A safety and quality of life analysis of intravaginal slingplasty in female stress incontinence: a prospective, open label, multicenter, and observational study.

Abstract

This prospective, open label, multicenter, and observational study was performed to determine the efficacy, safety, and the impact of this procedure on the current quality of life (QOL). One hundred three women underwent the intravaginal slingplasty (IVS) procedure. The postoperative evaluation consisted of clinical examination, Incontinence Quality of Life (I-QOL) questionnaire, 3-day consecutive frequency volume chart, free flowmetry, and measurement of post void residual. At 12 months, 83 patients have completed follow-up and are included in this analysis. Patient assessment of continence revealed 89.2% (74/83) cure rate. During follow-up period, one patient (1.2%) has presented with vaginal erosion of the sling material. The I-QOL showed significant improvement in total and three subscale scores at 12 months of follow-up period. This study demonstrated that the IVS procedure provides a safe and effective means for the treatment of female stress incontinence and improvement of QOL.