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Akush Ginekol (Sofiia) · Jan 2012
Multicenter Study Comparative Study Clinical Trial[A multicenter comparative observation on the effectiveness and the rapidness of the effect of Cystostop Rapid versus antibiotic therapy in patients with uncomplicated cystitis].
- P Panchev, Ch Slavov, D Mladenov, M Georgiev, K Yanev, E Paskalev, P Simeonov, R Gerassi, B Bogov, and I Saltirov.
- Akush Ginekol (Sofiia). 2012 Jan 1; 51 (7): 49-55.
UnlabelledThe currently available treatment for uncomplicated urinary tract infections includes only antibiotics and chemotherapeutic agents. Experience in the management of acute uncomplicated infections using non-antibiotic products is very limited. The aim of this observation was to study to what extent the response to Cystostop Rapid would be more rapid and more effective compared to antibiotic therapy in patients with acute uncomplicated urinary bladder infections. The secondary objective was to determine the time to improvement of cystitis symptoms following the start of treatment, as well as the duration of patients' disablement. A total of 158 female subjects were included, assessed microbiologically, and evaluated for incidence and severity of symptoms, before the start of treatment and after completion of treatment. A visual analogue scale was used for patient self-assessment of the severity of symptoms, the improvement of symptoms, as well as the time to improvement of symptoms.Results158 females, eligible according to the inclusion criteria of the study, were allocated to one of the two groups according to time of enrollment: Group A included 86 subjects: assigned to Cystostop Rapid for 3 days and administered according to the manufacturer's recommended regimen; and Group B included 72 women: assigned to ciprofloxacin 500 mg twice daily for 3 days according to the Product Registration File with the BDA. The clinical and microbiological effectiveness of Cystostop Rapid was comparable to that of ciprofloxacin, providing a two-fold more rapid improvement of cystitis symptoms, at a mean time to improvement of 24 hours (p < 0.02) versus 46 hours for ciprofloxacin. Clinical improvement within 48 hours of Cystostop Rapid regimen occurred in 97% (p < 0.02) of patients, vs. 65.3% of patients on ciprofloxacin. Improvement of symptoms within 12 hours was reported in 36% of patients on Cystostop Rapid vs. 5.5% of patients in the ciprofloxacin group (p < 0.02). No adverse events or intolerability to the therapy were reported throughout the course of the study.
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