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OpenTrials
Completed

NCT Number: NCT07053501

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Elazığ State Hospital

Erzurum, 25000, Turkey (Türkiye)

About this study

This randomized controlled trial was conducted between July and December 2023 in the Emergency and Urology departments of X State Hospital. The aim was to investigate the effects of an innovative urinary catheter carrying bag (UCCB) on patients' psychosocial outcomes, including satisfaction, body image, self-esteem, and feelings of shame.

Participants (n=70) were adults aged 18 and older who had been using an indwelling urinary catheter for at least three weeks. Following ethical approval and informed consent, they were randomly assigned to intervention or control groups. The intervention group received a urinary catheter carrying bag along with detailed training, while the control group continued with standard care.

Data collection tools included the Patient Satisfaction-VAS, Body Image Scale, Rosenberg Self-Esteem Scale, and The Other as Shamer Scale. Assessments were conducted before the intervention and after the 21-day follow-up period.

Statistical analyses revealed that patients using the UCCB showed significantly greater improvements in all primary outcomes compared to the control group. Regression models confirmed that the carrying bag had a significant positive effect on patient satisfaction and self-esteem, and a significant negative effect on body image disturbance and shame.

This study provides empirical evidence that a simple, low-cost supportive device can positively influence the psychological well-being of catheter users. The findings suggest that integrating such tools into standard nursing protocols may improve holistic patient care.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • Inclusion Criteria:
  • 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
  • Exclusion Criteria:
  • 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

Treatment and study plan

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.

Primary outcomes

  1. Change in Patient Satisfaction Score

    Time frame: Baseline and Day 21

    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.

Sponsors and collaborators

Lead sponsor

Bahar Ciftci

Other

Registry information

Official study title

The Effect of a Urinary Catheter Carrying Bag on Patients' Satisfaction, Body Image, Self-Esteem, and Shame: A Randomized Controlled Trial

Acronym: UCCB

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 8, 2025
Registry last updated
Jul 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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