Early Removal of the Urethral Catheter Following Trans-urethral Resection of Prostate

August 18, 2021 updated by: Saddam Al Demour, University of Jordan

Early Versus Delayed Removal of the Urethral Catheter After Trans Urethral, Randomized Clinical Trial.

Transurethral resection of prostate is the gold standard operation for bladder outflow obstruction due to benign prostatic enlargement. However, catheter removal day is variable. The objective of this study is to compare early and delayed catheter removal groups in terms of, urinary retention after catheter removal, length of hospital stay, weight of resected prostate, duration of resection, peri-operative blood transfusion, and postoperative complications.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This randomized controlled trial will carried out in Urology clinic at Jordan university hospital. Patients with benign prostate hyperplasia will be selected by simple random sampling technique after taking informed consent and will divided into two groups: Group A- early catheter removal group( catheter removed after 24 hours) and Group B-delayed catheter removal group ( catheter removed after 48 hours). in this study we will exclude patients with large post-void urine volume, simultaneous internal urethrotomy and transurethral resection of prostate, co-morbidity( diabetes mellitus, CVA) spinal cord injury, urethral stricture, prostate cancer proved by biopsy and intra-operative complications. Patients will discharged after removal of catheter if they voided successfully.

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Jordan
      • Amman, Jordan, 11942
        • Saddam Al Demour

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

200 adult males from urology clinic atJordan university hospital, with benign prostate hyperplasia who undergo trans-urethral resection of the prostae will be included in this study,

Description

Inclusion Criteria:

- All men with benign prostate hyperplasia who planned to undergo TURP will be included in this study.

Exclusion Criteria:

  • Large post void residual urine.
  • Simultaneous internal urethrotomy and TURP.
  • Uncontrolled Diabetes Mellitus (DM).
  • Cerebrovascular accident accident (CVA).
  • Spinal cord injury.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
group A- early catheter removal)
in group A, we will remove the catheter after 24 h.
Other: removal of the urinary catheter
in group A, we will remove the catheter after 24 h. In group B, we will remove the catheter after 48 h.
Group B- delayed catheter removal
In group B, we will remove the catheter after 48 h.
Other: removal of the urinary catheter
in group A, we will remove the catheter after 24 h. In group B, we will remove the catheter after 48 h.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
urinary retention
Time Frame: after 3 months.
inability to void
after 3 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lower urinary tract symptoms
Time Frame: after 3 months.
urinary symptoms after the procedure.
after 3 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Jordan

Investigators

  • Principal Investigator: Saddam Al Demour, MD, Jordan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 30, 2019

Primary Completion (ACTUAL)

April 30, 2020

Study Completion (ACTUAL)

April 30, 2021

Study Registration Dates

First Submitted

April 16, 2020

First Submitted That Met QC Criteria

April 24, 2020

First Posted (ACTUAL)

April 27, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 20, 2021

Last Update Submitted That Met QC Criteria

August 18, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • sad2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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