Urinary System DisorderNCT06571058
B3 Buddy for Securing Urinary Drainage Bag to Patient While Walking
A study testing Assistance, Educational Intervention and Medical Device Usage and Evaluation in people with Urinary System Disorder, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
This clinical trial tests how well the Bag Below Bladder (B3) Buddy device works in securing urinary drainage bags while walking. Keeping a urinary drainage bag below the bladder is the standard of care to maintain urine flow and prevent urine from backing up into the bladder. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Urinary System Disorder
- What is being tested?
- Assistance, Educational Intervention and Medical Device Usage and Evaluation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2023to 17 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- PATIENT PARTICIPANT: Must be English-speaking
- PATIENT PARTICIPANT: Able to comprehend and agree to consent
- PATIENT PARTICIPANT: Able to read and complete the Acceptability of Implementation Measure (AIM) survey
- PATIENT PARTICIPANT: Be willing to participate using the B3 Buddy device
- PATIENT PARTICIPANT: Have an indwelling urinary catheter or urostomy device connected to a drainage bag
- PATIENT PARTICIPANT: Have no restrictions in ambulation
Show all 11Show fewer
- CLINICIAN PARTICIPANT: Must be English-speaking
- CLINICIAN PARTICIPANT: Able to comprehend and agree to consent
- CLINICIAN PARTICIPANT: Able to read and complete the System Usability Scale (SUS) survey
- CLINICIAN PARTICIPANT: Be willing to participate using the B3 Buddy device
- CLINICIAN PARTICIPANT: Have a professional role in assisting patients in ambulation in normal workday activities
Who cannot join
- Those patient participants that have more than one urinary-like drainage bags will be excluded. This exclusion is due to the limited prototype samples available to the research team. Limiting one device for one patient with multiple drainage bags may not allow for accurate assessment of the B3 Buddy device
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: Feasibility Testing of a Urinary Drainage Bag Securement Device to Improve Patient and Clinician Ambulation Experiences
This clinical trial tests how well the Bag Below Bladder (B3) Buddy device works in securing urinary drainage bags while walking. Keeping a urinary drainage bag below the bladder is the standard of care to maintain urine flow and prevent urine from backing up into the bladder. Despite the use of modern urinary drainage bags for over 60 years, workarounds, including hooking the bag into pants pockets, are being used to secure the bags while walking. The B3 Buddy may help keep the urinary drainage bag at the proper level for drainage while walking.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate the acceptability of the B3 Buddy, from the patient's perspective.
II. To evaluate the usability of the B3 Buddy, from the clinician's perspective.
OUTLINE: Patients are assigned to 1 of 2 groups.
PATIENTS: Patients receive a short instructional session, wear the B3 Buddy device to secure urinary drainage bag and walk approximately 90 feet before urinary drainage bag is returned to the standard position on study.
CLINICIANS: Clinicians receive a short instructional session, secure the urinary drainage bag to the patient using the B3 Buddy device. Clinicians also assist patient with walking and then remove the device and return urinary drainage bag to the standard position on study.
- Conditions
- Urinary System Disorder
- Being tested
- Assistance, Educational Intervention, Medical Device Usage and Evaluation, Questionnaire Administration, Remove
- Medical subject headings
- Urologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AssistanceOther
Also called Aid, Assist, Help
Assist patient with walking approximately 90 feet
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Receive a short instructional session
Medical Device Usage and EvaluationDevice
Wear the B3 Buddy device
Medical Device Usage and EvaluationOther
Secure the urinary drainage bag to the patient using the B3 Buddy device
Questionnaire AdministrationOther
Ancillary studies
RemoveProcedure or surgery
Also called Removal
Remove the device and return urinary drainage bag to the standard position
WalkingOther
Also called Ambulation, By Foot, On Foot, Walk
Walk approximately 90 feet
| Study group | Role | What they receive |
|---|---|---|
| Clinicians (B3 Buddy) | Experimental | Clinicians receive a short instructional session, secure the urinary drainage bag to the patient using the B3 Buddy device. Clinicians also assist patient with walking and then remove the device and return urinary drainage bag to the standard position on study. Receives: Other: Assistance; Other: Educational Intervention; Other: Medical Device Usage and Evaluation; Other: Questionnaire Administration; Procedure: Remove |
| Patients (B3 Buddy) | Experimental | Patients receive a short instructional session, wear the B3 Buddy device to secure urinary drainage bag and walk approximately 90 feet before urinary drainage bag is returned to the standard position on study. Receives: Other: Educational Intervention; Device: Medical Device Usage and Evaluation; Other: Questionnaire Administration; Other: Walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of Device
The proportion of patients who find the device acceptable will be determined with the Acceptability of Implementation Measure tool. he AIM has 4 Likert items, ranging from 1 (for "completely disagree") to 5 (for "completely agree"). A higher number indicates greater acceptability. If a patient marked 3 or more items with at least a "4," the device was considered acceptable. The device will be considered acceptable if at least 70% of patient participants find the device acceptable, which will be calculated by survey responses.
Measured: Up to 17 minutes
Usability of Device
Clinicians perception of usability will be determined with the System Usability Scale. The System Usability Scale score ranges from 0 to 100, where 100 represents the highest possible perceived usability. The device will be considered usable if the overall mean score is 68 or greater, which will be calculated by survey responses.
