A Phase 4 interventional study of Truvalve and Control (catheter drainage bag) in Urinary Catheterization and Urinary Tract Infections, sponsored by The Cleveland Clinic. Withdrawn at 2 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-01-05.
Sponsored by The Cleveland Clinic · Phase 4 and Interventional
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.
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.
753 studies on the registry are indexed under Urinary Tract Infections; 128 are open to participants now.
Browse Urinary Tract Infections studies →The Cleveland Clinic is the lead sponsor of 818 studies on the registry; 118 are open to participants now.
Of its 89 completed or terminated interventional studies of FDA-regulated products, 72 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Atkinson Product Design urinary slide valve on the catheter
Device: Truvalve
Drainage bag on the catheter
Other: Control (catheter drainage bag)
Atkinson Product Design urinary slide valve
urinary catheter drainage bag
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
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
This study is withdrawn, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
The Cleveland Clinic