Medical Devices: Evidence and Research (Jun 2021)
An Open, Uncontrolled Pilot Study on 12-Week Use of VagiVital for Treatment of Vulvovaginal Atrophy in Breast Cancer Patients Undergoing Adjuvant Aromatase-Inhibitor Therapy
Abstract
Aino Fianu Jonasson,1 Mikael Åstrom2 1Department of Clinical Sciences, Intervention, and Technology, Division of Obstetrics and Gynaecology, Karolinska Institute, Stockholm, Sweden; 2StatCons, Malmö, SwedenCorrespondence: Aino Fianu JonassonDepartment of Clinical Science, Intervention and Technology Division of Obstetrics and Gynecology, Karolinska Institute, Stockholm, 171 77, SwedenTel +46-70-483-6028Email [email protected]: This pilot study assessed the efficacy of 12 weeks of daily treatment with a vaginal gel based on a water-based cellulose gel in reducing the severity of moderate–severe symptoms of vulvovaginal atrophy (VVA) and followed adverse events in female breast cancer patients undergoing treatment with adjuvant aromatase- inhibitor therapy.Methods: In this open, uncontrolled pilot study, the efficacy and safety of the gel during a treatment period of 12 weeks (daily 1× 1 mL) were evaluated (n=28). The gel is made of water and hypromellose, a hydropropylmetyl cellulose, which works by coating the vagina, and was developed to treat moderate–severe symptoms of VVA. The primary efficacy variable was the most bothersome symptom (MBS; among vulvovaginal irritation and itching, vaginal dryness, dysuria, or dyspareunia) self-identified at baseline on a four-point scale.Results: A total of 28 patients fulfilled all entry criteria and had data available after the start of treatment. Treatment with the gel reduced MBS scores from baseline (n=28, mean 2.71) to week 12 (n=27, mean 1.33, mean reduction 1.37; p=0), and reduced the overall total scores for VVA symptoms from a mean of 5.39 at baseline to 2.25 at week 12 (p=0). Eleven subjects (39%) reported 19 AEs.Conclusion: A 12-week treatment with the gel significantly reduced the severity of MBSs and VVA symptoms, improved quality of life, and was safe to use in women with breast cancer undergoing adjuvant aromatase-inhibitor therapy. In view of the beneficial effects of nonhormonal treatments, for cancer patients in particular, the water-based cellulose gel VagiVital is a suitable candidate for first-choice treatment of VVA symptoms in breast cancer patients and in women predisposed to cancer.Keywords: vulvovaginal atrophy, MBS, nonhormonal therapy, dyspareunia, vaginal dryness, adjuvant AI therapy, breast cancer
