N/A
N=41
B3 Buddy for Securing Urinary Drainage Bag to Patient While Walking
Urinary System Disorder
Bottom Line
View on ClinicalTrials.gov: NCT06571058 ↗Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Acceptability of Device — 100 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Assistance (Other); Educational Intervention (Other); Medical Device Usage and Evaluation (Device); Medical Device Usage and Evaluation (Other); Questionnaire Administration (Other); Remove (Procedure); Walking (Other)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Ohio State University Comprehensive Cancer Center
- Primary completion
- Nov 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Acceptability of Device |
100 | — |
| PRIMARY Usability of Device |
90.1 | — |
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. 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.
Eligibility Criteria
Inclusion Criteria
- 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
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT06571058). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.