Study Stopped
This trial was never initiated due to inability to obtain the device
Impact of Atkinson Product Design Urinary Slide Valve Versus Standard Catheter Drainage System on Social Functioning
1 other identifier
interventional
N/A
1 country
2
Brief 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). Secondary objectives include assessing the impact of the device on bacteruria and evaluating the impact of the primary treatment on ADL and QOL.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Feb 2010
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 3, 2010
CompletedFirst Posted
Study publicly available on registry
February 5, 2010
CompletedJanuary 5, 2017
January 1, 2017
Same day
February 3, 2010
January 4, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
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.
At time of catheter removal
Study Arms (2)
Truvalve
EXPERIMENTALAtkinson Product Design urinary slide valve on the catheter
Control
ACTIVE COMPARATORDrainage bag on the catheter
Interventions
Eligibility Criteria
You may qualify if:
- Patients undergoing brachytherapy or cryotherapy for prostate cancer
- Patients undergoing thermal therapy for benign prostatic hyperplasia
- Patients undergoing catheterization to relieve urinary retention
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Urology Associates
Edina, Minnesota, 55435, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Manoj Monga, MD
University of Minnesota
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 3, 2010
First Posted
February 5, 2010
Study Start
February 1, 2010
Primary Completion
February 1, 2010
Study Completion
February 1, 2010
Last Updated
January 5, 2017
Record last verified: 2017-01