Objective: This study was undertaken in order to determine if the "Femassist" 
device is a safe and effective treatment for women with the diagnosis of urinary 
incontinence.Methods: The Femassist is a medical-grade silicon dome-shaped 
device, worn over the urethra and held securely via suction and a commercially 
available adhesive lotion. Women with a chief complaint of urinary incontinence 
responding to local newspaper advertisements were screened for inclusion. 
Potential candidates underwent medical history, physical (including gynecologic) 
examination, Papanicolaou test, urine culture and cytology, and multichannel 
urodynamic testing (including abdominal leak-point pressure measurements). A 
total of 38 women with documented genuine stress urinary incontinence (GSUI) or 
mixed incontinence were ultimately recruited into the study and fitted with 
either the standard or petite-sized Femassist device, according to their 
individual anatomy. Subjects were assessed before and after 1 month's use. 
Subjective assessment included quality of life questionnaires, daily voiding and 
activity diaries, as well as ongoing patient comments retrieved through daily 
telephone contact with the study nurse. Objective assessment included blinded 
evaluation of bacteriuria and urinary infection rates and vulvar irritation and 
ulceration rates.Results: To date, of the 38 women who have completed the study, 
over 50% reported an improvement in their quality of life including comfort, 
convenience, and overall satisfaction. In total for all patients studied, the 
device was worn for a total of 886 days; 82% of these were dry days. Similar 
results were obtained for women with GSUI and mixed incontinence. Factors 
associated with successful experience with the device included degree of tissue 
estrogenization (either naturally or via a topical estrogen preparation), manual 
dexterity, and degree of motivation. One in five women reported vulvar 
irritation or urethral discomfort at some point; this was not correlated with 
percentage of dry days. There have been no reported significant increases in 
bacteriuria or urinary tract infection rates over patients' baseline 
experiences.Conclusion: Our preliminary study suggests that the Femassist device 
is a safe and effective method for the management of female urinary 
incontinence.