Utipro® is more effective than placebo in reducing recurrent cystitis. Preliminary results.
==inizio abstract==
Introduction
Recurrence will occur in 20-30% of patients presenting acute cystitis.
Utipro® is a new Medical Device approved for the control and prevention of urinary tract infections. The product contains a gelatine stabilized complex, hibiscus sabdariffa and propolis.
Objective: to evaluate whether Utipro® is more effective than placebo in improving symptoms and reducing the risk of recurrence in patients presenting acute cystitis.
Material and methods
Prospective, randomized, double-blind controlled trial.
Inclusion criteria: ≥18 years, symptoms of cystitis, ciprofloxacin-sensitive uropathogens in a urine culture.
Exclusion criteria: temperature≥37.5ºC, pregnancy, lactation, major illnesses (haematological, renal, cardiac, pulmonary and/or hepatic).
Measuraments: dysuria, number of daily urinations, urine culture and adverse effects. 6 months follow-up.
Intervention: oral daily ciprofloxacin 500 mg for 5 days with Utipro® or placebo administrated for two times, followed by fifteen days with administration once daily. Other cycles of once daily Utipro® or placebo capsule for 15 days were administrated after 1 and 2 months.
Results (placebo vs Utipro®)
No adverse affects were recorded.
Num. patients
– Month 1: 50, 50
– Month 2: 46, 48
– Month 3: 36, 43
– Month 6: 14, 17
Num. daily urinations (a)
– Month 1: 6,18 (1,14), 5,64 (1,03). p<0,05(b)
– Month 2: 5,96 (0,92), 5,50 (0,72). p0,05(b)
Dysuria
– Month 1: 15, 11.p=0,495(c)
– Month 2: 7, 1. p=0,029(c)
– Month 3: 4, 0. p=0,039(d)
– Month 6: 2,0. p=0,196(d)
Urine culture +
– Month 1: 11, 6. p=0,285(c)
– Month 2: 3, 0. p=0,113(d)
– Month 3: 4, 0. p=0,039(d)
– Month 6: 5, 0. p=0,012(d)
(a) Mean, std. deviation in brackets, (b) Student t test
(c) chi-square test, (d) Fisher’s exact test
Conclusions
Utipro® was superior to placebo in reducing recurrent cystitis at 3 months, with encouraging preliminary results at 6 months.
==fine abstract==
Commenti recenti