
PROBLEM STATEMENT
Heavy menstrual bleeding (HMB) is a common symptom of conditions leading to abnormal uterine bleeding (AUB). Several non-invasive treatments have been developed, but they still struggle with lower efficacy than surgical treatments. The aim of our study was to evaluate the efficacy and safety of non-ablative thermal laser treatment of the endometrium for the treatment of heavy menstrual bleeding in perimenopause.
METHODS
Placebo-controlled study of perimenopausal women with HMB randomized to either the active group of patients treated with a 1064 nm Nd:YAG laser non-ablative mode (10 W, 90 Hz, 0.6 ms) or the placebo group receiving blinded treatment. An optical fiber (Radial Emission fiber 600, id Consulting, Switzerland) was used for intrauterine treatment. All patients were followed for 6 months. The primary efficacy endpoint was the absolute change in menstrual bleeding from baseline to 6 months after treatment, measuring the weight of sanitary pads. In addition, endometrial thickness was measured by transvaginal ultrasonography. Safety outcomes included the frequency and characteristics of adverse events (AEs).
RESULTS
Preliminary screening included 6 perimenopausal women aged 44 to 52 years who had HMB. Two patients were excluded. In two patients in the active group, blood loss decreased from 128-200 g at baseline to 20-50 g after 1 month and remained below 50 g throughout 6 months. Endometrial thickness in the luteal phase had decreased to less than 5 mm in both patients 3-6 months after treatment. Two patients in the control group had a pad weight 150-200 g at baseline and reported an improvement in bleeding 1 month after treatment, but returned back to baseline 2 months after treatment. Endometrial thickness in the luteal phase averaged 8-13 mm. Monitored AEs included abdominal pain and light bleeding, which occurred transitionally and lasted on an average of 2 days.
CONCLUSION
Our results suggest that non-ablative thermal Nd:YAG laser treatment of the endometrium is a potential new treatment alternative for patients with heavy perimenopause bleeding.
Disclosure of Interest: None