EFFICACY AND USER ACCEPTABILITY OF THE URETHRAL OCCLUSIVE DEVICE IN WOMEN WITH URINARY INCONTINENCE

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Abstract
We determine the efficacy and user acceptability of the urethral occlusive device (FemAssist*) for incontinence for 1 month and identify factors that may predict successful use of the device. Baseline and posttreatment outcome measures included a 1-hour pad test, frequency volume chart (leakage, voiding and number of pads per 24 hour), visual analog scale for incontinence impact and quality of life (Urogenital Distress Inventory). The last 36 consecutive women also completed a linear analog scale about attitudes toward touching the genitalia. The device was offered to 100 consecutive incontinent women of whom 3 did not enroll in the study and 57 (57%) completed the 1-month trial. Age, incontinence type or severity and attitudes about touching the genitalia were not significantly different between dropouts and participants. Only 13% of recruits were disinclined to place the device on the urethra. Significant reduction of incontinence was observed for all outcome measures with the device in situ. Pad testing revealed that 47% of the patients became continent and 33% had more than 50% benefit, while 9% had worse leakage. Those with severe baseline leakage were equally likely to respond as those with mild or moderate pad test loss. Women with stress, urge or mixed incontinence appeared to respond equally well. The urethral occlusive device provides a further nonsurgical treatment option which is useful for a range of incontinence types.