Effect of a Urinary Catheter Carrying Bag on Satisfaction, Body Image, Self-Esteem, and Shame

NCT07053501 | Completed

• 1 other identifier: B.30.2.ATA.0.01.00/513
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to evaluate the impact of using an innovative urinary catheter carrying bag on the psychosocial well-being of patients who require long-term catheterization. The bag was designed to increase comfort, hygiene, and privacy by concealing the urine bag and minimizing potential embarrassment during daily activities. A total of 70 patients who had been using an indwelling urinary catheter for at least three weeks were randomly assigned to either an intervention or a control group. The intervention group received a specially designed catheter carrying bag along with training on how to use it, while the control group received standard care without the carrying bag. All participants were monitored over a 21-day period. Validated assessment tools were used to measure patient satisfaction, body image, self-esteem, and feelings of external shame at baseline and after the intervention period. The study was designed to explore whether the use of the catheter carrying bag could influence these psychosocial outcomes in individuals undergoing long-term catheterization. This randomized controlled trial was conducted to inform future supportive care practices and explore non-pharmacological interventions that address both the physical and psychosocial needs of patients with indwelling urinary catheters.

Conditions

Long-Term Urinary Catheterization; Patient Satisfaction; Psychosocial Impact of Catheter Use; Low Self-Esteem; Body Image Disturbance

Keywords

Patient Satisfaction; Nursing Intervention; Self-Esteem Shame; Body Image; Catheter Carrying Bag; Urinary Catheter

Outcome Measures

Primary Outcomes (1)

• Change in Patient Satisfaction Score

  Patient satisfaction was assessed using a visual analog scale (VAS) at baseline (prior to intervention) and on Day 21 (post-intervention). The aim was to evaluate the impact of the catheter carrying bag on satisfaction related to urinary catheter use.

  Baseline and Day 21

Study Arms (2)

Intervention

EXPERIMENTAL

Patients used a specially designed urinary catheter carrying bag for 21 days along with training.

Device: Urinary Catheter Carrying Bag Use

Control

NO INTERVENTION

Patients received routine catheter care without any intervention.

Interventions

Urinary Catheter Carrying Bag Use DEVICE

A wearable catheter carrying bag was provided to participants. It was designed to conceal the urine bag and increase comfort, privacy, and psychosocial well-being. Participants received training on its use and wore it during all daily activities for 21 days.

Intervention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals aged 18 years or older
• Patients with an indwelling urinary catheter in place for at least 3 weeks
• Ability to communicate and provide informed consent
• Willingness to participate and comply with study procedures

You may not qualify if:

• Patients with cognitive impairment or communication difficulties
• Presence of active urinary tract infection at the time of enrollment
• Severe physical or psychiatric condition interfering with participation
• Previous participation in a similar catheter-related intervention study

Sponsors & Collaborators

• Bahar Ciftci: lead

Study Sites (1)

Elazığ State Hospital

Erzurum, Erzurum, 25000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, Department of Fundamental of Nursing, Atatürk University

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: July 8, 2025
• Study Start: July 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: July 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)