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

Phase 3

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

• Registration Number: TCTR20200408003
• Lead Sponsor: Faculty of Medicine Research Grant Khon Kaen University

Brief Summary

The incidence rate of symptomatic UTI after UDS was significantly higher in patients with no antibiotic prophylaxis (5/13; 38.5%) than those who received antibiotic prophylaxis (0%) (P-value 0.04). The microbiological clearance in the urine at 48 hours after UDS was significantly higher in patients who received an antibiotic prophylaxis (8/11; 72.7%) compared to those without an antibiotic prophylaxis (0/13; 0%) (P-value less than 0.001).

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-08
• Study Completion: 2021-02-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Terminated (Halted Prematurely)
• Sex: All
• Target Recruitment: 26

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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