beginning of the study and at the end of the study (at the end of the third week (21 days) from the beginning of the survey). Method of measurement: Checklist of satisfaction with the received intervention: Satisfaction with the received intervention will be measured through an item that will be scored from 1 to 5 based on the Likert scale of completely satisfied, somewhat satisfied, neither satisfied nor dissatisfied, somewhat dissatisfied, and completely dissatisfied, and at the end of the intervention It will be completed through questions from participants.	—

Measure

Time frame

Determining safety of automatic urine catheter valve. Timepoint: Before starting the study, urine culture is done for all patients. If the culture is positive, a 7-day course of antibiotics is given. The start of the study protocol is started only after a negative urine culture is repeated. The outcome evaluation is done before the beginning of the study and at the end of the study (at the end of the third week (21 days) from the beginning of the survey). Method of measurement: using urine culture.;Patients' satisfaction. Timepoint: before the beginning of the study and at the end of the study (at the end of the third week (21 days) from the beginning of the survey). Method of measurement: Checklist of satisfaction with the received intervention: Satisfaction with the received intervention will be measured through an item that will be scored from 1 to 5 based on the Likert scale of completely satisfied, somewhat satisfied, neither satisfied nor dissatisfied, somewhat dissatisfied, and completely dissatisfied, and at the end of the intervention It will be completed through questions from participants.

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Secondary

Measure	Time frame
Determining the side effects (hematuria and urinary tract traumatization) caused by catheterization. Timepoint: Immediately after catheterization. Method of measurement: The amount of side effects caused by catheterization will be done using direct evaluation of the urinary tract. In this way, the researcher will record any complications caused by catheterization based on the side event evaluation checklist.	—

Measure

Time frame

Determining the side effects (hematuria and urinary tract traumatization) caused by catheterization. Timepoint: Immediately after catheterization. Method of measurement: The amount of side effects caused by catheterization will be done using direct evaluation of the urinary tract. In this way, the researcher will record any complications caused by catheterization based on the side event evaluation checklist.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactSakineh Hajebrahimi

Tabriz University of Medical Sciences

ebrahimis@tbzmed.ac.ir+98 41 3334 2219

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026