B3 Buddy for Securing Urinary Drainage Bag to Patient While Walking
Purpose
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.
Condition
- Urinary System Disorder
Eligibility
- Eligible Ages
- All ages
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Supportive Care
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Clinicians (B3 Buddy) |
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. |
|
|
Experimental Patients (B3 Buddy) |
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. |
|
Recruiting Locations
Columbus, Ohio 43210
More Details
- NCT ID
- NCT06571058
- Status
- Recruiting
- Sponsor
- Ohio State University Comprehensive Cancer Center
Study Contact
The Ohio State University Comprehensive Cancer Center800-293-5066
OSUCCCClinicaltrials@osumc.edu
Detailed Description
PRIMARY OBJECTIVES: I. 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.