Geburtshilfe Frauenheilkd 2020; 80(10): e203
DOI: 10.1055/s-0040-1718174
Poster
Mittwoch, 7.10.2020
Gynäkologische Onkologie III

Efficacy on cytological findings. i.e. ASC-US, LSIL, ASC-H, and HSIL of an environment modifying vaginal gel – novel management for the prevention of cervical cancer: a subanalysis of a randomized controlled trial

Regidor PA
1   Exeltis Germany GmbH, Medical Department, Ismaning, Deutschland
,
M Sailer
1   Exeltis Germany GmbH, Medical Department, Ismaning, Deutschland
,
A Müller
1   Exeltis Germany GmbH, Medical Department, Ismaning, Deutschland
,
A Major
2   HFR Fribourg Cantonal Hospital, Gynecology and Obstetrics, Fribourg, Schweiz
› Author Affiliations
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    Objectives The present clinical trial aimed to study the effect of a treatment with SAM vaginal gel on cytopathological findings. SAM vaginal gel is a medical device containing adsorptive silicon dioxide and an antioxidative citric acid/selenium combination.

    Patients and methods 216 women aged 25-60 years participated in this study at three colposcopy centers. They were randomized to either receive an intravaginal daily dose of SAM gel for three 28-days periods or be followed-up clinically without intervention. The outcome was cytological efficacy, analyzed as regression, remission, persistence and progression. At baseline, all participants had colposcopy-guided biopsies. At 3 months, they had a cervical smear for cytology, hr-HPV and p16/Ki-67 (CINtec® Plus) test; at 6 months, they had a cervical smear for cytology and p16/Ki-67 (CINtec® Plus) test only.

    Results Regression of cytopathological findings at 3 months, were observed in 77 out of 108 patients (71.3 %) in the SAM gel arm, whereas a similar finding was seen only in 27 out of 108 (25.0 %) in the control arm. The combination of regression and progression of cytopathological findings was in favor of patients treated with SAM gel at 3 months in the low risk and in the high-risk group and sustained at 6 months.

    Conclusions SAM vaginal gel enhances regression with a significantly decreased progression rate (6.5 %) compared to the strategy of ‘watchful waiting’ (18.5 %) over a period of 3 months in cytopathological findings, thus offering an active management to prevent cervical cancer.


     

    Interessenkonflikt

    Pedro-Antonio Regidor is als Medical Director Exeltis Europe Angestellter der Firma Exeltis Healthcare. Manuela Sailer und Anna Müller sind Angestellte der Firma Exeltis Healthcare. Alle anderen Autoren haben erklärt, dass kein Interessenkonflikt besteht.

    Publication History

    Article published online:
    07 October 2020

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