Role Prophylactic nitrofurantoin in preventing urinary infection after routine cystocopy
Not Applicable
- Conditions
- Health Condition 1: N390- Urinary tract infection, site notspecified
- Registration Number
- CTRI/2019/11/022022
- Lead Sponsor
- niversity College of Medical Sciences University of Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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