ADVANCED DEVICE TO TREAT FEMALE URINARY INCONTINENCE

Electrosonics Medical Inc, Cleveland OH

Investigators

Abstract

Stress urinary incontinence afflicts 20% of women. The lifetime risk of undergoing a single surgery for either prolapse or incontinence by age 80 is reported to be greater than 11%. For many women, however, surgery is not a viable option. The use of vaginal inserts, known as pessaries, to help control incontinence is an effective option, relieving the symptoms in 80% of users. These devices are not without drawbacks. For many women, the devices are uncomfortable or difficult to deal with resulting in as many as 50% of the users abandoning the devices within the first year of use. We are proposing to examine the use of some advanced materials to improve the interface and vaginal canal filling properties of these devices. The use of these new materials will improve the fit to the female anatomy and ease insertion of the devices. The goodness of fit of the devices will be assessed qualitatively by a series of cadaveric experiments using MR and CT images and qualitatively by two skilled clinicians. The quantitative and qualitative scores will be correlated and those designs which meet our standards will be used in Phase II to determine their clinical efficacy. PROPOSED COMMERCIAL APPLICATIONS: In the United States, over $16 billion are spent annually on incontinence related care. An additional $1.1 billion are spent on disposable absorbent products. If the consequences due to incontinence are included, the total annual expenditures related to urinary incontinence approached $28 billion in the United States alone. The market for intra- vaginal devices is expected to exceed $320 million dollars by the end of 2001. We project that the market share for the new devices we develop will fall within the 2-5% range or $6.4 to $16 million dollars annually.