Clamping vs. Free Drainage Before the Removal of Short-te... | NCT02602132

Studies
Clamping vs. Free Drainage Before the Removal of Short-term Indwelling Urethral Catheters in Internal Medicine Patients.

NCT02602132

Sponsor

David Guadarrama-Ortega

Status

Terminated

Last Update Posted

Aug 30, 2021Actual

Enrollment

17Actual

Phase

Not Applicable

Conditions

Complication of Urinary Catheter

Interventions

Clamping

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not enough participants. very slow and poor recruitment

Expanded Access Info

Start Date

Mar 2016

Primary Completion Date

Apr 2017Actual

Completion Date

Feb 9, 2021Actual

First Submitted Date

Nov 4, 2015

First Submission Date that Met QC Criteria

Nov 10, 2015

First Posted Date

Nov 11, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 24, 2021

Last Update Posted Date

Aug 30, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

17Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Clamping	Procedure	To clamp before the removal of short-term indwelling urethral catheters	Clamping group

Measure	Description	Time Frame
Incidence of recatheterization		24h

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
David Guadarrama Ortega, RN	HUFA	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Universitario Fundación Alcorcón		Alcorcón	Madrid	28922	Spain

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34184246	Derived	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.