Effect of the Macroplastique Implantation System for stress urinary incontinence in women with or without a history of an anti-incontinence operation.

INTRODUCTION AND HYPOTHESIS

We evaluated the outcomes and the effect of the Macroplastique Implantation System on the quality of life in women with stress incontinence with or without a history of an anti-incontinence operation during 12 to 62 months follow-up.

METHODS

Thirty-five women with urodynamically proven stress incontinence with intrinsic sphincter deficiency were included in this study. Macroplastique injection was performed in all patients. Quality of life was evaluated prior to therapy, in early postoperative time (at the sixth weeks) and in late postoperative time (12 to 62 months follow-up) with the use of three different questionnaires: Incontinence Quality-of-Life Questionnaire (I-QOL), Incontinence Impact Questionnaire-7 (IIQ-7), and Urogenital Distress Inventory-6 (UDI-6). Questionnaires were also compared with those previous to the anti-incontinence operation and to the primary procedure groups.

RESULTS

The median age of the women was 50.00 (interquartile range = 17.00) years. There were 24 primary procedures and 11 had undergone previous anti-incontinence surgery. Maximum follow-up time was 62 months, minimum follow-up time was 12 months, and the median follow-up time of the study was 58 (interquartile range = 44-60) months. When preoperative and postoperative median of the I-QOL, IIQ-7, and UDI-6 scores were compared, the differences between scores were found to be statistically significant. I-QOL, IIQ-7, and UDI-6 scores were related to the previous surgery. The overall I-QOL, IIQ-7, and UDI-6 summary scores showed high internal consistency.

CONCLUSIONS

The Macroplastique injection system is an effective, safe, and acceptable option for stress urinary incontinence in women with or without a history of an anti-incontinence operation. Moreover, it can be performed under local anesthesia without cystoscopic guidance; moreover, side effects are rare.