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Comparing one day of intravenous Amikacin to 3 days in preventing urinary infection in patients undergoing transurethral resection of the Prostate

Prospective, Randomized, Comparative Study on the Efficacy of one day versus 3 days of intravenous Amikacin(15mg/Kg) as prophylaxis in patients undergoing transurethral resection of the Prostate

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/09/009721
Enrollment
334
Registered
2017-09-12
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Bladder outlet obstruction due to benign prostatic enlargement Health Condition 2: N390- Urinary tract infection, site notspecified

Interventions

Intervention1: Inj. AMIKACIN as prophylaxis IN URINE CULTURE NEGATIVE PATIENTS UNDERGOING TURP: Inj.Amikacin 15 mg/Kg as prophylaxis in patients undergoing TURP Control Intervention1: 1 day versus 3 d

Sponsors

Fluid research fund CMC Vellore
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients undergoing TURP who have sterile preoperative urine culture (patients without bacteriuria preoperatively - cfu < 104/ml)

Exclusion criteria

Exclusion criteria: 1.Patients on a catheter(SPC/perurethral) 2.Preoperative urine culture positivity. 3.Patients who have received antibiotics in the past 1 week. 4.Any contraindication to aminoglycoside 5. Patients who require prolonged catheterization or who develop AUR(acute urinary retention) and need re-catheterisation/ Bladder wash and Re-operation due to hematuria.

Design outcomes

Primary

MeasureTime frame
To assess the rate of bacteriuria (CFU 104/ml) 4 days after TUR-PTimepoint: 4 days after TUR-P—

Secondary

MeasureTime frame
a. Incidence of postoperative symptomatic UTI and other complications. b. To assess the risk factors for developing complications UTI, Sepsis, Hemorrhage Timepoint: At 1 week and 4 weeks follow up—

Countries

India

Contacts

Public ContactSelvin Theodore Jayanth E

Christian Medical College, Vellore

chandrasingh@cmcvellore.ac.in9442609368

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 4, 2026