B3 Buddy for Securing Urinary Drainage Bag to Patient While Walking

Not Applicable

Completed

Conditions: Urinary System Disorder

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

Registration Number: NCT06571058

Lead Sponsor: Ohio State University Comprehensive Cancer Center

Brief 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 41

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

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clinicians (B3 Buddy)	Remove	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.
Clinicians (B3 Buddy)	Educational Intervention	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.
Clinicians (B3 Buddy)	Medical Device Usage and Evaluation	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.
Clinicians (B3 Buddy)	Assistance	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.
Clinicians (B3 Buddy)	Questionnaire Administration	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.
Patients (B3 Buddy)	Educational Intervention	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.
Patients (B3 Buddy)	Medical Device Usage and Evaluation	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.
Patients (B3 Buddy)	Questionnaire Administration	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.
Patients (B3 Buddy)	Walking	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.

Primary Outcome Measures

Name	Time	Method
Acceptability of Device	Up to 17 minutes	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.
Usability of Device	Up to 20 minutes	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.

Secondary Outcome Measures