Assessment of UTI Symptoms and Quality of Life According to Antibiotics Treatment in Acute Uncomplicated Cystitis

Study Overview
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Brief Summary
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Although Cystitis includes a clinical syndrome characterized by various combinations of dysuria (painful urination), frequency, urgency, gross haematuria, lower back and/or abdominal/suprapubic discomfort with pyuria and bacteriuria. An acute uncomplicated UTI (referred to as cystitis) has been focused microorganisms and drug-resistance. There has been little research on Clinical aspects on cystitis treatment such as bothersomeness, or the impact of symptoms on patients' quality of life (QoL). The investigators want to study for Assessment of UTI Symptoms and Quality of Life According to Antibiotics Treatment(Ciprobay) in Acute Uncomplicated Cystitis in Korean Women.

Official Title
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A Study of Quality of Life and Changes to Symptom Relief for Acute Uncomplicated Cystitis Treated With Antibiotics (Ciprobay); Prospective, Open-label, Multicenter, Observational Study

Conditions
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Acute Cystitis

Intervention / Treatment
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* Drug: Ciprobay


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female outpatients (20-65 years old) Acute cystitis symptoms (subject-reported) for < 1 week prior to Visit 1. Exclusion Criteria: Acute cystitis symptoms for ≥ 1 week prior to Visit 1. Diabetes mellitus Congenital urinary tract abnormality Female subjects who are pregnant, nursing, or with a positive urine pregnancy test or who are intending to become pregnant during the study or within 3 months after the completion of the study. Hypersensitivity to the active substance (Ciprobay). Subjects who have vaginal discharge Fever ( ≥ 37.5 ºC) Sexually transmitted diseases. Documented significant renal disease (sCr > 1.5) Subjects who cannot consent to this study. Subjects who had received antimicrobial agents in the previous 4 weeks. Recurrent urinary tract infection defined as treatment for UTI > 3 times in the last year. Use of an indwelling catheter or an intermittent self-catheterization program. Neurogenic bladder.

Ages Eligible for Study
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Minimum Age: 20 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cystitis<br>female with cystitis symptoms | Drug: Ciprobay<br>* Ciprobay (250mg, bid, oral)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect on patient satisfaction and quality of life. |  | at day 5 relative to baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in UTISA sub-category (dysuria, frequency, urgency, pain, hematuria) |  | at day 10, 21 and 28 relative to baseline | 
| Change in KHQ |  | at day 10, 21 and 28 relative to baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute cystitis, Antibiotics, Quality of life