Urinary CatheterizationPhase 4NCT01063452
Impact of Atkinson Product Design Urinary Slide Valve Versus Standard Catheter Drainage System on Social Functioning
A Phase 4 study testing Truvalve in people with Urinary Catheterization and Urinary Tract Infections, run by The Cleveland Clinic at 2 sites in United States.
Trial summary
The primary objective of this study is to evaluate the impact of the Atkinson Product Design urinary slide valve on patient morbidity and freedom as measured by impact on activities of daily living (ADL) and quality of life (QOL). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Urinary Catheterization, Urinary Tract Infections
- What is being tested?
- Truvalve
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2010to Feb 2010
- Phase
- Phase 4
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing brachytherapy or cryotherapy for prostate cancer
- Patients undergoing thermal therapy for benign prostatic hyperplasia
- Patients undergoing catheterization to relieve urinary retention
Who cannot join
- Patients with neurogenic bladder
- Patients with urinary tract infection
- Patients with gross hematuria
- Patients undergoing surgery with risk of urinary leak (ex: urethroplasty, radical prostatectomy, bladder repair)
- Female patients
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Urology Associates
Edina, Minnesota, 55435
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
The primary objective of this study is to evaluate the impact of the Atkinson Product Design urinary slide valve on patient morbidity and freedom as measured by impact on activities of daily living (ADL) and quality of life (QOL). Secondary objectives include assessing the impact of the device on bacteruria and evaluating the impact of the primary treatment on ADL and QOL.
Read the detailed description
Several indications exist in urologic practice where urinary drainage via a urethral catheter is required and an estimated 4 million patients in the United States undergo urinary catheterization per year.(1) Though it is common for urine to be continually collected in a bag attached to the catheter by plastic tubing, catheter valves offer an alternative method of storing and voiding urine. Catheter valves are small devices that fit into the external end of the urethral catheter. Rather than continuous drainage, urine is stored in the bladder and emptied on regular intervals by opening the valve.
This method of drainage may offer several benefits including preserving bladder capacity, function and tone, reducing catheter blockage in cases of urine bacterial colonization, and decreasing traction forces on the bladder neck by removing the downward weight of a collecting bag.(2-4) The use of a catheter valve may offer improvements in social functioning and mobility.(5) Studies to date suggest that catheter valves are well tolerated by patients, but these studies have used non-standardized questionnaires and have not assessed overall quality of life.(5, 6) Additionally, there may be an associated cost benefit to utilizing catheter valves compared to drainage bags.(5)
Further study in this area, focusing on quality of life and social functioning, will enable the clinician to better counsel patients on the risks and benefits of the various methods of urinary drainage.
- Conditions
- Urinary Catheterization, Urinary Tract Infections
- Being tested
- Truvalve, Control (catheter drainage bag)
- Keywords
- Urinary Catheterization, Urinary Tract Infections
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TruvalveDevice
Atkinson Product Design urinary slide valve
Control (catheter drainage bag)Other
urinary catheter drainage bag
| Study group | Role | What they receive |
|---|---|---|
| Truvalve | Experimental | Atkinson Product Design urinary slide valve on the catheter Receives: Device: Truvalve |
| Control | Active comparator | Drainage bag on the catheter Receives: Other: Control (catheter drainage bag) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this study is to evaluate the impact of the Atkinson Product Design urinary slide valve on patient morbidity and freedom as measured by impact on activities of daily living (ADL) and quality of life (QOL).
Measured: 1 month after catheter removal
Secondary outcomes (1)
Secondary objectives include assessing the impact of the device on bacteruria and evaluating the impact of the primary treatment on ADL and QOL.
Measured: At time of catheter removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionFeb 2010
- Study completionFeb 2010
Why it stopped: This trial was never initiated due to inability to obtain the device
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary CatheterizationStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Investigators
- Manoj Monga, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01063452
- Sponsor's protocol ID
- Truvalve
- Status last verified
- Jan 2017
- First submitted
- 3 Feb 2010
- Last updated
- 5 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Atkinson Product Design Urinary Slide Valve Versus Standard Catheter Drainage System on Social Functioning
- ClinicalTrials.gov ID
- NCT01063452
- Acronym / sponsor ID
- Truvalve
- Conditions
- Urinary Catheterization, Urinary Tract Infections
- Keywords
- Urinary Catheterization, Urinary Tract Infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This trial was never initiated due to inability to obtain the device
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 5 Feb 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 primary objective of this study is to evaluate the impact of the Atkinson Product Design urinary slide valve on patient morbidity and freedom as measured by impact on activities of daily living (ADL) and quality of life (QOL). Secondary objectives include assessing the impact of the device on bacteruria and evaluating the impact of the primary treatment on ADL and QOL.
Detailed description
Several indications exist in urologic practice where urinary drainage via a urethral catheter is required and an estimated 4 million patients in the United States undergo urinary catheterization per year.(1) Though it is common for urine to be continually collected in a bag attached to the catheter by plastic tubing, catheter valves offer an alternative method of storing and voiding urine. Catheter valves are small devices that fit into the external end of the urethral catheter. Rather than continuous drainage, urine is stored in the bladder and emptied on regular intervals by opening the valve.
This method of drainage may offer several benefits including preserving bladder capacity, function and tone, reducing catheter blockage in cases of urine bacterial colonization, and decreasing traction forces on the bladder neck by removing the downward weight of a collecting bag.(2-4) The use of a catheter valve may offer improvements in social functioning and mobility.(5) Studies to date suggest that catheter valves are well tolerated by patients, but these studies have used non-standardized questionnaires and have not assessed overall quality of life.(5, 6) Additionally, there may be an associated cost benefit to utilizing catheter valves compared to drainage bags.(5)
Further study in this area, focusing on quality of life and social functioning, will enable the clinician to better counsel patients on the risks and benefits of the various methods of urinary drainage.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Truvalve | Experimental | Device: TruvalveAtkinson Product Design urinary slide valve on the catheter |
| Control | Active comparator | Other: Control (catheter drainage bag)Drainage bag on the catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing brachytherapy or cryotherapy for prostate cancer
- Patients undergoing thermal therapy for benign prostatic hyperplasia
- Patients undergoing catheterization to relieve urinary retention
Key exclusion criteria (5 listed)
- Patients with neurogenic bladder
- Patients with urinary tract infection
- Patients with gross hematuria
- Patients undergoing surgery with risk of urinary leak (ex: urethroplasty, radical prostatectomy, bladder repair)
- Female patients
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 |
|---|---|---|
| TruvalveAtkinson Product Design urinary slide valve | Device | Truvalve |
| Control (catheter drainage bag)urinary catheter drainage bag | Other | Control |
Primary outcome
The primary objective of this study is to evaluate the impact of the Atkinson Product Design urinary slide valve on patient morbidity and freedom as measured by impact on activities of daily living (ADL) and quality of life (QOL).
Time frame: 1 month after catheter removal
1 secondary outcome
Secondary objectives include assessing the impact of the device on bacteruria and evaluating the impact of the primary treatment on ADL and QOL.
Time frame: At time of catheter removal
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 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.
Manoj Monga, MD principal investigator
University of Minnesota
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Truvalve in people with Urinary Catheterization and Urinary Tract Infections, run by The Cleveland Clinic at 2 sites 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 3 inclusion and 5 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: withdrawn, as of the sponsor's last update on 5 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
The primary objective of this study is to evaluate the impact of the Atkinson Product Design urinary slide valve on patient morbidity and freedom as measured by impact on activities of daily living (ADL) and quality of life (QOL). (time frame: 1 month after catheter removal). 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 5 Jan 2017.