Study of Go-Less® on nocturia in women in an open clinical study
• EFLA®940 Pumpkin seed extract
• SoyLife – Soy germ extract
Study summary
To investigate the efficacy and safety of Go-Less® on nocturia women, an open clinical study was performed on postmenopausal women in Japan.
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 167mg 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 effect of Go-Less® in pre- and postmenopausal women with bladder control issues. From the results of this study, it may be concluded that the intake of Go-Less® quickly, continuously and significantly improved subjective symptoms and quality of life of women with bladder function problems.
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