Skip to content

Antibiotic prophylaxis for patients with asymptomatic urinary tract infection undergoing urodynamic study: a randomized-controlled trial

Antibiotic prophylaxis for patients with asymptomatic urinary tract infection undergoing urodynamic study: a randomized-controlled trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20200408003
Enrollment
120
Registered
2020-04-08
Start date
2020-06-15
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Patients with asymptomatic urinary tract infection undergoing urodynamic study in Srinagarind hospital Antibiotic prophylaxis Asymptomatic urinary tract infection Urodynamic study

Interventions

Patients that were assigned to the antibiotic prophylaxis group received a 30-minute intravenous (IV) infusion of gentamicin 5 mg/kg and a 1-hour IV infusion of ampicillin within 1 hour before UDS if
Experimental Drug,No Intervention No treatment
Antibiotic prophylaxis before urodynamic study,without antibiotic prophylaxis before urodynamic study

Sponsors

Faculty of Medicine Research Grant Khon Kaen University
Lead Sponsor
Research Affairs, Faculty of Medicine, Khon Kean University
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged over 18 years 2. Patients were admitted for the urodynamic examination 3. no signs and symptoms of UTI, defined according to at least one of the following - fever (temperature over 37.8-Celsius degree) with no other apparent causes - onset of dysuria, urgency, frequency - suprapubic or flank pain - increased spasticity - autonomic dysreflexia - malaise, lethargy, or sense of unease 4. Evidence of pyuria - urine WBC over 10 cells/HPF or -positive urine leukocyte esterase 5. Evidence of significant bacteriuria -bacteria count from urine culture more than 10000 CFU/mL from non-catheter specimens or more than 100 CFU/mL from catheter specimens or positive urine nitrite 6. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Pregnancy and breastfeeding 2. Received any antibiotics 7 days prior to enrollment 3. Known allergy or contraindicated for penicillin, ceftriaxone, or gentamicin 4. Immunocompromised state defined as received immunosuppressive agents, prednisolone more than 15 mg/day or equivalent dose, chemotherapy session in the past 1 month, neutropenia (WBC less than 1000 cells/mm3) 5. Liver cirrhosis child B or C 6. History of urinary stones or bladder outlet obstruction 7. History of urosepsis post-UDS

Design outcomes

Primary

MeasureTime frame
An incidence rate of symptomatic UTI assessed within 48 hours after UDS 1 week Assess clinical signs and symptoms of symptomatic UTI combine with urinalysis examination and urine culture within 48 hours after UDS

Secondary

MeasureTime frame
Adverse effects and microbiology clearance of urine at 48 hours after UDS 48 hours Assess clinical adverse effect of antibiotic by questionnaire and performed urine culture at 48 hours after UDS

Countries

Thailand

Contacts

Public ContactSiriluck Anunnatsiri

Faculty of Medicine, Khon Kaen University

asiril@kku.ac.th66846846998

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026