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

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.