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

Sponsor

University of Jordan (Other)

Overall Status

Completed

CT.gov ID

NCT04363970

Collaborator

(none)

200

Enrollment

Location

Actual Duration (Months)

9.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Retention	Other: removal of the urinary catheter

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 Design

Study Type:

Observational

Actual Enrollment :

200 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jun 30, 2019

Actual Primary Completion Date :

Apr 30, 2020

Actual Study Completion Date :

Apr 30, 2021

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

urinary retention [after 3 months.]
inability to void

Secondary Outcome Measures

Lower urinary tract symptoms [after 3 months.]
urinary symptoms after the procedure.

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 90 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Saddam Al Demour	Amman		Jordan	11942

Sponsors and Collaborators

University of Jordan

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Saddam Al Demour, MD, University of Jordan

ClinicalTrials.gov Identifier:

NCT04363970

Other Study ID Numbers:

sad2020

First Posted:

Apr 27, 2020

Last Update Posted:

Aug 20, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Saddam Al Demour, MD, University of Jordan

Benign Prostate Hyperplasia

Urinary retention

Re-catheterization

Additional relevant MeSH terms:

Urinary Retention

Study Results

No Results Posted as of Aug 20, 2021