Long-Term Urinary CatheterizationUCCBNCT07053501
Effect of a Urinary Catheter Carrying Bag on Satisfaction, Body Image, Self-Esteem, and Shame
A study testing Urinary Catheter Carrying Bag Use in people with Long-Term Urinary Catheterization and Patient Satisfaction, run by Bahar Ciftci at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Long-Term Urinary Catheterization, Patient Satisfaction, Psychosocial Impact of Catheter Use
- What is being tested?
- Urinary Catheter Carrying Bag Use
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2023to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of a Urinary Catheter Carrying Bag on Patients' Satisfaction, Body Image, Self-Esteem, and Shame: A Randomized Controlled Trial
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Long-Term Urinary Catheterization, Patient Satisfaction, Psychosocial Impact of Catheter Use, Low Self-Esteem, Body Image Disturbance
- Being tested
- Urinary Catheter Carrying Bag Use
- Keywords
- Patient Satisfaction, Nursing Intervention, Self-Esteem Shame, Body Image, Catheter Carrying Bag, Urinary Catheter
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urinary Catheter Carrying Bag UseDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Patients used a specially designed urinary catheter carrying bag for 21 days along with training. Receives: Device: Urinary Catheter Carrying Bag Use |
| Control | No intervention | Patients received routine catheter care without any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start1 Jul 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long-Term Urinary CatheterizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bahar Ciftci
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bahar Ciftci, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07053501
- Sponsor's protocol ID
- B.30.2.ATA.0.01.00/513
- Acronym
- UCCB
- Status last verified
- Jun 2025
- First submitted
- 19 Jun 2025
- Last updated
- 8 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Urinary Catheter Carrying Bag on Patients' Satisfaction, Body Image, Self-Esteem, and Shame: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07053501
- Acronym / sponsor ID
- UCCB / B.30.2.ATA.0.01.00/513
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Bahar CiftciUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 8 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Urinary Catheter Carrying Bag UsePatients used a specially designed urinary catheter carrying bag for 21 days along with training. |
| Control | No intervention | –Patients received routine catheter care without any intervention. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urinary Catheter Carrying Bag UseA 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. | Device | Intervention |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urinary Catheter Carrying Bag Use in people with Long-Term Urinary Catheterization and Patient Satisfaction, run by Bahar Ciftci at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Patient Satisfaction Score (time frame: Baseline and Day 21). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.