Improving Sensitivity of Urine Cytology for Bladder Cancer

January 30, 2018 updated by: Johns Hopkins University

Non-Invasive Vibrational Device to Improve Sensitivity of Urine Cytology for Bladder Cancer

Can a commercially available vibrating chair increase the number of urothelial cells in a urine sample of healthy participants non-invasively? The investigators plan is participants will alternate 15 minutes of drinking eight fluid ounces of water and 15 minutes of sitting in the vibrating chair for one hour. The control group will alternate 15 minutes of drinking eight fluid ounces of water and 15 minutes of sitting in a non-vibrating chair for one hour. Then, urine samples will be collected and examined for urothelial cell concentration for both groups.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Only adult male subjects who will not have surgery within a period of 2 weeks.
  • Over the age of 18
  • Have had a confirmed diagnosis of stage 0-4 transitional cell carcinoma within the last 30 days

Exclusion Criteria:

  • Cognitive impairment resulting in the inability to give informed consent
  • Lack of spoken and written English resulting in the inability to give informed consent
  • Presence of infectious disease
  • Insulin dependent diabetes mellitus
  • Endogenous osteosynthetical material implants
  • Knee or hip prosthesis
  • Pacemaker
  • Epilepsy
  • Musculo-skeletal disorders
  • Weight in excess of 250 pounds
  • Poor circulation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vibration
Whole body vibration applied to a group of 20 bladder cancer patients.
Device: La-Z-Boy Massage Chair Vibration Effect on Bladder Cancer Cell Concentration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Cancer Cells
Time Frame: up to 24 weeks
Number of Cancer Cells in a 50 ml Urine
up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Investigators

  • Principal Investigator: Trinity Bivalacqua, MD/PhD, Johns Hopkins University
  • Study Chair: John J Kim, BS, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2013

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

April 1, 2013

First Submitted That Met QC Criteria

April 3, 2013

First Posted (Estimate)

April 8, 2013

Study Record Updates

Last Update Posted (Actual)

February 1, 2018

Last Update Submitted That Met QC Criteria

January 30, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NA_00067544

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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