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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates a new device called the B3 Buddy, designed to help people with urinary drainage bags maintain proper positioning while walking. The goal is to determine if the B3 Buddy can prevent urine from backing up into the bladder, a common issue when bags are improperly positioned. Individuals with a urinary catheter or urostomy device with a drainage bag who can walk unaided might be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to innovative solutions for urinary health.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on testing a device for urinary drainage, so it's unlikely to require changes to your medication.

What prior data suggests that the B3 Buddy device is safe for securing urinary drainage bags?

Research shows that the B3 Buddy device is easy to use and effective for securing urinary drainage bags while walking. Studies have not identified any serious side effects or problems associated with the device. Designed for flexibility and simplicity, the B3 Buddy helps keep the drainage bag in place, preventing urine from flowing back into the bladder. Overall, available evidence indicates that the device is safe and well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the B3 Buddy because it offers a new approach to managing urinary drainage for patients with urological diseases. Unlike traditional methods, where urinary drainage bags are often cumbersome and limit mobility, the B3 Buddy device secures the bag in a more convenient way, allowing patients to walk more freely. This device can potentially improve patient comfort and mobility, which are key aspects of recovery and quality of life. By focusing on making movement easier, B3 Buddy could represent a significant step forward in patient care for those with urological conditions.

What evidence suggests that the B3 Buddy device is effective for securing urinary drainage bags while walking?

Research has shown that the B3 Buddy device is promising for maintaining the correct position of urinary drainage bags while walking. In one study, all 21 participants found the device acceptable, with confidence levels ranging from 83.9% to 100%, indicating strong support for its effectiveness. In this trial, clinicians and patients will use the B3 Buddy to secure urinary drainage bags during walking. By keeping the drainage bag lower than the bladder, the B3 Buddy helps prevent urine from flowing back into the bladder, which is crucial for proper urine flow. While more clinical data is still being collected, these early results are encouraging. ^{1 2 4 6 7}

Who Is on the Research Team?

Karen Meade, MS

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

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

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

Patient participants must be willing to participate using the B3 Buddy device

I help patients walk as part of my job.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06571058?term=AREA%5BConditionSearch%5D(Urologic%20Diseases)&rank=8&tab=results

B3 Buddy for Securing Urinary Drainage Bag to Patient ... Patients receive a short instructional session, wear the B3 Buddy device to secure urinary drainage bag and walk approximately 90 feet before urinary drainage ...

2. withpower.com withpower.com/trial/phase-urinary-system-disorder-6-2023-81142

B3 Buddy for Urological Diseases · Info for Participants 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 ...

3. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/58/NCT06571058/Prot_SAP_003.pdf

Title of Study: Feasibility Testing of a Urinary Drainage Bag ... To address this, a urinary drainage bag securement device called the Bag Below Bladder (B3) Buddy was invented by the research team. ... During the device testing ...

4. trialstoday.org trialstoday.org/trial/NCT06571058

B3 Buddy for Securing Urinary Drainage Bag to Patient ... Purpose. This clinical trial tests how well the Bag Below Bladder (B3) Buddy device works in securing urinary drainage bags while walking.

5. scholarlyworks.ohiohealth.com scholarlyworks.ohiohealth.com/nursing-articles/1/

"Feasibility Testing of a Nurse-Invented Urinary Drainage ... RESULTS: All 21 patient participants found the B3 Buddy device acceptable, with a 95% confidence interval of 83.9% to 100%, exceeding the 70 ...

6. nursingcenter.com nursingcenter.com/journalarticle?Article_ID=7204878&Journal_ID=54033&Issue_ID=7204852

Feasibility Testing of a Nurse-Invented Urinary Drainage ... This B3 Buddy device was found to be acceptable and usable to the end-users who participated in this study. The inventors are now seeking a manufacturer ...

7. journals.sagepub.com journals.sagepub.com/doi/10.1177/17449871231194121

Perspectives: Delving into the experience of a nurse inventor The B3 Buddy is designed to be a flexible, easy to use, and safe device to help patients and frontline clinicians keep catheter drainage bags at ...