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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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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.

Conditions
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Post-TURP Infectious Complications

Intervention / Treatment
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* Procedure: Transurethral resection of the prostate (TURP)
* Drug: Gentamicin
* Drug: normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult patients with enlarged prostate presenting with LUTS or urine retention Exclusion Criteria: Unfit patients Renal impairment active UTI urethral strictures

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Garamicin group<br>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)<br>* TURP with addition of gentamicin on irrigation fluid to reduce infectious complications<br>Drug: Gentamicin<br>* gentamicin 80 mg (2ml) /3L of irrigation solution (the first 9 Liters during resection and the first 6 Liters during post-operative irrigation)<br>|
| Placebo Comparator: control group<br>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)<br>* TURP with addition of gentamicin on irrigation fluid to reduce infectious complications<br>Drug: normal saline<br>* normal saline (2 ml) on the irrigation solution (placebo)<br>|

What is the study measuring?
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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 |