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.

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06168708

Enrollment

220

Registered

2023-12-13

Start date

2023-12-07

Completion date

2024-07-07

Last updated

2023-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-TURP Infectious Complications

Brief summary

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

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.

Interventions

PROCEDURETransurethral resection of the prostate (TURP)

TURP with addition of gentamicin on irrigation fluid to reduce infectious complications

DRUGGentamicin

gentamicin 80 mg (2ml) /3L of irrigation solution (the first 9 Liters during resection and the first 6 Liters during post-operative irrigation)

DRUGnormal saline

normal saline (2 ml) on the irrigation solution (placebo)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

MALE

Age

45 Years to 80 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Countries

Egypt

Contacts

Primary ContactAhmed G. Zoeir, Ph D

drahmedzoeir27@gmail.com+201008634198

Backup ContactAhmed A. Eissa, Ph D

ahmed.taha.eissa@gmail.com01110304666

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026