International Journal of Women's Health Care(IJWHC)
ISSN: 2573-9506 | DOI: 10.33140/IJWHC
Impact Factor: 1.011*
Ongoing Research for Managing Stress Urinary Incontinence in Women with a FDA Approved Device, The FemCap
Abstract
Shihata Alfred, Brody Steven A, Linderoth, Birgit
Background: The previous successful pilot study led the inventor to expand into Sweden and increase the number of participants. We also expanded the research comparing the FemCap to other Pessaries on the market. Pessary treatment is conservative with significant limitations. These limitations include displacement, erosion, ulceration, and urethral obstruction. Stress urinary incontinence (SUI) is prevalent particularly among menopausal women. The first line of SUI treatment is the ring pessary however, a variety of different pessaries have been introduced into the market with hope of achieving better results.
Objectives: To provide women with a safer, more effective device to treat SUI.
Materials and Methods: The FemCap combines the features of the ring and space- occupying pessaries into one device, which makes it 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 supports the bladder neck. The Brim flares outward pushing against the cystocele and urethrocele anteriorly to restore the anatomy of the urethra and the bladder. We recruited 118 women who had significant SUI and asked them to compare their experience for one week before using the FemCap and one week after. The FemCap was self-inserted and removed by the participants.
Results: Only 100 women completed the study 94 were completely dry after one week, while 6 women were not satisfied with the results. No side effects were reported by the participants and pelvic examinations did not show any erosion or ulceration of the vagina.
Conclusion: The FemCap is safe and effective in restoring the anatomy of the bladder, and urethra, which could make it ideal for the treatment and prevention of mild to moderate SUI. More studies are warranted to further prove the utility of the FemCap to manage SUI.