NCT01228864

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable quality-of-life

Timeline
Completed

Started Sep 2009

Longer than P75 for not_applicable quality-of-life

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 22, 2009

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 25, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 27, 2010

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2017

Completed
Last Updated

December 8, 2017

Status Verified

December 1, 2017

Enrollment Period

7.9 years

First QC Date

October 25, 2010

Last Update Submit

December 6, 2017

Conditions

Quality of Life

Outcome Measures

Primary Outcomes (1)

  • Quality of Life

    4 weeks

Study Arms (2)

Brody Belt

EXPERIMENTAL
Procedure: quality of life

Conventional Urinary Drainage bag

ACTIVE COMPARATOR
Procedure: Quality of life

Interventions

Quality of lifePROCEDURE

survey

Brody Belt

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Interventions

Quality of Life

Intervention Hierarchy (Ancestors)

Health StatusDemographyEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Khurshid Guru, MD

    Roswell Park Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2010

First Posted

October 27, 2010

Study Start

September 22, 2009

Primary Completion

August 15, 2017

Study Completion

August 15, 2017

Last Updated

December 8, 2017

Record last verified: 2017-12

Locations

US(1)