(098) Impact of Device-Assisted Pelvic Floor Training on Urinary and Orgasmic Function in Women with Stress Urinary Incontinence: A Prospective Cohort Study

Introduction Stress urinary incontinence (SUI) and orgasmic dysfunction frequently coexist, sharing pelvic floor muscle weakness and reduced proprioceptive feedback as underlying mechanisms. Conventional pelvic floor muscle training (PFMT) is the recommended first-line therapy, but its real-world effectiveness is often limited by poor adherence and uncertainty about correct contraction technique. Device-assisted progressive vaginal training may enhance muscle recruitment and sensory feedback, thereby improving both urinary control and orgasmic function. Objective This study aimed to compare the effects of a 10-week device-assisted PFMT program using a vaginal weighted system (Pelvix®, Spain) with a conventional 12-week Kegel regimen on urinary and orgasmic outcomes in women with clinically diagnosed SUI. Methods A prospective, non-randomized cohort study was conducted in women of reproductive age with SUI and no previous pharmacologic or surgical treatment. Participants were allocated according to preference or clinical indication to either a 10-week home-based PFMT program with the Pelvix® device under weekly supervision or to a standard 12-week Kegel exercise protocol following guideline recommendations. Both cohorts were assessed at baseline and after the intervention using the International Consultation on Incontinence Questionnaire–Urinary Incontinence Short Form (ICIQ-UI SF) to measure incontinence severity, the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire–IUGA Revised (PISQ-IR, Question 10) to assess orgasmic function, and the Patient Global Impression of Change (PGIC) to evaluate perceived improvement. Within-group comparisons were analyzed using paired t-tests or Wilcoxon signed-rank tests, and between-group comparisons of changes (Δ = Post – Pre) were performed using independent t-tests or Mann–Whitney U tests, as appropriate. Results Seventeen women were included in the Pelvix® cohort and sixteen in the Kegel cohort. The mean age was 43.1 ± 8.3 years and 38.4 ± 8.6 years, respectively. Both groups showed significant improvement in ICIQ-UI SF and PISQ-IR scores (all p < 0.001). The reduction in incontinence severity was greater in the Pelvix® group (mean ΔICIQ = −5.4 ± 1.7) than in the Kegel group (mean ΔICIQ = −3.9 ± 1.9; p = 0.03). Likewise, the increase in orgasmic function was higher in the Pelvix® cohort (mean ΔPISQ = +2.2 ± 0.8) than in the Kegel cohort (mean ΔPISQ = +1.6 ± 0.7; p = 0.04). According to PGIC responses, 88% of participants in the Pelvix® group rated themselves as “much” or “very much improved.” No adverse events were reported, and adherence exceeded 90% in both cohorts. Conclusions The 10-week device-assisted PFMT program using Pelvix® produced significantly greater improvements in urinary control and orgasmic function compared with a conventional 12-week Kegel regimen. These findings suggest that progressive vaginal loading and enhanced proprioceptive feedback may amplify both continence recovery and sexual responsiveness. Device-assisted PFMT appears to be a safe and effective conservative intervention for women with SUI and orgasmic dysfunction, meriting confirmation in larger randomized controlled trials. Disclosure Yes, this is sponsored by industry/sponsor: Cnex Clarification: Industry funding only - investigator initiated and executed study Any of the authors act as a consultant, employee or shareholder of an industry for: Cnex