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

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.

Study Overview

• Status: Completed
• Conditions: Urinary System Disorder
• Intervention / Treatment: Other: Questionnaire Administration; Other: Assistance; Other: Educational Intervention; Other: Medical Device Usage and Evaluation; Procedure: Remove; Device: Medical Device Usage and Evaluation; Other: 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.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Questionnaire Administration; Ancillary studies; Other: Assistance; Assist patient with walking approximately 90 feet; Other Names: Aid; Assist; Help; Other: Educational Intervention; Receive a short instructional session; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational; Other: Medical Device Usage and Evaluation; Secure the urinary drainage bag to the patient using the B3 Buddy device; Procedure: Remove; Remove the device and return urinary drainage bag to the standard position; Other Names: Removal
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.	Other: Questionnaire Administration; Ancillary studies; Other: Educational Intervention; Receive a short instructional session; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational; Device: Medical Device Usage and Evaluation; Wear the B3 Buddy device; Other: Walking; Walk approximately 90 feet; Other Names: Ambulation; By Foot; On Foot; Walk

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Up to 20 minutes

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Investigators: Principal Investigator: Karen Meade, MS, Ohio State University Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2023
• Primary Completion (Actual): November 17, 2023
• Study Completion (Actual): November 17, 2023

Study Registration Dates

• First Submitted: June 27, 2024
• First Submitted That Met QC Criteria: August 21, 2024
• First Posted (Actual): August 26, 2024

Study Record Updates

• Last Update Posted (Actual): April 30, 2025
• Last Update Submitted That Met QC Criteria: April 28, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urologic Diseases
• Other Study ID Numbers: OSU-22357; NCI-2024-04927 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No