Quality of LifeNCT01228864
Brody Belt - Alternative Method of Securing a Patient's Urinary Drainage Bag
A study testing quality of life in people with Quality of Life, run by Roswell Park Cancer Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life
- What is being tested?
- quality of life
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2009to 15 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ->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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263
About this study
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.
- Conditions
- Quality of Life
- Being tested
- quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quality of lifeProcedure or surgery
survey
Quality of lifeProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Brody Belt | Experimental | Not described Receives: Procedure: quality of life |
| Conventional Urinary Drainage bag | Active comparator | Not described Receives: Procedure: Quality of life |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2010 (estimated)
- Study start22 Sep 2009
- Primary completion15 Aug 2017
- Study completion15 Aug 2017
Why it stopped: low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Khurshid Guru, MD, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01228864
- Sponsor's protocol ID
- I 153209
- Status last verified
- Dec 2017
- First submitted
- 25 Oct 2010
- Last updated
- 8 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brody Belt - Alternative Method of Securing a Patient's Urinary Drainage Bag
- ClinicalTrials.gov ID
- NCT01228864
- Acronym / sponsor ID
- I 153209
- Conditions
- Quality of Life
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low accrual
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- 22 Sep 2009 (actual)
- Primary completion
- 15 Aug 2017 (actual)
- Study completion
- 15 Aug 2017 (actual)
- First posted
- 27 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brody Belt | Experimental | Procedure: quality of life |
| Conventional Urinary Drainage bag | Active comparator | Procedure: Quality of life |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ->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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| quality of lifesurvey | Procedure or surgery | Brody Belt |
| Quality of life | Procedure or surgery | Conventional Urinary Drainage bag |
Primary outcome
Quality of Life
Time frame: 4 weeks
Results and safety
The study was stopped early (reason given: low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Khurshid Guru, MD principal investigator
Roswell Park Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing quality of life in people with Quality of Life, run by Roswell Park Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: low accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2017.