Health Condition 1: N390- Urinary tract infection, site notspecified
Conditions
Interventions
Intervention1: NFT Test: Tab/Cap Nitrofurantoin 100 mg stat single oral dose) 2 hours prior to procedure
Control Intervention1: Control Cap: One placebo (empty capsule) stat single dose 2 hours prior
Sponsors
University College of Medical Sciences University of Delhi
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients undergoing routine office rigid cystoscopy of age between 18-80yrs. 2.Patients undergoing cystoscopy for ureteral JJ stent removal.
Exclusion criteria
Exclusion criteria: 1.Patients with symptoms of active/untreated UTI. 2.Patients showing growth in urine culture done prior to cystoscopy. 3.High risk patients-DM,Immunosuppressed,CKD etc, 4.Patients with indwelling urethral catheters/ stricture urethra undergoing manipulation/ OIU. 5.Patients with hypersensitivity and or any contraindications to nitrofurantoin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy Criteria: (i) Urine c/s positive at 48hrs,7d, 2wks (primary endpoint) i.e. Urine culture of 100,000 CFU/mL urine. (Objective) & (ii) S/s and positive LET of UTI (Subjective) at 48hrs/7days/2weeks. The primary outcome will be development of urinary tract infection (UTI) within 2 weeks after cystoscopy.Timepoint: 48 hrs, 7d, 14d | — |
Secondary
| Measure | Time frame |
|---|---|
| Criteria for safety will be (i) by monitoring TEAE of NFT as per performa (ADE, ADR, SE, SAE). Criteria for Morbidity will be (i) VAS pain score at 1hour post CPE and (ii) Clavein Dindo grade of complications including symptomatic gross hematuria within 24 hrs.Timepoint: 1hrs, 24hrs, 48hrs, 7d, 14d | — |
Countries
India
Contacts
Public ContactDr Monirah Zeya
University College of Medical Sciences University of Delhi GTBH
Outcome results
None listed