NCT06571058

B3 Buddy for Securing Urinary Drainage Bag to Patient While Walking

Feasibility Testing of a Urinary Drainage Bag Securement Device to Improve Patient and Clinician Ambulation Experiences

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

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.

Conditions

• Urinary System Disorder

Interventions

Type	Name	Description
OTHER	Assistance	Assist patient with walking approximately 90 feet
OTHER	Educational Intervention	Receive a short instructional session
DEVICE	Medical Device Usage and Evaluation	Wear the B3 Buddy device
OTHER	Medical Device Usage and Evaluation	Secure the urinary drainage bag to the patient using the B3 Buddy device
OTHER	Questionnaire Administration	Ancillary studies
PROCEDURE	Remove	Remove the device and return urinary drainage bag to the standard position
OTHER	Walking	Walk approximately 90 feet

Timeline

• Start date: 2023-07-27
• Primary completion: 2023-11-17
• Completion: 2023-11-17
• First posted: 2024-08-26
• Last updated: 2025-04-30
• Results posted: 2025-04-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study