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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02602132
Other study ID # 15/63
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date March 2016
Est. completion date February 9, 2021

Study information

Verified date August 2021
Source Hospital Universitario Fundación Alcorcón
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Terminated
Enrollment 17
Est. completion date February 9, 2021
Est. primary completion date April 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Clamping
To clamp before the removal of short-term indwelling urethral catheters

Locations

Country Name City State
Spain Hospital Universitario Fundación Alcorcón Alcorcon Madrid

Sponsors (1)

Lead Sponsor Collaborator
David Guadarrama-Ortega

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of recatheterization 24h
See also
  Status Clinical Trial Phase
Completed NCT01865708 - Pilot Study of the Safety of a Daily Ethanol Lock for Urinary Catheters in Critically Ill Children Phase 1