Authors: Shihata Alfred A, Brody Steven
Introduction: Vaginal applicators are used for centuries, to deliver creams and gels, into the vagina. The physiologic rhythmic contraction of the vagina is responsible for quick expulsion of menstrual fluid and cervical secretions as well as therapeutic vaginal creams which are rendered less effective.
Objectives: (A) To Provide women with an alternative to vaginal applicators, to maintain therapeutic vaginal preparations in contact with cervix for longer time.
(B) Explore the feasibility for treatment of Bacterial Vaginosis, Candida infections; as well as 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 the vaginal applicator and another 20 women to use the FemCap to insert same gel into their vaginas. 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. We also photographed the cervices at 12 and 24 hours.
Results: None of the participants reported any side effects using the stained gel with either device. Women reported leakage while using the vaginal applicator and did not with FemCap. Women who used the applicator had no visible stained gel over the cervix after 12 hours of insertion. Cervical photographs have shown that the FemCap participants retained the stained gel on the cervix more than 24 hours after insertion.
Conclusion: This pilot study has proved the concept, that FemCap is more efficient than the vaginal applicator in delivering vaginal preparations to cervix. The FemCap can shield the cervix from sperm penetration and potentially from STI organism’s invasion. Further studies should be conducted to explore the possibility to treat Bacterial Vaginosis, Candida topically, and some STI’s, such as gonorrhea and chlamydia.
View/Download pdf