European journal of obstetrics, gynecology, and reproductive biology · 2022
Femistina versus Canephron as a prevention of urinary tract infections after midurethral sling surgery - Non-inferiority study.
СтатьяРандомизированное исследованиеEquivalence TrialНазвание и аннотация: Перевод в очереди
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Rechberger Ewa, Wróbel Andrzej, Kulik-Rechberger Beata, Miotła Paweł, Rechberger Tomasz
Аннотация
OBJECTIVE: Urinary tract infection (UTI) is relatively common post-operative complication following midurethral sling placement (MUS), even in cases where intraoperative antibiotic prophylaxis was given. The primary aim of this study was to investigate the non-inferiority of Femistina as compared with Canephron in reducing symptomatic UTI in first six months following surgery.
STUDY DESIGN: A sample size of 144 patients per group was established, to provide at least 90% power to demonstrate the non-inferiority of phytodrug Femistina versus Canephron as a prevention of post-MUS urinary tract infection.
RESULTS: Women suffering from stress urinary incontinence and mixed urinary incontinence (MUI) with predominant SUI symptoms as confirmed by urodymamics (n = 320) were randomized in a 1:1 ratio to Femistina (40 mg, oral, twice daily for 20 days) or Canephron (3 × 5 ml taken orally-three times daily for 4 weeks). Both groups were homogenous for age, type of operation (only TOT outside-in) and severity of illness as indicated by ICIQ-SF questionnaire. We found that symptoms of UTI were significantly lower in patients receiving Femistina. During first 6 months after surgery UTI was confirmed in only 10 patients receiving Femistina (6,25%) when compared to 25 (15,63%) subjects receiving Canephron, p < 0.007.
CONCLUSION: Femistina is not inferior to Canephron in preventing lower urinary tract infection after midurethral sling surgery.
STUDY DESIGN: A sample size of 144 patients per group was established, to provide at least 90% power to demonstrate the non-inferiority of phytodrug Femistina versus Canephron as a prevention of post-MUS urinary tract infection.
RESULTS: Women suffering from stress urinary incontinence and mixed urinary incontinence (MUI) with predominant SUI symptoms as confirmed by urodymamics (n = 320) were randomized in a 1:1 ratio to Femistina (40 mg, oral, twice daily for 20 days) or Canephron (3 × 5 ml taken orally-three times daily for 4 weeks). Both groups were homogenous for age, type of operation (only TOT outside-in) and severity of illness as indicated by ICIQ-SF questionnaire. We found that symptoms of UTI were significantly lower in patients receiving Femistina. During first 6 months after surgery UTI was confirmed in only 10 patients receiving Femistina (6,25%) when compared to 25 (15,63%) subjects receiving Canephron, p < 0.007.
CONCLUSION: Femistina is not inferior to Canephron in preventing lower urinary tract infection after midurethral sling surgery.