Preliminary experience with a urinary control device in the management of women with genuine stress incontinence.

ABSTRACT

OBJECTIVE: To evaluate the efficacy and acceptability of the FemAssist urinary control device (Insight Medical UK Ltd). PATIENTS AND METHODS: Twenty-seven women with cystometrically confirmed genuine stress incontinence performed a perineal 1 h pad-test; the pad test was then repeated with the FemAssist device in place and the difference in pad weights compared with and without the device in place. Patients were given 100 mm visual analogue scales (VAS) to measure discomfort, acceptability and embarrassment associated with using the device. RESULTS: The median (range) loss with and without the FemAssist device was 4.9 (0-65) mL and 21 (1-94), respectively (P < 0.01); 20 patients were less wet when using the device. The median (range) VAS scores were; discomfort 35 (4-93), embarrassment 11 (0-75), and acceptability 65 (3-100). Discomfort was greater among the women with a greater loss. The acceptability correlated negatively with discomfort (r = -0.53) and negatively with embarrassment (r = -0.39); 15 patients (56%) reported that they would use the device in the long-term. CONCLUSION: The FemAssist device produced a significant reduction in urine loss. The magnitude of benefit could not be predicted for an individual and the device was ineffective in some women. The use of the device was influenced by discomfort and associated embarrassment. The device has a role in the management of stress incontinence but patients must be assessed individually for suitability.