Clinical Trial: Non Interventional Study of Levofloxacin in Chronic Prostatitis

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

Brief Summary:

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 Summary:

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 .


Sponsor: Dr. Reddy's Laboratories Limited

Current Primary Outcome: Percentage of patients with response as per IMPSS scale [ Time Frame: 28 days ]

Subjective evaluation of the treatment was performed using Integrative Medicine Patient Satisfaction Scale - IMPSS: completely satisfied, satisfied, neutral attitude, unsatisfied and extremely unsatisfied.


Original Primary Outcome: Same as current

Current Secondary Outcome: Percentage of patients response as per IMOS [ Time Frame: 28 days ]

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)


Original Secondary Outcome: Same as current

Information By: Dr. Reddy's Laboratories Limited

Dates:
Date Received: March 14, 2016
Date Started: July 2013
Date Completion:
Last Updated: March 16, 2016
Last Verified: March 2016