NCT02602132

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 4, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 11, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 9, 2021

Completed
Last Updated

August 30, 2021

Status Verified

August 1, 2021

Enrollment Period

1.1 years

First QC Date

November 4, 2015

Last Update Submit

August 24, 2021

Conditions

Complication of Urinary Catheter

Keywords

INDWELLING URINARY CATHETERCLAMPINGREMOVAL

Outcome Measures

Primary Outcomes (1)

  • Incidence of recatheterization

    24h

Study Arms (2)

Clamping group

EXPERIMENTAL

Indwelling urinary catheter is clamped before removal and unclamped when the patient expresses his desire to urinate.

Procedure: Clamping

Free drainage group

NO INTERVENTION

The urinary catheter will be removed without prior clamping.

Interventions

ClampingPROCEDURE

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

Clamping group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Fundación Alcorcón

Alcorcón, Madrid, 28922, Spain

Location

Related Publications (1)

  • Ellahi A, Stewart F, Kidd EA, Griffiths R, Fernandez R, Omar MI. Strategies for the removal of short-term indwelling urethral catheters in adults. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD004011. doi: 10.1002/14651858.CD004011.pub4.

    PMID: 34184246DERIVED

MeSH Terms

Interventions

Constriction

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • David Guadarrama Ortega, RN

    HUFA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Registered Nurse

Study Record Dates

First Submitted

November 4, 2015

First Posted

November 11, 2015

Study Start

March 1, 2016

Primary Completion

April 1, 2017

Study Completion

February 9, 2021

Last Updated

August 30, 2021

Record last verified: 2021-08

Locations

ES(1)