Phase
Condition
Urinary Tract Infections
Urinary Incontinence
Bladder Disorders
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Sign, initialize and date the informed consent form
Age ≥ 18 years
For urinary infection diagnosis, the following parameters must be considered in theurine I test:
Leukocyturia: ≥ 15,000 leukocytes
Epidermal cells: < 20,000/mL
Presence of bacteriuria
Presence of nitrite (positive results)
To have a 2 points score (from 12 points) regarding the following symptoms of acutecystitis:
Dysuria
Urinary urgency
Frequent urination
Pain in the upper area of pubis Each symptom must be scored according to the classification below. Total score may rangefrom 0 to 12 points. Severity Value Absent 0 Mild 1 Moderate 2 Severe 3
Exclusion
Exclusion Criteria: Research subjects that meet any of the criteria below will not be eligible for the study:
Asymptomatic urinary infection or infection in any organ
Documented incidence of UTI in the last year
Symptoms of pyelonephritis (cystitis symptoms plus fever, lower back pain or chills)
History of complicated urinary tract infection (congenital abnormalities, urinarytract distortion or obstruction, formation of calculus in the urinary tract)
Use of catheter in the urinary tract
Chronic renal or hepatic disease
Seizure-related diseases
Neurological deficits that interfere in the urinary flow and tract defense
Decompensated diabetes mellitus (fasting blood glucose ≥ 150 mg/dL);
Immunodepression:
Subjects with the human immunodeficiency virus (HIV)
Chronic use of corticosteroids in a dose ≥ 5 mg/day of prednisone for over 30 days
Any diseases related to immune dysfunction
Severe comorbidities (at the investigator's discretion)
History of allergy to penicillins, cephalosporines or quinolones
Subjects on medications such as antibiotics, amiodarone, antacids or sucralphate,tricyclic antidepressants, antipsychotics, cyclosporine, cisapride, didanosine,erythromycin, fembufeno, gliburide (a sulphonilurea), nitrofurantoin, probenecid,procainamide, quinidine, sotalol, teophylline, warfarin
Treatment due to UTI two weeks before entering study, or on antimicrobial treatment atleast 3 times within the last 12 months
Use of phenazopyridine 7 days before entering the study
Hospitalization 30 days before study enrollment
Female research subjects that are pregnant, breastfeeding, or women with childbearingpotential that deny to use at least two safe contraceptive methods during study
Participation in another clinical trial in the last 12 months