Alfred Shihata
USA
Title: Novel Delivery System, Alternative to the Vaginal Applicator, To Treat Bacterial Vaginosis and Candida
Biography:
Dr. Alfred Shihata, President/CEO of FemCap Inc., invented FemmyCycle menstrual cup and FemCap cervical cap. He is affiliated with Scripps Institutions of Medicine & Science and holds medical degrees in England, Canada and the USA. He has six patents and brings over four decades of women’s reproductive health research as a medical device designer. He received the “Why Didn't I Think of That?” award from BIOCOM, Southern California’s largest biotech trade association. He has published in the New England Journal of Medicine and other medical/scientific journals. * Dr. Shihata is a Life Member of the Society of American Inventors and the Association of Reproductive Health Professionals
Abstract:
Globally 1.9 billion women are of menstruating age. Menstrual cups are gaining more popularity among women, who prefer cups over pads and tampons. [1]. The innovative FemmyCycle (Figure 1) has several advantages over traditional menstrual cups. (Figure 2) Objective: To mitigate and correct the side effects caused by traditional menstrual cups. The most common side effect among traditional cups is leakage.
Methodology: We focused our study on all causes of leakage and other side effects caused by traditional menstrual cups. Methods of corrective and preventive actions included; the no-spill design, the use of a removal ring instead of a rigid stem, the use of a flask shaped body rather than the conical shape of traditional menstrual cups (Figure 2), and the elimination of suction holes as well as the need to manually open the cup. (Figure 3 & 4) We analyzed 834 independent reviews by women who have had prior experience with traditional menstrual cups to obtain objective results. Findings: The implementation of these design changes and enhancements of the written and digital instructions produced measurable, positive results in favor of the FemmyCycle. We analyzed all the reviews for FemmyCycle to measure the prevention of leakage and other side effects. We selected the reviewers who volunteered to compare the FemmyCycle with their experience using traditional cone shaped cups. There were many reasons why women preferred FemmyCycle, but the most common by far was the prevention of leakage followed by the ease of insertion, ease of removal and comfort when inserted. Conclusion: The implementation of the design changes from a conical shaped cup with a removal stem to a flask shape cup with a removal ring, in addition to the added no-spill feature and enhanced instructional material, improved the acceptability of the FemmyCycle.
Alfred Shihata
USA
Title: Novel Delivery System, Alternative to the Vaginal Applicator, To Treat Bacterial Vaginosis and Candida
Biography:
Dr. Alfred Shihata, President/CEO of FemCap Inc., invented FemmyCycle menstrual cup and FemCap cervical cap. He is affiliated with Scripps Institutions of Medicine & Science and holds medical degrees in England, Canada and the USA. He has six patents and brings over four decades of women’s reproductive health research as a medical device designer. He received the “Why Didn't I Think of That?” award from BIOCOM, Southern California’s largest biotech trade association. He has published in the New England Journal of Medicine and other medical/scientific journals. * Dr. Shihata is a Life Member of the Society of American Inventors and the Association of Reproductive Health Professionals
Abstract:
Vaginal applicators have been used for centuries to deliver therapeutic creams into the vagina. The physiologic, rhythmic contraction of the vagina expels menstrual fluid and cervical secretions as well as creams, which renders them less effective.
Objectives: (A) To provide women with an alternative to the use of vaginal applicators, so that vaginal preparations remain in contact with the cervix for longer periods of time.(B) To explore the feasibility of treating Bacterial Vaginosis, Candida infections, and some STIs, by using a new cervical barrier, called FemCap, as a delivery system for antibacterial and antifungal preparations.
Methodology: To prove this concept we recruited 20 women to insert a stained gel with Gentian violet using an applicator. Another group of 20 women used FemCap to insert the same gel. We then compared the retention and distribution of the stained gel over the cervix. Participants were provided with pads to monitor the expulsion of the stained gel. Photographs of the cervices were taken at 12 and 24 hours.
Results: The participants didn’t report any side effects using the stained gel with either device. Women reported leakage while using the applicator; this didn’t occur with FemCap. Women who used the applicator had no visible stained gel over the cervix after 12 hours of insertion. Photographs showed that FemCap participants retained the stained gel on the cervix for 24 hours after insertion.
Conclusion: This pilot study has proven the concept that FemCap is more efficient than the applicator in delivering vaginal preparations to the cervix. The FemCap shields the cervix from sperm penetration and potentially the invasion by STI organisms. Further studies are warranted to explore the possibility of treating Bacterial Vaginosis and Candida topically, and some STI’s, such as gonorrhea and chlamydia. chlamydia.