- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01228864
Brody Belt - Alternative Method of Securing a Patient's Urinary Drainage Bag
December 6, 2017 updated by: Roswell Park Cancer Institute
The Brody belt may help improve quality of life in patients using urinary drainage bags.
PURPOSE: This clinical trial studies the Brody belt in improving the quality of life in patients using urinary drainage bags.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
12
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
-
-
New York
-
Buffalo, New York, United States, 14263
- Roswell Park Cancer Institute
-
-
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
->18 years old
-All patients in the urology clinic at Roswell Park who currently use a urinary drainage bag for a period of at least 7 days prior to signing consent for the study and who are expected to use a urinary drainage tube for an additional period of 4 weeks or more based on the diagnosis
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: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Brody Belt
|
survey
|
|
Active Comparator: Conventional Urinary Drainage bag
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Quality of Life
Time Frame: 4 weeks
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Khurshid Guru, MD, Roswell Park Cancer Institute
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)
September 22, 2009
Primary Completion (Actual)
August 15, 2017
Study Completion (Actual)
August 15, 2017
Study Registration Dates
First Submitted
October 25, 2010
First Submitted That Met QC Criteria
October 25, 2010
First Posted (Estimate)
October 27, 2010
Study Record Updates
Last Update Posted (Actual)
December 8, 2017
Last Update Submitted That Met QC Criteria
December 6, 2017
Last Verified
December 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- I 153209
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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