Measured: Up to 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start27 Jul 2023
- Primary completion17 Nov 2023
- Study completion17 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Urinary System DisorderStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen Meade, Ohio State University Comprehensive Cancer Center
- Investigators
- Karen Meade, MS, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06571058
- Sponsor's protocol ID
- OSU-22357
- Other IDs
- NCI-2024-04927
- Status last verified
- Apr 2025
- First submitted
- 27 Jun 2024
- Last updated
- 30 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Testing of a Urinary Drainage Bag Securement Device to Improve Patient and Clinician Ambulation Experiences
- ClinicalTrials.gov ID
- NCT06571058
- Acronym / sponsor ID
- OSU-22357
- Conditions
- Urinary System Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 27 Jul 2023 (actual)
- Primary completion
- 17 Nov 2023 (actual)
- Study completion
- 17 Nov 2023 (actual)
- First posted
- 26 Aug 2024 (actual)
- Results
- Posted 30 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial tests how well the Bag Below Bladder (B3) Buddy device works in securing urinary drainage bags while walking. Keeping a urinary drainage bag below the bladder is the standard of care to maintain urine flow and prevent urine from backing up into the bladder. Despite the use of modern urinary drainage bags for over 60 years, workarounds, including hooking the bag into pants pockets, are being used to secure the bags while walking. The B3 Buddy may help keep the urinary drainage bag at the proper level for drainage while walking.
Detailed description
PRIMARY OBJECTIVES:
- To evaluate the acceptability of the B3 Buddy, from the patient's perspective.
II. To evaluate the usability of the B3 Buddy, from the clinician's perspective.
OUTLINE: Patients are assigned to 1 of 2 groups.
PATIENTS: Patients receive a short instructional session, wear the B3 Buddy device to secure urinary drainage bag and walk approximately 90 feet before urinary drainage bag is returned to the standard position on study.
CLINICIANS: Clinicians receive a short instructional session, secure the urinary drainage bag to the patient using the B3 Buddy device. Clinicians also assist patient with walking and then remove the device and return urinary drainage bag to the standard position on study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinicians (B3 Buddy) | Experimental | Other: Assistance, Other: Educational Intervention, Other: Medical Device Usage and Evaluation, Other: Questionnaire Administration, Procedure: RemoveClinicians receive a short instructional session, secure the urinary drainage bag to the patient using the B3 Buddy device. Clinicians also assist patient with walking and then remove the device and return urinary drainage bag to the standard position on study. |
| Patients (B3 Buddy) | Experimental | Other: Educational Intervention, Device: Medical Device Usage and Evaluation, Other: Questionnaire Administration, Other: WalkingPatients receive a short instructional session, wear the B3 Buddy device to secure urinary drainage bag and walk approximately 90 feet before urinary drainage bag is returned to the standard position on study. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- PATIENT PARTICIPANT: Must be English-speaking
- PATIENT PARTICIPANT: Able to comprehend and agree to consent
- PATIENT PARTICIPANT: Able to read and complete the Acceptability of Implementation Measure (AIM) survey
- PATIENT PARTICIPANT: Be willing to participate using the B3 Buddy device
- PATIENT PARTICIPANT: Have an indwelling urinary catheter or urostomy device connected to a drainage bag
Key exclusion criteria (1 listed)
- Those patient participants that have more than one urinary-like drainage bags will be excluded. This exclusion is due to the limited prototype samples available to the research team. Limiting one device for one patient with multiple drainage bags may not allow for accurate assessment of the B3 Buddy device
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 |
|---|---|---|
| AssistanceAlso: Aid, Assist, HelpAssist patient with walking approximately 90 feet | Other | Clinicians (B3 Buddy) |
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalReceive a short instructional session | Other | Clinicians (B3 Buddy), Patients (B3 Buddy) |
| Medical Device Usage and EvaluationWear the B3 Buddy device | Device | Patients (B3 Buddy) |
| Medical Device Usage and EvaluationSecure the urinary drainage bag to the patient using the B3 Buddy device | Other | Clinicians (B3 Buddy) |
| Questionnaire AdministrationAncillary studies | Other | Clinicians (B3 Buddy), Patients (B3 Buddy) |
| RemoveAlso: RemovalRemove the device and return urinary drainage bag to the standard position | Procedure or surgery | Clinicians (B3 Buddy) |
| WalkingAlso: Ambulation, By Foot, On Foot, WalkWalk approximately 90 feet | Other | Patients (B3 Buddy) |
Primary outcome
Acceptability of Device
Time frame: Up to 17 minutes
The proportion of patients who find the device acceptable will be determined with the Acceptability of Implementation Measure tool. he AIM has 4 Likert items, ranging from 1 (for "completely disagree") to 5 (for "completely agree"). A higher number indicates greater acceptability. If a patient marked 3 or more items with at least a "4," the device was considered acceptable. The device will be considered acceptable if at least 70% of patient participants find the device acceptable, which will be calculated by survey responses.
Usability of Device
Time frame: Up to 20 minutes
Clinicians perception of usability will be determined with the System Usability Scale. The System Usability Scale score ranges from 0 to 100, where 100 represents the highest possible perceived usability. The device will be considered usable if the overall mean score is 68 or greater, which will be calculated by survey responses.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- The JameslineLink provided by the sponsor.
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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.
Karen Meade, MS principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assistance, Educational Intervention and Medical Device Usage and Evaluation in people with Urinary System Disorder, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
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 11 inclusion and 1 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 30 Apr 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 United States. 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?
Yes. Results are posted in the registry (first posted 30 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Acceptability of Device (time frame: Up to 17 minutes). The study lists 2 primary outcomes in all. 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 30 Apr 2025.