Background and Objectives: Stress urinary incontinence (SUI) negatively affects women's quality of life, including sexual function. The aim of the current study was to evaluate the effect of polydimethylsiloxane (Macroplastique®) on sexual function in women of fertile age affected by SUI. Materials and Methods: Single-center prospective study. Sexually active women of fertile age with symptoms of pure SUI, which were urodynamically proven, were submitted to intraurethral Macroplastique® injection. At 6-months follow-up, their sexual function was evaluated with Female Sexual Function Index (FSFI), while the SUI cure rate was objectively assessed through a negative stress test and subjectively by a Patient Global Impression of Improvement (PGI-I) score < 3. The difference of coital incontinence prevalence was assessed between the baseline and the 6-month follow-up. Peri- and postoperative complications of Macroplastique® injection were recorded and classified according to the Clavien-Dindo system. Results: Twenty-one women fulfilled inclusion criteria and were submitted to Macroplastique® procedure. The concerning sexual function, desire, satisfaction, and overall FSFI score significantly improved. Since other domains were less impaired at the baseline, we could not assess significant improvement for all of them. We observed a complete regression of coital incontinence (0/21, 0%) in comparison with the baseline (5/21, 23.8%; p = 0.04). The objective SUI cure rate was 76% (16/21), while the subjective SUI cure rate was 80.9% (17/21). One woman developed de novo overactive bladder, and two women developed postoperative voiding dysfunction (self-solved in 24 h). Conclusions: The Macroplastique® urethral injection was demonstrated to be safe and effective in improving sexual function in sexually active women of fertile age affected by pure SUI, urodinamically proven at 6-months follow-up.
Keywords: Macroplastique; bulking agents; polydimethylsiloxane; sexual function; stress urinary incontinence; urethral bulking agents.