Treatment of vulvovaginal atrophy using vaginal dilators in addition to usual care : a randomized controlled feasibility trial

To evaluate the feasibility, acceptability, and preliminary efficacy of adding vaginal dilators (VD) to standard therapy for genitourinary syndrome of menopause (GSM). A prospective, randomized pilot trial was conducted at CHU Saint-Pierre, Brussels. Peri- and postmenopausal women with GSM were randomized to standard therapy alone or standard therapy plus VD. Assessments at baseline (T0), 4 weeks (T1), and 12 weeks (T2) included the Female Sexual Function Index (FSFI), Vaginal Health Index Score (VHIS), Visual Analog Scale (VAS) for pain, and GSM symptom questionnaires. Feasibility and acceptability were evaluated through adherence, retention, and patient-reported outcomes. Fifteen women were randomized; 11 completed 12 weeks (5 control, 6 VD). At T1, the VD group reported significant improvements in arousal (+ 32.1%, p = 0.030), orgasm (+ 7.3%, p = 0.030), vulvar symptoms (–43.8%, p = 0.013), and pain (–37.5%, p = 0.020). At T2, significant gains were observed in FSFI total score (+ 25.7%, p = 0.028), lubrication (+ 31.2%, p = 0.017), and orgasm (+ 29.2%, p = 0.021). No adverse events occurred. Feasibility was high : 54% of eligible women consented, with a retention rate of 93%. Most participants found VD use acceptable and compatible with daily life. The addition of VD to standard GSM therapy was feasible, well accepted, and associated with some improvements in sexual function and symptoms. Given that only 15 women were randomized and 11 completed follow-up, statistically significant findings are presented as exploratory and hypothesis-generating rather than evidence of clinical effectiveness. Larger, multi-center, longer-term trials are warranted to confirm these findings. (Clinical Trials.gov NCT06828640 Date of registration 20250214. Retrospectively registered)