Non Interventional Study of Levofloxacin in Chronic Prostatitis

Study Overview
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Brief Summary
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Chronic prostatitis is a common disease in men with the following typical symptoms decreasing the ability to work and quality of life: pain, urination disorders, copulatory dysfunction. Following study is conducted to study Levofloxacin in chronic prostatitis.

Detailed Description
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Chronic prostatitis is a common disease in men with the following typical symptoms decreasing the ability to work and quality of life: pain, urination disorders, copulatory dysfunction. Professional societies recommend diagnosing and treating patients with chronic prostatitis on the basis of determination of belonging to classification categories proposed by the National Institute of Diabetes and Digestive and Kidney Diseases and the National Institutes of Health in the USA . According to the recommendations of European Association of Urologists, in chronic bacterial inflammation of the prostate and in nonbacterial (inflammatory syndrome of chronic pelvis pain), the performance of antibacterial therapy during four - six weeks is efficient. The first-line drugs are fluoroquinolones (ciprofloxacin and levofloxacin) as along with good tolerance they easily penetrate into the zones of the prostate inflammation and are highly efficient in respect of prostatitis pathogens . Although the treatment with levofloxacin promotes more evident decrease in clinical symptoms and demonstrates better parameters of eradication of pathogen in comparison with ciprofloxacin administration, it is used less common, possibly due to insufficient awareness of physicians of its high efficacy in chronic prostatitis .

Official Title
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Non-interventional (Observational) Study of the Administration of Levolet® R, Film-coated Tablets (Dr. Reddy's Laboratories Ltd., India) in Adults With Chronic Prostatitis in Routine Clinical Practice

Conditions
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Chronic Prostatitis

Intervention / Treatment
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* Drug: Levofloxacin 500


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male patients aged from 18 to 60 years, inclusive, with a diagnosis of the chronic prostatitis, which appointed the drug Levolet® P as a causal treatment. Demonstrated sensitivity to levofloxacin abjection of chronic bacterial prostatitis. The presence of a written informed consent to participate in research Exclusion Criteria: participation in another clinical study during the period of this study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

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

| Intervention/Treatment |
| --- |
|Drug: Levofloxacin 500|Oral levofloxacin (Levolet®) at a dose of 500 mg once a day for 28 days|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with response as per IMPSS scale | Subjective evaluation of the treatment was performed using Integrative Medicine Patient Satisfaction Scale - IMPSS: completely satisfied, satisfied, neutral attitude, unsatisfied and extremely unsatisfied. | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients response as per IMOS | Therapy results were evaluated using physician's opinion according to Integrative Medicine Outcome Scale - IMOS (complete recovery, significant improvement, insignificant to moderate improvement, no changes, deterioration) | 28 days |