The Safety and Efficacy of Addition of Gentamicin on Irrigation Fluid in Prevention of Post-Transurethral Resection of the Prostate Infectious Complications.

The Safety and Efficacy of Addition of Gentamicin on Irrigation Fluid in Prevention of Post-Transurethral Resection of the Prostate Infectious Complications: A Prospective Randomized Double Blinded Placebo Controlled Pilot Trial.

The aim of this clinical study is to evaluate the safety and efficacy of addition of gentamicin on irrigation fluid during trans-urethral resection of the prostate (TURP) and its role in reduction of post-TURP infectious complications.

the participants will be randomly divided into two groups: Group A (gentamicin group) and group B (Placebo).

Study Overview

• Status: Recruiting
• Conditions: Post-TURP Infectious Complications
• Intervention / Treatment: Procedure: Transurethral resection of the prostate (TURP); Drug: Gentamicin; Drug: normal saline

Detailed Description

220 patients scheduled for TURP for the management of urinary retention or LUTS will be included and divided into two groups; "Group A" includes 110 patients who will undergo TURP with addition of one ampoule of gentamicin 80 mg (2ml) /3L of irrigation solution (the first 9 Liters during resection and the first 6 Liters during post-operative irrigation) and "Group B" includes 110 patients who will undergo TURP with addition of normal saline (2 ml) as a placebo on the irrigation solution. Determination of Gentamicin in human serum using HPLC/UV after Chemical Derivatization will be done using the method of Barends et al (Barends, Brouwers, & Hulshoff, 1987). Both groups will be compared as regards the demographic data, post-operative pyuria and bacteruria (1 week after removal of urethral catheter), fever, and/or sepsis.

• Study Type: Interventional
• Enrollment (Estimated): 220
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed G. Zoeir, Ph D; Phone Number: +2 +201008634198; Email: drahmedzoeir27@gmail.com
• Study Contact Backup: Name: Ahmed A. Eissa, Ph D; Phone Number: +2 01110304666; Email: ahmed.taha.eissa@gmail.com

Study Locations

• Egypt
  • Outside U.S./Canada
    • Tanta, Outside U.S./Canada, Egypt, 6620010
      • Recruiting
      • Urolgy Departement, Faculty of Medicine, Tanta University
      • Contact: Ahmed G. Zoeir, Ph D; Phone Number: +2 +201008634198; Email: drahmedzoeir27@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• adult patients with enlarged prostate presenting with LUTS or urine retention

Exclusion Criteria:

• Unfit patients
• Renal impairment
• active UTI
• urethral strictures

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Garamicin group; the participants in this arm will undergo TURP with addition of one ampoule of gentamicin 80 mg (2ml) /3L of irrigation solution (the first 9 Liters during resection and the first 6 Liters during post-operative irrigation)	Procedure: Transurethral resection of the prostate (TURP); TURP with addition of gentamicin on irrigation fluid to reduce infectious complications; Drug: Gentamicin; gentamicin 80 mg (2ml) /3L of irrigation solution (the first 9 Liters during resection and the first 6 Liters during post-operative irrigation)
Placebo Comparator: control group; the participants in this arm will undergo TURP with addition of normal saline (2 ml) on the irrigation solution (placebo).	Procedure: Transurethral resection of the prostate (TURP); TURP with addition of gentamicin on irrigation fluid to reduce infectious complications; Drug: normal saline; normal saline (2 ml) on the irrigation solution (placebo)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
infectious complications	Post-TURP pyuria and bacteruria	1 week and 1 month after removal of urethral catheter

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Estimated): December 7, 2023
• Primary Completion (Estimated): June 7, 2024
• Study Completion (Estimated): July 7, 2024

Study Registration Dates

• First Submitted: December 5, 2023
• First Submitted That Met QC Criteria: December 12, 2023
• First Posted (Estimated): December 13, 2023

Study Record Updates

• Last Update Posted (Estimated): December 13, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Gentamicins
• Other Study ID Numbers: 35121/12/21

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No