B3 Buddy for Urological Diseases

Overseen By The Ohio State University Comprehensive Cancer Center

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University Comprehensive Cancer Center

Disqualifiers: Multiple drainage bags

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

41 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Karen Meade, MS

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

This trial is for individuals with urinary tract disorders or urological diseases who use a urinary drainage bag. Participants should be able to walk and willing to use the B3 Buddy device to secure their drainage bags while walking.

Inclusion Criteria

I am a clinician who speaks English.

Clinician participants must be able to comprehend and agree to consent

Patient participants must be able to read and complete the Acceptability of Implementation Measure (AIM) survey

Exclusion Criteria

Patient participants with more than one urinary-like drainage bags will be excluded due to 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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Instructional Session and Device Use

Participants receive a short instructional session and use the B3 Buddy device to secure urinary drainage bag while walking

1 day

1 visit (in-person)

Follow-up

Participants are monitored for acceptability and usability of the device

1 day

Treatment Details

Interventions

• B3 Buddy

Trial Overview The study evaluates the effectiveness of the B3 Buddy, a device designed to hold urinary drainage bags at the correct level below the bladder during walking, which may improve comfort and prevent urine backflow.

Participant Groups

Group I: Patients (B3 Buddy) Experimental Treatment 4 Interventions

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.

Group II: Clinicians (B3 Buddy) Experimental Treatment 5 Interventions

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 Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+