Clinical Evaluation of the Efficacy and Safety of a Medical Vaginal Device Containing Rigenase for the Treatment of Vaginosis: A Randomized Study

Rosa Papa, Maria Grazia Troncone, Francesco Altruda, Valentina Rullo, Giorgio Saponati


Background: Vaginitis is an inflammatory process involving the vagina, expanding often to the contiguous anatomical structures (cervix and vulva). From an etiological point of view, there are mainly two types of vaginitis: specific vaginitis (due to pathogenic microorganisms) and non-specific vaginitis (also defined vaginosis), usually caused by an alteration (disruption) of the normal vaginal microflora, usually represented by the presence of Lactobacilli due to opportunist bacteria proliferation. Whereby, the first line therapeutic approach for vaginosis (which is frequently subject to self-medication) should be focused on rebalancing the flora and not on antimicrobials, reserving the latter to persistent cases that are properly characterized by appropriate microbiological tests. A new medical device is available in different formulations for the local treatment of vaginitis and, in addition, of irritative-dystrophic states of the vaginal area.

Methods: In a randomized (kind of the device used), parallel-groups, single-centered, uncontrolled design clinical study, 75 Caucasian female outpatients suffering from vaginosis were treated with the new vaginal medical device (cream, vaginal suppository, vaginal solution, gel, and foam; n = 15 in each group) for 6 days. Before (V1) and at the end of the treatment period (V2), the presence and intensity of pain, burning, itch, dry vagina sense, dyspareunia, dysuria, vaginal discharge, and vulvovaginal erythema were checked. Signs and symptoms were quantified according to the scale: absent = 0, mild = 1, moderate = 2 and severe = 3. The overall symptoms were summarized according to the total symptoms score (TSS), defined as the sum of scores of all signs and symptoms.

Results: The analysis conducted on the TSS for the intention-to-treat (ITT) population showed a statistically significant improvement of symptoms in all treatment groups (P < 0.001), with an average reduction of the initial TSS similar in the different groups and ranging between 73% and 80% (with a V2/V1 ratio of 0.27 and 0.20, respectively). No clinically significant differences were observed between the different preparation used. At the starting visit, the most common signs and symptoms were burning, leukorrhea and vulvo-vaginal erythema, each present in 62/75 patients (82.7). All signs and symptoms were significantly regressed or disappeared at the final visit in most of the cases; the improvement score was statistically significant (P < 0.05) when analyzing the total of patients, and often it resulted in a significant difference in the individual treatment groups as well, except when only a few patients had a sign/symptom at baseline. None of patients discontinued the application of the device before the schedule period. Adverse events were detected in none of the patients studied.

Conclusions: The medical device in vaginal formulations appear to be effective and safe for the local treatment of moderate-mild inflammatory-dystrophic gynecological diseases.

J Clin Gynecol Obstet. 2017;6(1):6-11


Vaginitis; Bacterial vaginosis; Vaginosis treatment; Rigenase®

Full Text: HTML PDF

Browse  Journals  


Journal of Clinical Medicine Research

Journal of Endocrinology and Metabolism

Journal of Clinical Gynecology and Obstetrics

World Journal of Oncology

Gastroenterology Research

Journal of Hematology

Journal of Medical Cases

Journal of Current Surgery

Clinical Infection and Immunity

Cardiology Research

World Journal of Nephrology and Urology

Cellular and Molecular Medicine Research

Journal of Neurology Research

International Journal of Clinical Pediatrics






Journal of Clinical Gynecology & Obstetrics, quarterly, ISSN 1927-1271 (print), 1927-128X (online), published by Elmer Press Inc.                     
The content of this site is intended for health care professionals.
This is an open-access journal, the authors retain the copyright, the journal is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International
License, which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Creative Commons Attribution license (Attribution-NonCommercial 4.0 International CC-BY-NC 4.0)

This journal follows the International Committee of Medical Journal Editors (ICMJE) recommendations for manuscripts submitted to biomedical journals,
the Committee on Publication Ethics (COPE) guidelines, and the Principles of Transparency and Best Practice in Scholarly Publishing.

website:   editorial contact:
Address: 9225 Leslie Street, Suite 201, Richmond Hill, Ontario, L4B 3H6, Canada

© Elmer Press Inc. All Rights Reserved.

Disclaimer: The views and opinions expressed in the published articles are those of the authors and do not necessarily reflect the views or opinions of the editors and Elmer Press Inc. This website is provided for medical research and informational purposes only and does not constitute any medical advice or professional services. The information provided in this journal should not be used for diagnosis and treatment, those seeking medical advice should always consult with a licensed physician.