Efficacy and safety of a novel disposable intravaginal device for treating stress urinary incontinence.
OBJECTIVE
The purpose of this study was to evaluate the efficacy and safety of a novel disposable intravaginal device for treatment of stress urinary incontinence (SUI) in women.


METHODS
Sixty women with severe SUI were recruited from 2 sites in Israel to wear preweighed pads during a 7-day control period followed by a 28-day device usage period in which the device and preweighed pads were worn daily for 8 hours. The primary endpoint was the percentage of women who achieved a > or = 70% reduction in pad weight gain (PWG) from the control period to the last 14 days of device usage.


RESULTS
Sixty women who enrolled into the study and used the device for any period of time were included in the intent to treat (ITT) population. Eighty-five percent of them achieved a > or = 70% reduction in PWG (P = .01). Improvements in overall quality of life, subjective perception of incontinence, and satisfaction with the device were observed.


CONCLUSIONS
The intravaginal device is easy to use, well-tolerated, and effective in reducing SUI.
Ziv
Elan
E
Urogynecology Service, Assuta Medical Centers, Tel Aviv, Israel. zivelan@netvision.net.il
Stanton
Stuart L
SL
Abarbanel
Joseph
J
D000293:Adolescent; D000328:Adult; D000368:Aged; D004209:Disposable Equipment; D004867:Equipment Design; D005260:Female; D006801:Humans; D016496:Incontinence Pads; D008875:Middle Aged; D010146:Pain / Q000453:epidemiology; D017060:Patient Satisfaction; D010570:Pessaries; D019736:Prostheses and Implants; D011788:Quality of Life; D016896:Treatment Outcome; D014550:Urinary Incontinence, Stress / Q000628:therapy*