Effect of Vaginal Spheres and Pelvic Floor Exercises on Female Sexual Function in Women with Urinary Incontinence: A Randomized Controlled Trial (Secondary Analysis)

Background: Female sexual dysfunction (FSD) is common in women with urinary incontinence (UI), and pelvic floor exercises (PFEs) are a well-established treatment. Vaginal spheres, designed to stimulate pelvic floor muscle engagement, may offer additional benefits in improving sexual function. Objective: To assess the efficacy of a regimen of PFEs combined with vaginal spheres with the same exercises performed without any device to improve sexual function. Methodology: This randomized, single-blind trial conducted at the RAPbarcelona Center enrolled 71 adult women with sexual dysfunction symptoms. Participants were assigned to either PFEs alone or combined with vaginal Enna Balls. The intervention lasted 4 months, with initial assessments at baseline and follow-ups at 8 and 16 weeks. The Female Sexual Function Index assessed sexual function. Adverse events and treatment adherence were monitored at weeks 4, 8, 12, and 16, and follow-ups. Results: The mean age of participants was 46.85±1.58. After treatment, no significant changes were observed in the overall Female Sexual Function Index score (≥0.05), except for an increase in desire, showing statistical differences between groups at the end of treatment (p = 0.041). Tolerance and safety did not significantly differ between groups. Conclusions: Adding vaginal spheres to PFEs may offer specific benefits in enhancing aspects of sexual function, particularly desire and lubrication, though overall outcomes were similar to PFEs alone. These findings support the potential role of vaginal spheres as an adjunctive therapy in personalized pelvic floor rehabilitation strategies for women with FSD.