The “Femassist”: a new device for the treatment of female urinary incontinence

Abstract

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.