دورية أكاديمية
POLARIS: efficacy and safety of a vaginal medical device in recurrent bacterial vaginosis-a multicenter, open-label, non-controlled, study with 10 months of follow-up.
| العنوان: | POLARIS: efficacy and safety of a vaginal medical device in recurrent bacterial vaginosis-a multicenter, open-label, non-controlled, study with 10 months of follow-up. |
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| المؤلفون: | Murina F; Lower Genital Tract Disease Unit, V. Buzzi Hospital-University of Milan, Italy.; Postgraduate School of Gynecology and Obstetrics, University of Milan, Milano, Italy., Inghirami P; AIED Centre, Rome, Italy., Biriș M; Clinica Medicală Biriș Marius, Timișoara, România., Sîrbu D; Clinica Medicală Dr. Sîrbu Daniela, Timișoara, România., Barattini DF; Opera CRO, a TIGERMED Group company, Timișoara, România., Ardolino LI; Italfarmaco SpA, Cinisello Balsamo - Milan, Italy., Mangrella M; Italfarmaco SpA, Cinisello Balsamo - Milan, Italy., Casolati E; Private Practice of Obstetrics and Gynecology, Milan, Italy., Roșu SM; University of Medicine and Pharmacy Victor Babeș, Timișoara, România., Crișan C; Clinica Medicală Dr. Crișan Ciprian, Timișoara, România. |
| المصدر: | The Journal of international medical research [J Int Med Res] 2024 May; Vol. 52 (5), pp. 3000605241239021. |
| نوع المنشور: | Journal Article; Multicenter Study; Observational Study |
| اللغة: | English |
| بيانات الدورية: | Publisher: Sage Publications Country of Publication: England NLM ID: 0346411 Publication Model: Print Cited Medium: Internet ISSN: 1473-2300 (Electronic) Linking ISSN: 03000605 NLM ISO Abbreviation: J Int Med Res Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: Nov. 2012- : London : Sage Publications Original Publication: Northampton, Eng., Cambridge Medical Publications ltd. |
| مواضيع طبية MeSH: | Vaginosis, Bacterial*/drug therapy , Vaginosis, Bacterial*/microbiology , Recurrence* , Vagina*/microbiology, Humans ; Female ; Adult ; Follow-Up Studies ; Middle Aged ; Treatment Outcome ; Anti-Bacterial Agents/therapeutic use ; Anti-Bacterial Agents/administration & dosage ; Lactobacillus/isolation & purification ; Administration, Intravaginal ; Young Adult |
| مستخلص: | Objective: Recurrent bacterial vaginosis (RBV) after antibiotic treatment has relapse rates of 35% within 3 months and 60% within 12 months. A medical device containing polycarbophil, lauryl glucoside, and glycerides (PLGG) inhibits bacterial growth and has mucoadhesive properties. This study examined the efficacy of the device in women with RBV. Methods: This post-market clinical follow-up study comprised two phases. The first phase was an interventional, open-label, non-controlled, multicenter study enrolling 56 women. The second phase was an observational 10-month follow-up without treatment. Results: After three cycles of PLGG treatment, recurrence was identified in 8 of 54 evaluable patients (14.81%). A positive effect on lactobacilli in the vaginal secretions was observed in 26 of 39 patients (66.67%). Among 35 patients observed after stopping PLGG treatment, one case of RBV (2.86%) was observed after 4 months, and an additional six cases (17.14%) were observed after 10 ± 2 months. Therefore, no recurrence was evidenced in 12 subjects (34.28%) at the end of the study. Conclusion: The use of PLGG vaginal ovules in the treatment of BV reduces the rate of recurrence and apparently produces a positive effect on the vaginal microbiota. Competing Interests: Declaration of conflicting interestsFM, PI, MB, DS, SMR, and CC declare no conflict of interest. DFB is employed at Opera CRO, the Contract Research Organization that managed the study. EC is a medical consultant for Italfarmaco SpA. LIA and MM are employed at Italfarmaco SpA. |
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| فهرسة مساهمة: | Keywords: Bacterial vaginosis; Gardnerella vaginalis; Lactobacillus; biofilm; lauryl glucoside; microbiota; polycarbophil; recurrent vaginitis |
| المشرفين على المادة: | 0 (Anti-Bacterial Agents) |
| تواريخ الأحداث: | Date Created: 20240510 Date Completed: 20240510 Latest Revision: 20240610 |
| رمز التحديث: | 20240611 |
| مُعرف محوري في PubMed: | PMC11089948 |
| DOI: | 10.1177/03000605241239021 |
| PMID: | 38726878 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1473-2300 |
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| DOI: | 10.1177/03000605241239021 |