Clinical Performance and Safety of Vaginal Ovules in the Local Treatment of Nonspecific Vaginitis: A National, Multicentric Clinical Investigation

• Published in: Clinical therapeutics 2023-09, Vol.45 (9), p.873-880
• Main Authors: Toader, Daniela Oana, Olaru, Raluca Alexandra, Iliescu, Dominic-Gabriel, Petrita, Ramona, Calancea, Florentina Liliana, Petre, Izabella
• Format: Article
• Language: English
• Subjects: Aerobic bacteria; Antibiotics; Bacteria; Candidiasis; Clinical medicine; Collagen; Health services; Infections; Inflammation; Medical device; Medical devices; Medical equipment; Medical technology; Microbiomes; Microorganisms; Nonspecific vaginitis; Ovules; Population studies; Pregnancy; Signs and symptoms; Trichomoniasis; Vagina; Vaginal discharge; Vaginal microbiome; Vaginal pH; Vaginitis; Vaginosis; Vulvovaginitis
• ISSN: 0149-2918; 1879-114X
• DOI: 10.1016/j.clinthera.2023.06.023

Nonspecific vaginitis is a distinct clinical entity with particular microscopic and immunologic features. There is currently no standard of care for women with nonspecific vaginitis. The aim of our study was to assess the change in vaginal symptoms score after 3 months of treatment with an intravaginal medical device in participants with abnormal vaginal discharge and specific signs and symptoms. As secondary objectives, the study analyzed other clinical and microscopic features, such as vaginal discharge aspect, change in vaginal pH, change in vaginal microbiome, and vaginal inflammation. The study population included 47 participants with symptomatic vulvovaginitis, distinct from candidiasis, trichomoniasis, or bacterial vaginosis. The study design included 2 research sites from Romania. The treatment protocol consisted of 1 ovule per day inserted intravaginally during 15 consecutive days. The total study duration was 3 months. The intravaginal medical device had a positive impact on the vaginal symptoms score for 72.34% of the study participants. Topical administration of the ovules balanced vaginal pH values and significantly reduced signs of inflammation between study visits. This intravaginal medical device had curative effects that support its use as a stand-alone treatment in women with nonspecific vaginitis. A second clinical investigation is ongoing to evaluate the clinical efficacy of the device in postoperative care of cervical and vaginal wounds traumatic or secondary to surgical interventions. ClinicalTrials.gov identifier: NCT04735705.