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

NCT ID: NCT01063452

Last Updated: 2017-01-05

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2010-02-28

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

Truvalve

Atkinson Product Design urinary slide valve on the catheter

Group Type: EXPERIMENTAL

Truvalve

Intervention Type: DEVICE

Atkinson Product Design urinary slide valve

Control

Drainage bag on the catheter

Group Type: ACTIVE_COMPARATOR

Control (catheter drainage bag)

Intervention Type: OTHER

urinary catheter drainage bag

Interventions

Truvalve

Atkinson Product Design urinary slide valve

Intervention Type: DEVICE

Control (catheter drainage bag)

urinary catheter drainage bag

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

University of Minnesota

Principal Investigators

Manoj Monga, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

Urology Associates

Edina, Minnesota, United States

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

Truvalve

Identifier Type: -

Identifier Source: org_study_id