Efficacy Study of Methenamine + Methylthioninium Chloride vs Phenazopyridine for the Symptomatic Control of Dysuria
Efficacy Study of Methenamine + Methylthioninium Chloride vs Phenazopyridine for the Symptomatic Control of Dysuria
The purpose of this study is to evaluate the efficacy of the combination of Methenamine +
 Methylthioninium chloride compared to phenazopyridine (comparator product) in the symptomatic
 relief of dysuria.
-  Single blind, randomized, prospective study.

 -  Length of experience: 03 days to 07 days.

 -  03 visits (days 1, 4 and 7).

 -  Evaluation of the efficacy and safety of the medication.

 -  Shall be assessed for adverse events.
Inclusion Criteria:

 -  Patients who agree to participate by agreeing to the terms proposed in the Clinical
 trial;

 -  Patients aged over 18 years of any ethnicity;

 -  Presence of dysuria with marking greater than or equal to 5 measured points on the
 categorical scale pre-treatment for pain symptom;

 Exclusion Criteria:

 -  Patients who are febrile (axillary T º: ≥ 38 ° C), with back pain or lumbar;

 -  Patients with complicated clinical presentation of urinary tract infection;

 -  Patients with a history of allergy or intolerance to any known or suspected one of the
 ingredients of the product under investigation;

 -  Patients who are pregnant or during lactation, or childbearing potential and are not
 making use of effective contraception;

 -  Patients presenting with renal disease or severe liver disease, according to medical
 history and / or laboratory;

 -  Patients presenting with severe systemic disease according to the known medical
 history;

 -  Patients who received antibiotic treatment, anthelmintic within 7 days prior to study
 entry;

 -  Patients unable to understand the guidelines specified in this protocol or can not
 attend all study visits or unable to complete the log;

 -  Pregnancy or risk of pregnancy and lactating patients;

 -  Any finding of clinical observation (history and physical examination) that is
 interpreted by the physician investigator as a risk to the patient's participation in
 the study.