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OpenTrials
Completed

NCT Number: NCT06571058

B3 Buddy for Securing Urinary Drainage Bag to Patient While Walking

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.

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Key information

Conditions

Urinary System Disorder Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Assistance

Other

Assist patient with walking approximately 90 feet

Other names: Aid, Assist, Help

Educational Intervention

Other

Receive a short instructional session

Other names: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Medical Device Usage and Evaluation

Device

Wear the B3 Buddy device

Medical Device Usage and Evaluation

Other

Secure the urinary drainage bag to the patient using the B3 Buddy device

Questionnaire Administration

Other

Ancillary studies

Remove

Procedure

Remove the device and return urinary drainage bag to the standard position

Other names: Removal

walking

Other

Walk approximately 90 feet

Other names: Ambulation, By Foot, On Foot, Walk

Primary outcomes

  1. Acceptability of Device

    Time frame: 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.

  2. Usability of Device

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 26, 2024
Registry last updated
Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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