A Phase IV Study of Cipro XR in Uncomplicated UTI

Study Overview
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Brief Summary
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Safety and efficacy of Cipro XR in a naturalistic setting and the effectiveness of an educational brochure. - Women with urinary tract infections were treated with Cipro XR. They were also given a brochure with information about urinary tract infections and later tested on the information.

Official Title
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EXPRESS: Evaluating Cipro XR Patient Response, Education, Safety, and Satisfaction

Conditions
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Urinary Tract Infections

Intervention / Treatment
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* Behavioral: Cipro XR (Ciprofloxacin, BAYQ3939)
* Behavioral: Cipro XR (Ciprofloxacin, BAYQ3939)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ambulatory women outpatients 18 to 65 years of age with a documented clinical diagnosis of uUTI characterized by dysuria with either urgency or frequency. Women of childbearing age were enrolled only if they were highly unlikely to conceive during the study and were practicing a suitable method of birth control or were at least 1 year postmenopausal. Positive leukocyte esterase (>/= 1+) and positive nitrite test using a urine dipstick method of analysis. Willing to give written consent. Exclusion Criteria: Pregnant or nursing Complicated UTI Allergy to Cipro XR

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Behavioral: Cipro XR (Ciprofloxacin, BAYQ3939)<br>* Received Cipro XR (Ciprofloxacin, BAYQ3939) 500 mg once daily for 3 days and brochure about UTI<br>|
| Experimental: Arm 2<br> | Behavioral: Cipro XR (Ciprofloxacin, BAYQ3939)<br>* Received Cipro XR (Ciprofloxacin, BAYQ3939) 500 mg once daily for 3 days; not given brochure about UTI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the effect on knowledge of uncomplicated urinary tract infection (uUTI) in patients who were given a disease-directed educational brochure to read versus patients who were not given the brochure. |  | 3-10 days after start of therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To examine the difference between physician and patient perceptions of the symptoms of uUTI. |  | At baseline visit pre-therapy | 
| To collect data on the clinical efficacy and safety of Cipro XR, 500 mg, PO once daily, for 3 days, in the treatment of uUTI in a naturalistic setting. |  | 1-3 days after end of therapy for efficacy and up to 30 days for safety | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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UTI