Improving Sensitivity of Urine Cytology for Bladder Cancer

NCT01826097 | Withdrawn DMC

• 1 other identifier: NA_00067544
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bladder Cancer

Keywords

Cytology; Whole body massage vibration

Outcome Measures

Primary Outcomes (1)

• Number of Cancer Cells

  Number of Cancer Cells in a 50 ml Urine

  up to 24 weeks

Study Arms (1)

Vibration

EXPERIMENTAL

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

Interventions

La-Z-Boy Massage Chair Vibration Effect on Bladder Cancer Cell Concentration DEVICE

Vibration

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Trinity Bivalacqua, MD/PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• John J Kim, BS

  Johns Hopkins University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2013
• First Posted: April 8, 2013
• Study Start: January 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: February 1, 2018

Record last verified: 2018-01

Locations

US (1)