Vaginal Spheres Versus Pelvic Floor Muscle Training in the Treatment of Urinary Incontinence and Sexual Dysfunction: A Randomized, Single-Blind, Controlled Trial

Author:

BLANCO-RATTO Laia1,RAMIREZ-GARCIA Inés2,KAUFFMANN Stephanie1,ORTIZ Cristina NARANJO3,FARRES Montserrat GIRABENT4

Affiliation:

1. RAPBarcelona Physiotherapy Clinical Center

2. Blanquerna School of Health Science, Ramon Llull University

3. Yale University

4. Campus Docent Sant Joan de Déu-Universitat de Barcelona

Abstract

Abstract

Background Female sexual dysfunction is closely linked to pelvic floor muscle dysfunction, especially in the context of urinary incontinence. While pelvic floor muscle training can be performed through exercises alone or with intravaginal medical spheres, the benefits of incorporating these devices into therapy remain unclear. This study aimed to compare the efficacy of pelvic floor exercises combined with vaginal spheres versus exercises alone in improving stress and stress-predominant mixed urinary incontinence and sexual function. Methods This randomized, single-blind trial was conducted at the RAPBarcelona Center and included 71 adult women with stress or stress-predominant mixed urinary incontinence and sexual dysfunction. Participants were randomly assigned to either pelvic floor muscle exercises alone (control group) or exercises combined with vaginal Enna Balls (intervention group), and the intervention period lasted four months, with assessments at baseline and follow-ups at 8 and 16 weeks. The primary outcome measure was the impact on incontinence, which was assessed using the ICIQ-UI-SF questionnaire. Secondary outcomes included sexual function, measured by the Female Sexual Function Index, and monitoring of adverse events and treatment adherence at weeks 4, 8, 12, and 16. Results The mean age of participants was 46.85 ± 1.58 years. Post-treatment, the ICIQ-UI-SF score significantly decreased from 9.01 ± 0.52 to 3.92 ± 0.59 (p < 0.05). No significant changes were observed in the overall Female Sexual Function Index score (p > 0.05), except for an increase in desire, which showed statistical differences between groups at the end of treatment (p = 0.041). Tolerance and adherence to the interventions did not significantly differ between groups. Conclusions Home-based pelvic floor muscle training, both with and without vaginal spheres, is effective and safe for women with stress urinary incontinence or stress-predominant mixed urinary incontinence and sexual dysfunction. Vaginal spheres are particularly recommended for their safety, popularity, and ability to enhance female desire. However, they do not significantly improve overall female sexual function in the short term. Further research is needed to explore their long-term benefits and broader impacts on sexual health. Trial Registration: The study was registered on clinicaltrials.gov with the identifier NCT05732844 on January 29, 2023. More details can be found at (https://www.clinicaltrials.gov/study/NCT05732844?term=NCT05732844&rank=1&tab=history&a=1#version-content-panel)

Publisher

Springer Science and Business Media LLC

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