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.

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Non-Hormonal Contraceptive Device with Multiple Uses: Increases The Effectiveness of Fertility Awareness Methods and Controls Stress Incontinence

10.47363/jjcmr/2021(1)108 ◽

2021 ◽

pp. 1-6

Author(s):

Shihata Alfred ◽

◽

Brody Steven A ◽

Keyword(s):

Urinary Incontinence ◽

Stress Urinary Incontinence ◽

Cost Effective ◽

Hormonal Contraceptive ◽

Vaginal Fluid ◽

Contraceptive Device ◽

Barrier Method ◽

Pilot Studies ◽

Fertility Awareness ◽

Vaginal Anatomy

This article addresses three unmet women’s reproductive health needs, and how the FemCap can fulfill these needs. The FemCap is an FDA-approved, non-hormonal contraceptive device that can accommodate some deficient areas of women’s health: 1. A scarcity of hormone-free contraceptive methods. 2. Enhancement of fertility awareness method that is infrequently used but is the safest method. 3. Help Millions of women who suffer silently from stress urinary incontinence. The FemCap blocks sperm from entering the cervix. It is time-tested to be safe and effective for contraception. Using the FemCap directly at the cervix, it can collect the fertile cervical mucus without mixing it with any other vaginal fluid. Current pessaries used to treat stress urinary incontinence (SUI) have significant drawbacks, including displacement, erosion, ulceration, of the vagina and urethral blockage. The rim of the FemCap performs the same function as the ring pessary by supporting the bladder neck. The outward flared brim restores the urethra and vaginal anatomy. At the same time, the bowl of the FemCap keep the cervix from prolapsing further. The FemCap is a long-established barrier method of contraception, and pilot studies results show it can improve fertility awareness methods and manage Stress Urinary Incontinence. It would be ideal and cost-effective to have a single reusable device with several functions for contraceptives, increasing the acceptability and effectiveness of fertility awareness methods, and stress urinary incontinence control. The FemCap would be an ideal alternative to the condom.

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“I just wear it and I become normal”: a qualitative study of Tanzanian women’s experiences with long-term vaginal pessary use for stress urinary incontinence

BMJ Open ◽

10.1136/bmjopen-2020-040009 ◽

2021 ◽

Vol 11 (1) ◽

pp. e040009

Author(s):

Karina Holm Nissen ◽

Benjamin C Shayo ◽

Vibeke Rasch ◽

Gileard G Masenga ◽

Ditte Søndergaard Linde

Keyword(s):

Quality Of Life ◽

Urinary Incontinence ◽

Stress Urinary Incontinence ◽

Women’S Experiences ◽

Women's Experiences ◽

Vaginal Pessary ◽

Cost Effective Treatment ◽

Long Term Treatment

IntroductionPrevious research has shown that vaginal pessaries are a cost-effective treatment for women worldwide suffering from stress urinary incontinence. However, little is known about African women’s experiences with vaginal pessary use. The aim of this study was to understand the experiences of vaginal pessary use among Tanzanian women who had received long-term pessary treatment for stress urinary incontinence.Methods15 semi-structured, individual interviews were conducted over a 2-month period in 2019 with Tanzanian women living in the Kilimanjaro Region who suffered from stress urinary incontinence and who had been using a pessary for at least 18 months. The interview transcripts were analysed using qualitative content analysis.ResultsThe primary motivation for seeking treatment were discomfort from symptoms, social consequences and low quality of life. Perceived benefits from pessary use included improved quality of life with reacquired abilities to perform daily activities, participate in social gatherings, feeling symptom relief and improved sexual relations. Further, some women saw pessary treatment as superior to other locally available treatment options. Perceived barriers for pessary use included shame, husband’s disapproval, limited access to treatment and lack of knowledge among the women as well as healthcare personnel.ConclusionVaginal pessaries are well-perceived as a long-term treatment method among Tanzanian women suffering from stress urinary incontinence. This method may have potential to be implemented large scale in Tanzania if combined with basic health education.

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The Fertility Awareness Method and Managing Stress Urinary Incontinence (SUI), an Advanced Study

Highlights on Medicine and Medical Science Vol. 5 ◽

10.9734/bpi/hmms/v5/2568f ◽

2021 ◽

pp. 85-94

Author(s):

Shihata Alfred ◽

A. Brody Steven ◽

Linderoth Birgit ◽

Julia Barrett-Mitchell

Keyword(s):

Urinary Incontinence ◽

Stress Urinary Incontinence ◽

Fertility Awareness ◽

Advanced Study ◽

Managing Stress

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Successful Management of Stress Urinary Incontinence in Women by a Contraceptive Device FemCap™ Pilot Study

International Journal of Women’s Health Care ◽

10.33140/ijwhc.05.04.001 ◽

2020 ◽

Vol 5 (4) ◽

Keyword(s):

Urinary Incontinence ◽

Stress Urinary Incontinence ◽

Bladder Neck ◽

Contraceptive Device ◽

First Line ◽

Successful Management ◽

Ring Pessary ◽

Treatment And Prevention ◽

Menopausal Women ◽

Different Shapes

Background: Women suffer silently from stress urinary incontinence (SUI). SUI is under-reported by women and under-diagnosed and treated by doctors. Treatment with pessaries is conservative and has significant limitations. These limitations include displacement, erosion, ulceration, and urethral obstruction. (SUI) is very prevalent among women of all ages, particularly menopausal women. The first line of SUI treatment is the ring pessary; however, more pessaries of different shapes and sizes have been introduced to achieve better results. Objectives: To provide women with a safer, more effective device to treat SUI. Materials and Methods: The FemCap combines the ring and space-occupying pessary features into one device, making it much more successful. The bowl of the dome of the FemCap covers the cervix and prevents it from prolapsing. The rim fits snugly into the vaginal fornices that support the bladder neck. The brim flares outward, pushing against the cystocele and the urethrocele anteriorly to restore the urethra and the bladder’s anatomy. Forty-one women who had had significant SUI were recruited and asked to compare their experience for one week before using the FemCap and two weeks later. The FemCap was self-inserted and removed by the participants. Results: Thirty-four women out of 41 were completely dry after two weeks of using the FemCap, while four women were partially dry, and three women did not notice any change. The participants reported no side effects, and pelvic examinations did not show any erosion or ulceration of the vagina. Conclusion: The FemCap is safe and effective in restoring the bladder and urethra’s anatomy, which could make it ideal for the treatment and prevention of mild to moderate SUI. More studies are warranted to prove the utility of the FemCap further to manage SUI.

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