Safety and performance of photobiomodulation delivered by vaginal probe in patients with genitourinary syndrome of menopause.

OBJECTIVE

Genitourinary syndrome of menopause (GSM) has a negative impact on quality of life. Treatments for GSM are largely hormonal, yet some patients remain symptomatic after recommended treatments. Photobiomodulation therapy (PBMT) is a promising non-hormonal technique.

METHOD: In this prospective, first-in-human, medical device safety study, postmenopausal patients with pelvic pain due to vaginal atrophy after failure of non-invasive therapies for >3 months were recruited. Exclusion criteria included pelvic pain of physical and/or psychological origin, treatment for cancer or immunosuppression. Patients received six weekly PBMT sessions using the MILTA GYNECO vaginal probe (PHYSIOQUANTA). The primary outcome was device safety, according to patient-reported adverse events. Secondary outcomes were vaginal mucosal health (vaginal health index [VHI]), pain (0-10 visual analog scale), vaginal flora and patient satisfaction (Patient Global Impression of Change [PGI-C]).

RESULTS

Twenty-five patients were recruited and analyzed, with an average age of 58.7 years. In total, 148 adverse events were declared, of which 146 were minor (grade I) and most were for heat sensation (89.2%). Significant improvements were found in pain during intercourse (7.65 [±1.95] before versus 3.89 [±2.44] after, p < 0.0001) and in vaginal health according to the VHI score (12.68 [±4.20] before versus 17.63 [±4.35] after, p < 0.0001). According to the PGI-C score, most patients rated their condition as improved.

CONCLUSION

Even when applying a broad definition for adverse events, these preliminary data suggested that PBMT using the MILTA GYNECO vaginal probe was safe, with high patient satisfaction. The next step is to assess the efficacity of the medical device in a randomized trial.