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Effects of EFLA®940 / Soybean Germ Extract combination on stress urinary incontinence in an open clinical study

• EFLA®940 Pumpkin seed extract – Cucurbitae Sem extr.s.sicc
• SoyLife – Soy germ extract

Study Summary

To investigate the efficacy and safety of a health food product containing EFLA®940 and soybean germ extract in the treatment of urinary incontinence, an open clinical study was conducted in Japan on pre- and postmenopausal women suffering from stress urinary incontinence.

Study design

Subjects: 50 women (aged 35-84) suffering from stress incontinence. The study was performed on two study sites.
Study duration: 6 weeks. Daily dosage: 875 mg EFLA®940 and 164mg soybean germ extract (30% soy isoflavones) during weeks 1-2, 525 mg respectively 100 mg during the following weeks.
Participants were asked to record incontinence episodes and subjective degree of satisfaction daily. Efficacy was rated as one of four grades by the investigator.
Statistical significance was determined by comparison of the mean before (initial) and after dosing using paired t-test. Laboratory tests and recorded vital signs and adverse events were analysed for safety and tolerance assessment.

Results

Incontinence Episodes
The frequency of urination incontinence per day already markedly improved at week 2 of treatment, with a further decrease after 6 weeks of treatment.

Effects of EFLA®940 / Soybean Germ Extract combination on pollakiuria in elderly men

Dividing the subjects into groups, based on the frequency of incontinence before treatment, resulted in a significant decrease in incontinence in the group of patients showing the highest initial number of incontinence episodes.

Total Rate of Improvement

EFLA®940/soybean germ extract combination also improved the quality of life, as concluded from the participants’ subjective judgment. All of the favorable effects described above were reflected by a high general improvement rate, as confirmed by the overall efficacy judged by the investigator based on all data. From a total improvement rate of 87.5% after two weeks of treatment, 10.4% of the patients were graded «Markedly improved». After six weeks of treatment the percentage of this “Markedly improved» group even increased to 27.1% whereas the total improvement rate stayed at 87.5%.

Safety

The study product showed high compliance and demonstrated high safety and tolerance.

Conclusion

The present study demonstrated the beneficial effects of the food supplement containing a mixture of EFLA®940 Pumpkin Seed Extract and soybean germ extract in pre- and postmenopausal women with stress urinary incontinence.
The intake of the EFLA®940 containing preparation quickly and significantly improved objective and subjective symptoms of women with stress urinary incontinence, resulting in an enhanced quality of life.

Reference:

Yanagisawa, Ei et al (2003). Study of Effectiveness of Mixed Processed Food Containing Cucurbita Pepo Seed Extract and Soybean Seed Extract on Stress Urinary Incontinence in Women.
Jpn J Med Pharm Sci; 14(3): 313-322. – 07.07

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