Clinical trial NCT06571058: B3 Buddy for Securing Urinary Drainage Bag to Patient While Walking
Official title: Feasibility Testing of a Urinary Drainage Bag Securement Device to Improve Patient and Clinician Ambulation Experiences
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary System Disorder
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2024-08-26
Enrollment: 41
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Acceptability of Device
timeFrame: Up to 17 minutes
measure: Usability of Device
timeFrame: Up to 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Karen Meade, MS
role: PRINCIPAL_INVESTIGATOR
References: