Using gentamicin in irrigation fluid to prevent infections after prostate surgery
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.
NA · Tanta University · NCT06168708
This study is testing if adding gentamicin to the fluid used during prostate surgery can help prevent infections in patients after the procedure.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 220 (estimated) |
| Ages | 45 Years to 80 Years |
| Sex | Male |
| Sponsor | Tanta University (other) |
| Locations | 1 site (Tanta, Outside U.S./Canada) |
| Trial ID | NCT06168708 on ClinicalTrials.gov |
What this trial studies
This clinical study evaluates the safety and efficacy of adding gentamicin to irrigation fluid during trans-urethral resection of the prostate (TURP) to reduce post-operative infectious complications. A total of 220 patients scheduled for TURP will be randomly assigned to receive either gentamicin or a placebo in their irrigation solution. The study will assess outcomes such as post-operative pyuria, bacteriuria, fever, and sepsis one week after catheter removal. The goal is to determine if gentamicin can effectively lower the risk of infections following the procedure.
Who should consider this trial
Good fit: Ideal candidates are adult patients with enlarged prostates presenting with lower urinary tract symptoms (LUTS) or urinary retention.
Not a fit: Patients who are unfit, have renal impairment, active urinary tract infections, or urethral strictures may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of post-operative infections in patients undergoing TURP.
How similar studies have performed: While the use of antibiotics in irrigation fluids is a common practice, this specific approach with gentamicin has not been extensively tested, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * adult patients with enlarged prostate presenting with LUTS or urine retention Exclusion Criteria: * Unfit patients * Renal impairment * active UTI * urethral strictures
Where this trial is running
Tanta, Outside U.S./Canada
- Urolgy Departement, Faculty of Medicine, Tanta University — Tanta, Outside U.S./Canada, Egypt (RECRUITING)
Study contacts
- Study coordinator: Ahmed G. Zoeir, Ph D
- Email: drahmedzoeir27@gmail.com
- Phone: +201008634198
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Post-TURP Infectious Complications