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.
Clinical verification of the activity and tolerability of fitostimoline vaginal pessaries in women with hysterectomy : randomized, perspective, monoscentric study / M. Grandinetti, L. Nazzaro, R. Izzo, M. Vignali. - In: OBSTETRICS AND GYNECOLOGY: OPEN ACCESS. - ISSN 2577-2236. - 6:1(2022 Jan 28), pp. 143.1-143.7. [10.29011/2577-2236.100143]
Clinical verification of the activity and tolerability of fitostimoline vaginal pessaries in women with hysterectomy : randomized, perspective, monoscentric study
M. Grandinetti
Primo
;L. NazzaroSecondo
;M. VignaliUltimo
2022
Abstract
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.File | Dimensione | Formato | |
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