B3 Buddy for Securing Urinary Drainage Bag to Patient While Walking

NCT06571058 | Completed Results DMC FDA Device

• 2 other identifiers: OSU-22357NCI-2024-04927
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary System Disorder

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Clinicians (B3 Buddy)

EXPERIMENTAL

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

Patients (B3 Buddy)

EXPERIMENTAL

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: Educational Intervention; Device: Medical Device Usage and Evaluation; Other: Questionnaire Administration; Other: Walking

Interventions

Assistance OTHER

Assist patient with walking approximately 90 feet

Also known as: Aid, Assist, Help

Clinicians (B3 Buddy)

Educational Intervention OTHER

Receive a short instructional session

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Clinicians (B3 Buddy); Patients (B3 Buddy)

Medical Device Usage and Evaluation DEVICE

Wear the B3 Buddy device

Patients (B3 Buddy)

Questionnaire Administration OTHER

Ancillary studies

Clinicians (B3 Buddy); Patients (B3 Buddy)

Remove PROCEDURE

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

Also known as: Removal

Clinicians (B3 Buddy)

Walking OTHER

Walk approximately 90 feet

Also known as: Ambulation, By Foot, On Foot, Walk

Patients (B3 Buddy)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

MeSH Terms

Conditions

Urologic Diseases

Interventions

Insemination, Artificial, Heterologous; Early Intervention, Educational; Educational Status; Methods; Physical Examination; Walking

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Insemination, Artificial; Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Investigative Techniques; Insemination; Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Diagnostic Techniques and Procedures; Diagnosis; Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity

Results Point of Contact

• Title: Karen Meade
• Organization: The Ohio State University Comprehensive Cancer Center

Karen.Meade@osumc.edu

614-366-5060

Study Officials

• Karen Meade, MS

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: August 26, 2024
• Study Start: July 27, 2023
• Primary Completion: November 17, 2023
• Study Completion: November 17, 2023
• Last Updated: April 30, 2025
• Results First Posted: April 30, 2025

Record last verified: 2025-04

Locations

US (1)