- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02602132
Clamping vs. Free Drainage Before the Removal of Short-term Indwelling Urethral Catheters in Internal Medicine Patients.
The study will be conducted at University Hospital Alcorcón Foundation, belonging to the public network of hospitals of Madrid Health Service.
The aim of this study is to evaluate the effects of clamping the urethral catheter prior to removal and determine which of the two options (clamping or free drainage) is the most recommended for removal of bladder catheterization in adults.
The interest of this study is given by the importance of proper handling of catheterization in the health of patients admitted to a hospital and are subjected to this technique. Increase its interest the need for implementation of evidence-based care, and limited scientific literature on the subject.
The study population will be patients undergoing short-term urethral catheterization at the Internal Medicine Service in the University Hospital Alcorcón Foundation.
The methodology of the study is experimental, randomized clinical trial without drug type. Interventions (prior clamped and free drainage) will be assigned in a randomized manner.
Interventions and data collection of patients who met the inclusion criteria to join the study will be conducted during 2016 and the first quarter of 2017. It is planned to present results at the end of 2017.
Keywords: BLADDER TRAINING, INDWELLING CATHETER, URINARY CATHETER, URETHRAL CATHETER, CLAMPING, REMOVAL, ACUTE URINARY RETENTION.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Madrid
-
Alcorcon, Madrid, Spain, 28922
- Hospital Universitario Fundacion Alcorcon
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adult patients of both sexes, aged between 18 and 85 years who require IUC 18 short-term (1 to 14 days) in the units of internal medicine at University Hospital Alcorcón Foundation.
Patients who express a desire to participate in the study by signing the informed consent.
Exclusion Criteria:
- Patients with permanent long-term (15 days or more) urinary catheter. Patients with recurrent episodes of UTI, which has submitted episodes of urinary retention in the last month, or who have urologic pathology.
Patients with cognitive impairments that hinder communication with the medical staff.
Disoriented patients in person, time and place. Anatomical and physiological genito-urinary system Alterations Patients taking a drug that affects the bladder and kidney function the week prior to catheterization.
Pregnant patients. Patients with a known history of benign prostatic hyperplasia.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Clamping group
Indwelling urinary catheter is clamped before removal and unclamped when the patient expresses his desire to urinate.
|
To clamp before the removal of short-term indwelling urethral catheters
|
No Intervention: Free drainage group
The urinary catheter will be removed without prior clamping.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of recatheterization
Time Frame: 24h
|
24h
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: David Guadarrama Ortega, RN, HUFA
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 15/63
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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