Evaluation of new intraurethral occlusive depot (ORIS FEMININO) in the management of female stress urinary incontinence

OBJECTIVE: To determine the utility and safety of an intraurethral device (Oris Femenino) in the management of female stress urinary incontinence. METHODS: A prospective clinical study was conducted on 54 female patients, mean age 46.4 years, with stress urinary incontinence. The degree and severity of the incontinence was determined before and one month after treatment with the intraurethral device. The reasons for the dropouts were analyzed and the rehabilitative effects two months after treatment had been completed were evaluated in 22 patients. RESULTS: 83% of the patients who completed the study referred positive results. A significant improvement was demonstrated for the degree of incontinence as well as the number of absorbent pads used. Age and severity of incontinence inversely correlated with positive results. A correlation between the absence of a previous urethropexy and positive results was also found. The dropout rate was 44% (24 patients) and was chiefly due to symptomatic bacteriuria in 14 cases and the difficulty in fixation and degree of incontinence. A statistically significant reduction was found in the number of pads used in the group of patients evaluated two months after treatment had been completed. CONCLUSIONS: The intraurethral device analyzed in this study significantly reduced urinary incontinence. This method appears to be more effective in younger women who are not severely incontinent and have not previously undergone urethropexy. The intraurethral device appears to have some rehabilitative effect on the perineal muscle. Symptomatic bacteriuria was found to be the main disadvantage.