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NCT04363970 Clinical Trial

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

Urinary Retention Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04363970
Other study ID # sad2020
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 30, 2019
Est. completion date April 30, 2021

Study information
Verified date August 2021
Source University of Jordan
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date April 30, 2021
Est. primary completion date April 30, 2020
Accepts healthy volunteers No
Gender Male
Age group 45 Years to 90 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Jordan Saddam Al Demour Amman

Sponsors (1)
Lead Sponsor Collaborator
University of Jordan

Country where clinical trial is conducted

Jordan, 

Outcome
Type Measure Description Time frame Safety issue
Primary urinary retention inability to void after 3 months.
Secondary Lower urinary tract symptoms urinary symptoms after the procedure. after 3 months.
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