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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2024-04927 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Assistance | Other | Assist patient with walking approximately 90 feet |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen Meade, MS | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
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| Label | URL |
|---|---|
| The Jamesline | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Clinicians (B3 Buddy) | 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. Assistance: Assist patient with walking approximately 90 feet Educational Intervention: Receive a short instructional session Medical Device Usage and Evaluation: Secure the urinary drainage bag to the patient using the B3 Buddy device Questionnaire Administration: Ancillary studies Remove: Remove the device and return urinary drainage bag to the standard position |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 12, 2023 |
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| Educational Intervention | Other | Receive a short instructional session |
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| Medical Device Usage and Evaluation | Device | Wear the B3 Buddy device |
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| Medical Device Usage and Evaluation | Other | Secure the urinary drainage bag to the patient using the B3 Buddy device |
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| Questionnaire Administration | Other | Ancillary studies |
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| Remove | Procedure | Remove the device and return urinary drainage bag to the standard position |
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| Walking | Other | Walk approximately 90 feet |
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| FG001 | Patients (B3 Buddy) | 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. Educational Intervention: Receive a short instructional session Medical Device Usage and Evaluation: Wear the B3 Buddy device Questionnaire Administration: Ancillary studies Walking: Walk approximately 90 feet |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Clinicians (B3 Buddy) | 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. Assistance: Assist patient with walking approximately 90 feet Educational Intervention: Receive a short instructional session Medical Device Usage and Evaluation: Secure the urinary drainage bag to the patient using the B3 Buddy device Questionnaire Administration: Ancillary studies Remove: Remove the device and return urinary drainage bag to the standard position |
| BG001 | Patients (B3 Buddy) | 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. Educational Intervention: Receive a short instructional session Medical Device Usage and Evaluation: Wear the B3 Buddy device Questionnaire Administration: Ancillary studies Walking: Walk approximately 90 feet |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Sex demographics were not collected for the Clinicians arm | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Acceptability of device was only measured for patient arm. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 17 minutes |
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| Primary | 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. | Usability of device was only measured for the clinician arm | Posted | Mean | 95% Confidence Interval | score on a scale | Up to 20 minutes |
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Adverse events were collected during intervention for each participant, a time period that lasted up to 20 minutes.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Clinicians (B3 Buddy) | 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. Assistance: Assist patient with walking approximately 90 feet Educational Intervention: Receive a short instructional session Medical Device Usage and Evaluation: Secure the urinary drainage bag to the patient using the B3 Buddy device Questionnaire Administration: Ancillary studies Remove: Remove the device and return urinary drainage bag to the standard position | 0 | 20 | 0 | 20 | 0 | 20 |
| EG001 | Patients (B3 Buddy) | 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. Educational Intervention: Receive a short instructional session Medical Device Usage and Evaluation: Wear the B3 Buddy device Questionnaire Administration: Ancillary studies Walking: Walk approximately 90 feet | 0 | 21 | 0 | 21 | 0 | 21 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Karen Meade | The Ohio State University Comprehensive Cancer Center | 614-366-5060 | Karen.Meade@osumc.edu |
| Mar 24, 2025 |
| Prot_SAP_003.pdf |
| ICF | No | No | Yes | Informed Consent Form: Clinician Consent Form | Jun 12, 2023 | Feb 14, 2025 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Patient Consent Form | Jun 12, 2023 | Feb 14, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| ID | Term |
|---|---|
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D007316 | Insemination, Artificial, Heterologous |
| D018479 | Early Intervention, Educational |
| D004522 | Educational Status |
| D008722 | Methods |
| D010808 | Physical Examination |
| D016138 | Walking |
| ID | Term |
|---|---|
| D007315 | Insemination, Artificial |
| D027724 | Reproductive Techniques, Assisted |
| D012099 | Reproductive Techniques |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
| D007314 | Insemination |
| D012098 | Reproduction |
| D055703 | Reproductive Physiological Phenomena |
| D012101 | Reproductive and Urinary Physiological Phenomena |
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011314 | Preventive Health Services |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008124 | Locomotion |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D015444 | Exercise |
| D009043 | Motor Activity |
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| Between 18 and 65 years |
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| >=65 years |
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