Impact of Atkinson Product Design Urinary Slide Valve Versus Standard Catheter Drainage System on Social Functioning

This study has been completed.
Sponsor:
Information provided by:
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01063452
First received: February 3, 2010
Last updated: August 12, 2013
Last verified: February 2010
  Purpose

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.


Condition Intervention Phase
Urinary Catheterization
Urinary Tract Infections
Device: Truvalve
Other: Control (catheter drainage bag)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Impact of Atkinson Product Design Urinary Slide Valve Versus Standard Catheter Drainage System on Social Functioning

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 100
Study Start Date: February 2010
Study Completion Date: December 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Truvalve
Atkinson Product Design urinary slide valve on the catheter
Device: Truvalve
Atkinson Product Design urinary slide valve
Active Comparator: Control
Drainage bag on the catheter
Other: Control (catheter drainage bag)
urinary catheter drainage bag

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients undergoing brachytherapy or cryotherapy for prostate cancer
  2. Patients undergoing thermal therapy for benign prostatic hyperplasia
  3. Patients undergoing catheterization to relieve urinary retention

Exclusion Criteria:

  1. Patients with neurogenic bladder
  2. Patients with urinary tract infection
  3. Patients with gross hematuria
  4. Patients undergoing surgery with risk of urinary leak (ex: urethroplasty, radical prostatectomy, bladder repair)
  5. Female patients
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01063452

Locations
United States, Minnesota
Urology Associates
Edina, Minnesota, United States, 55435
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Manoj Monga, MD University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

Responsible Party: Dr. Manoj Monga, University of Minnesota
ClinicalTrials.gov Identifier: NCT01063452     History of Changes
Other Study ID Numbers: Truvalve
Study First Received: February 3, 2010
Last Updated: August 12, 2013
Health Authority: United States: University of Minnesota IRB

Keywords provided by The Cleveland Clinic:
Urinary Catheterization
Urinary Tract Infections

Additional relevant MeSH terms:
Urinary Tract Infections
Infection
Urologic Diseases

ClinicalTrials.gov processed this record on July 20, 2014