Intravaginal medical device a promising standalone treatment for nonspecific vaginitis

In women with nonspecific vaginitis, treatment with a medical device that uses vaginal ovules not only helps alleviate symptoms but also works to restore the normal pH and reduce signs of vaginal inflammation, as reported in a study.

In a cohort of 47 women with symptomatic vulvovaginitis either of noninfectious cause or caused by aerobic bacteria who were treated with the medical device, a significantly higher proportion did vs did not experience improvements in vaginal symptoms (72.34 percent vs 27.66 percent without any significant improvement; p<0.001). [Clin Ther 2023;doi:10.1016/j.clinthera.2023.06.023]

Specifically, substantial reductions in leukorrhea (p<0.001), pruritus (p<0.05), burn (p<0.05), rash (p<0.05), pain (p<0.001), malodour (p<0.05), dysuria (p<0.05), and dyspareunia (p<0.001) were observed over 90 days.

“An important aspect of treatment is that it reduces the symptoms of vaginitis after 30 days. Thus, for nine patients (19.15 percent) who were treated, the medical device had a beneficial effect on vaginal symptoms score (p<0.05) measured at 30 days. This improvement in vaginal symptoms score is much more evident at 60 days when 25 patients (53.19 percent) had an improvement in symptoms (p<0.001),” the investigators explained.

Apart from the mentioned improvements, vaginal pH values returned to normal by the end of the study for the nine women with abnormal pH at baseline. Favourable changes were also seen in vaginal discharge as well as in inflammatory and parabasal epithelial cells in the vagina smears.

In terms of safety, four women had mild, grade 1 vaginal infections with E coli (n=2) or group B Streptococcus (n=2), which were resolved over time with oral antibiotics. No treatment-related adverse events were reported at the end of study.

Most of the women (95.74 percent) said they were satisfied with their treatment, with only two reporting neutrality in terms of satisfaction.

The treatment protocol with the medical device consisted of one ovule per day inserted intravaginally for 15 days. All women were followed up for 3 months.

Of the women included in the study, 36 (76.6 percent) were of reproductive age, nine (19.15 percent) were in menopause, and 44 (93.62 percent) were sexually active. There were 20 women (42.55 percent) who smoked and 32 (68.09 percent) who were physically active.

Multiple benefits

The medical device is formulated as homogeneous ovules, with each ovule weighing 2 g. It is composed of three topical substances (hexylresorcinol 2 mg, vegetable collagen 15 mg, and bismuth subgallate 100 mg) and four phytotherapeutic extracts (Calendula officinalis 10 mg, Hydrastis canadensis 10 mg, Thymus vulgaris 10 mg, and Curcuma longa 10 mg).

The composition of the medical device is said to provide multiple benefits. For one, the insoluble bismuth subgallate with a low bioavailability can create a physical barrier over the affected area of the vaginal mucosa and, thus, prevent oxygen and pathogens to come in contact with the affected area, the investigators pointed out. “In this way, it creates the premises that allow the damaged tissue to heal naturally.”

On the other hand, “[t]he role of exogenous collagen is to be a sacrificial substrate to reduce excess matrix metalloproteinases that delay wound healing. The phytotherapeutic extracts and hexylresorcinol are used as preservatives to prevent contamination with microorganisms,” they added.

Despite the presence of limitations, including the absence of a control group, short follow-up duration, and heterogenicity of the sample population, the present study suggests that the intravaginal medical device can be used a standalone treatment in symptomatic, nonspecific vaginitis, according to the investigators.

“The medical device is considered a safe and effective alternative to alleviate specific signs and symptoms of atrophic vaginitis (eg, dysuria, dyspareunia, and vaginal inflammation) in postmenopausal women, especially when hormonotherapy is not recommended,” they said.

A study wherein the clinical efficacy and safety of the device in microlesion repair and postoperative care in patients undergoing local excision of cervical lesions is in the works, the investigators shared. They also called for additional studies to validate the antibiotic boosting effect of the device in patients with mixed aerobic infections requiring anti-infectious treatment regimens and the corresponding tolerability profile during pregnancy.