B3 Buddy for Securing Urinary Drainage Bag to Patient While Walking

The Ohio State University

Status: Enrolling

Conditions: Urinary System Disorder

Treatments: Other: Questionnaire Administration; Other: Assistance; Other: Walking; Other: Medical Device Usage and Evaluation; Other: Educational Intervention; Procedure: Remove

Study type: Interventional

Funder types: Other

Identifiers

NCT06571058

OSU-22357

NCI-2024-04927 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Clinicians (B3 Buddy)

Experimental group

Description:

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.

Treatment:

Other: Medical Device Usage and Evaluation

Procedure: Remove

Other: Educational Intervention

Other: Medical Device Usage and Evaluation

Other: Questionnaire Administration

Other: Assistance

Patients (B3 Buddy)

Experimental group

Description:

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.

Treatment:

Other: Educational Intervention

Other: Walking

Other: Questionnaire Administration