Impact of Atkinson Product Design Urinary Slide Valve Versus Standard Catheter Drainage System on Social Functioning
| Status: | Withdrawn |
|---|---|
| Conditions: | Other Indications, Urology, Urinary Tract Infections |
| Therapuetic Areas: | Nephrology / Urology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/6/2017 |
| Start Date: | February 2010 |
| End Date: | February 2010 |
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.
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.
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.
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
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