Clinical verification of the activity and tolerability of fitostimoline vaginal pessaries in women with hysterectomy : randomized, perspective, monoscentric study

Objective: To evaluate the activity of Fitostimoline® pessaries in comparison to the standard of care in the treatment of women with hysterectomy. Methods: An observational, randomized, perspective study performed on 60 women where 30 women were treated with Fitostimoline® pessaries for 12 days after surgery and 30 women were treated with the standard of care. A first follow-up visit was performed at 12 +/- 3 days and a final follow- up visit was performed at 40 +/- 3 days. Results: At the first control, 45% of patients in the Fitostimoline® group reported no evidence of vaginal bleeding after surgery; instead, 41% in the control group reported such result. At the final visit, 79% patients reported no evidence of vaginal bleeding in the Fitostimoline® group, while 63% in the control group. The medial duration of minor vaginal bleeding in the Fitostimoline® group was 11.8 days, whilst for discrete vaginal bleeding the medial duration was 4 days. In the control group instead it was 12 days, whilst for discrete vaginal bleeding the medial duration was 8 days. Conclusion: The use of Fitostimoline® ovules after hysterectomy is effective in reducing the quantity of vaginal bleeding, regardless the menopausal status, surgical approach and type of indication to surgery.