Femistina versus Canephron as a prevention of urinary tract infections after midurethral sling surgery - Non-inferiority study.
Eur J Obstet Gynecol Reprod Biol
; 277: 71-76, 2022 Oct.
Article
en En
| MEDLINE
| ID: mdl-36027670
ABSTRACT
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. STUDYDESIGN:
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 11 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.Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Incontinencia Urinaria de Esfuerzo
/
Infecciones Urinarias
/
Cabestrillo Suburetral
Tipo de estudio:
Clinical_trials
/
Etiology_studies
Límite:
Female
/
Humans
Idioma:
En
Revista:
Eur J Obstet Gynecol Reprod Biol
Año:
2022
Tipo del documento:
Article
País de afiliación:
Polonia