Treatment and/or Prevention of Urinary Tract Infections
Treatment and/or Prevention of Urinary Tract Infections
The purpose of the study is to determine the effect of an investigational oral rinse in
 reducing uropathogens and treating uncomplicated urinary tract infections.
A 7-day treatment with a 28-day follow up has been designed as a "before and after"
 assessment of the clinical signs and symptoms of an uncomplicated urinary tract infection and
 the reduction/eradication of urinary pathogens. Enrollment is targeted to achieving 20
 evaluable subjects by the end of the study. After enrolling in the trial at Day 0 (first day
 of dosing), participants will report back to the study site at Days 3, 7, and 28. At Day 3 or
 any time thereafter, worsening of symptoms and/or increases in quantitative bacteria counts
 will result in removal from the trial and prescription of a rescue medication, which will be
 selected based on microbial susceptibility testing.
Inclusion Criteria:

 1. Non-pregnant adult females;

 2. 18 years of age or older;

 3. Clinical signs with one or more symptoms of a UTI (e.g., dysuria, frequency, urgency,
 suprapubic pain) with onset of symptoms < 72 hours prior to study entry;

 4. One positive dipstick urine test positive either for leukocyte esterase or nitrates or
 have a urinalysis with > 5 wbc/hpf.

 5. A pre-treatment clean-catch midstream urine culture with ≥ 104 CFU/mL of a bacterial
 organism

 Exclusion Criteria:

 1. Males;

 2. Women who are pregnant, nursing, or not using a medically accepted, effective method
 of birth control;

 3. Three or more episodes of acute uncomplicated UTI in the past 12 months;

 4. Known structural abnormality that would predispose the participant to reflux or
 urinary retention;

 5. Patients with evidence of factors predisposing to the development of urinary tract
 infections, including calculi, stricture, primary renal disease (e.g., polycystic
 renal disease), or neurogenic bladder;

 6. Patients with significant impaired immunity secondary to chemotherapy, oral
 corticosteroids, or HIV;

 7. Patients with onset of symptoms > 72 hours prior to entry;

 8. Patients with a temperature ≥ 100°F, flank pain, chills, or any other manifestations
 suggestive of upper urinary tract infection;

 9. Patients with purported hypersensitivity to iodine;

 10. Patients with history of thyroid disease;

 11. Patients who received treatment with other antimicrobials within 48 hours prior to
 entry;

 12. Any significant medical or psychiatric condition that would render examination
 difficult or invalid or prevent the subject from active study participation; inability
 to use an oral rinse;

 13. Use of concomitant medication that, in the opinion of the Study Directors, might
 interfere with the outcome of the study.