Contraceptive Device Discovered to Have Broad Spectrum Application for Women’s Basic Unmet Needs

Introduction: The FemCap is an FDA, and CE mark approved barrier contraceptive device. To our surprise, it was found to apply to several basic unmet reproductive health needs for women. a) The FemCap is time tested hormone-free contraceptive device, b) It offers an alternative delivery system to the traditional vaginal applicator, c) It provides a safe and effective non-surgical treatment for stress urinary incontinence (SUI), d) It enhances the fertility awareness methods. Methodology: We conducted several pilot studies to explore the potential of the FemCap. We compared the retention and distribution of stained vaginal gel if inserted with the FemCap versus the same amount of gel when inserted by the vaginal applicator. We compared the safety and effectiveness of the FemCap with a vaginal pessary that treats stress urinary incontinence. We collected the fertile cervical mucous (Spinnbarkeit) with the FemCap to determine the time of ovulation to enhance the fertility awareness method. Results: The FemCap is a well-established, safe, and effective non-hormonal contraceptive. The retention and distribution of stained vaginal gel inserted with the FemCap is more efficient than the vaginal applicator. The FemCap’s unique storage groove for microbicides can potentially be utilized to treat sexually transmitted infections (STIs) topically. FemCap is also found to be substantially equivalent to the incontinence pessary in controlling stress urinary incontinence (SUI). The FemCap did also help to collect fertile cervical mucous (Spinnbarkeit) when using fertility awareness methods. Conclusion: The multipurpose FemCap would be an ideal tool for nurse practitioners, midwives, and physicians to provide women with safe and effective, hormone-free contraception. It also provides an efficient delivery system for spermicide/microbicides. It is much safer for non-surgical management of stress urinary incontinence. It is useful for the enhancement of fertility awareness methods. It is non-invasive and can be inserted and removed by the woman without professional help.

Induced Dryness Stress on Human Vaginal Epithelium: The Efficacy of a New Vaginal Gel

An experimental model of dryness on vaginal mucosa is proposed to assess the efficacy of a new vaginal gel (Respecta® Hydragel Ref 17031). The dryness model was induced on reconstituted human vaginal epithelium (HVE) by incubating the tissues in modified environmental conditions (R.H. < 50% and T = 40 °C) for 48 h. The products were applied on the ‘Dry’ HVE models for 24 h (series 48 h + 24 h) in standard culture conditions (37 °C 5% CO2). Their efficacy in counteracting vaginal dryness was assessed and compared to tissues treated with saline solution and cultured in standard culture conditions (negative control) and to untreated tissues incubated in dryness conditions for 48 h and then recovered after 24 h in standard culture conditions (positive control). The products’ efficacy was quantified by measuring the following parameters: (1) water flux and direct moisturization by AQP3 immunohistochemical staining, and (2) maintenance of moisturization and elasticity of the mucosa by hyaluronic acid (CD44) immunofluorescence staining. Respecta® Hydragel demonstrated efficacy in regulating the water flux by inducing AQP3 expression thus determining a positive water balance within the vaginal epithelium. It induced a remodelling of the epithelium morphology with restored trophism compared to the dry HVE control. Furthermore, it demonstrated a significant increase of the expression of CD44, related to hyaluronic acid (HA) distribution in the extracellular matrix. HA has the ability to act on the cellular matrix composition and its renewal compared to the dry HVE control. Through these mechanisms it induces a deep hydration and elasticity of the vaginal mucosa.