EFFECTS OF VAGINAL SPHERES COMBINED WITH PELVIC FLOOR MUSCLE TRAINING ON SEXUAL FUNCTION, URINARY INCONTINENCE, AND QUALITY OF LIFE: A PILOT RANDOMIZED CONTROLLED TRIAL

Sahra Sultan Kara, Esra Keleş, İsmail Bağlar, Yeliz Çeçen Dönmez, Fatih Şanlıkan, Beyzanur Kahyaoğlu

Pelviperineology - 2025;44(3):116-125

Department of Obstetrics and Gynecology, University of Health Sciences Türkiye, Kartal Dr. Lütfi Kırdar City Hospital, İstanbul, Türkiye

 

Objective: To evaluate the effects of pelvic floor muscle training (PFMT), with or without vaginal spheres (VS), on urinary incontinence severity, pelvic floor (PF) muscle strength, sexual function, and pelvic organ support in women. Materials and Methods: This single-center, two-arm, parallel-group pilot randomized controlled trial was conducted at a tertiary hospital between October 2024 and April 2025. Women aged 18-75 years with >=6-weeks of urinary incontinence and/or sexual dysfunction and PF muscle weakness (modified Oxford scale <=3) were recruited. Of 40 eligible candidates, 26 (65%) were randomized via sealed opaque envelopes to receive either PFMT-only (n=14) or PFMT with VS (VS+PFMT; n=12). Both groups completed a 6-week home-based PFMT protocol; the VS+PFMT group additionally used VS daily during light physical activity. Blinded assessors evaluated PF muscle strength (modified Oxford scale), urinary symptoms (ICIQ-SF and SSI), female sexual function index (FSFI), and pelvic organ support (POP-Q). Feasibility metrics included recruitment, retention, adherence, and safety. Results: Of 26 participants, 14 (54%) completed the intervention (7 per group). Attrition was primarily due to time constraints and exercise fatigue. Two participants in the VS+PFMT group reported mild vaginal burning. Assessment and exercise log compliance were high. Within- group analysis showed statistically significant improvements in FSFI scores (Delta=+2.53; p=0.002), ICIQ-SF scores (p=0.043), PF muscle strength (p=0.001), and POP-Q measurements (p=0.008). No significant between-group differences were observed in clinical outcomes. Conclusion: Adjunctive use of VS with PFMT appears to be a safe, feasible, and well-tolerated intervention. Within-group improvements suggest potential therapeutic benefit in PF function and sexual health.