Clinical study of effectiveness and safety of CELcomplex ((R)) containing Cucurbita Pepo Seed extract and Flax and Casuarina on stress urinary incontinence in women

作者: Andrea Gazová , Simona Valaskova , Viera Zufková , Ana M Castejon , Ján Kyselovic

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摘要: Aim: The safety and effectiveness of a preparation containing a mix of Cucurbita Pepo Seed extract, Equisetum arvense and Linum usitatissimum-Flax A (CELcomplex®) on stress urinary incontinence (SUI) was evaluated in female patients recruited from 20 urological and gynaecological outpatient clinics in Slovakia.Methods: A total of 86 women aged from 32 to 88 with SUI (grade 1= 44, grade 2= 42) were enrolled in the study and followed-up for six weeks (point 1) and twelve weeks (point 2). The primary outcome of the study was evaluated by changes in day-time and nocturnal urinary frequency (bathroom visits) and urinary incontinence episodes (leaks). Also, adverse events were quantified as well as the self-perceived effectiveness of the treatment. Research Ethics Board approval was obtained for this study. Results: After 12 weeks of treatment there was a 30%(grade 1 SUI, p< 0.01), and 35%(grade 2 SUI, p< 0.01) improvement in urinary incontinence episodes, a 40%(grade 1 SUI, p< 0.01) and 26%(grade 2 SUI, p< 0.01) improvement in day-time urination frequency and 64%(grade 1 SUI, p< 0.01) and 54%(grade 2 SUI, p< 0.01) improvement in nocturnal urinary frequency. Reported side effects were: headache (3.5%), flatulence (4.1%) and gastrointestinal discomfort (3%). A total of 89.4% of women in the study reported no side effects from this therapy and 97% acknowledged improvement of symptoms. Conclusion: This clinical study demonstrated that a 12 week treatment with a mix of Cucurbita Pepo Seed extract, Equisetum arvense and Linum usitatissimum-Flax A (CELcomplex®) is highly effective on stress urinary incontinence (SUI …

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