PURPOSE: To determine whether the phase of menstrual cycle at the time of MR-guided focused ultrasound surgery (MRgFUS) treatment for uterine leiomyomas affects treatment outcome. METHODS: We enrolled all patients participating in a prospective phase III clinical trial from our center who completed 6 months of clinical and imaging follow-up. Patients with irregular cycles and those on oral contraceptives were excluded. Data prospectively documenting the date of the last menstrual period (LMP) at the time of treatment, length and duration of cycle, and raw symptom severity score (SSS) from the Uterine Fibroid Symptom and Quality of Life questionnaire, at baseline and 6 months were collected. Proliferative phase patients were determined retrospectively as those who were treated within less than 14 days from LMP; secretory phase patients were classified as those who were treated greater than 14 days from LMP. RESULTS: A total of 58 patients were enrolled. There was no significant difference in the mean SSS at baseline and mean SSS at 6 months between patients treated in the proliferative versus secretory phase of the cycle. No significant difference in the SSS change from baseline to 6 months was seen between the two groups. CONCLUSIONS: Menstrual cycle phase does not influence MRgFUS treatment outcome. Symptomatic improvement occurs with treatment during either phase of the menstrual cycle. Thus, the scheduling of MRgFUS treatment need not be based upon the phase of the menstrual cycle.
PURPOSE: To determine whether the phase of menstrual cycle at the time of MR-guided focused ultrasound surgery (MRgFUS) treatment for uterine leiomyomas affects treatment outcome. METHODS: We enrolled all patients participating in a prospective phase III clinical trial from our center who completed 6 months of clinical and imaging follow-up. Patients with irregular cycles and those on oral contraceptives were excluded. Data prospectively documenting the date of the last menstrual period (LMP) at the time of treatment, length and duration of cycle, and raw symptom severity score (SSS) from the Uterine Fibroid Symptom and Quality of Life questionnaire, at baseline and 6 months were collected. Proliferative phase patients were determined retrospectively as those who were treated within less than 14 days from LMP; secretory phase patients were classified as those who were treated greater than 14 days from LMP. RESULTS: A total of 58 patients were enrolled. There was no significant difference in the mean SSS at baseline and mean SSS at 6 months between patients treated in the proliferative versus secretory phase of the cycle. No significant difference in the SSS change from baseline to 6 months was seen between the two groups. CONCLUSIONS: Menstrual cycle phase does not influence MRgFUS treatment outcome. Symptomatic improvement occurs with treatment during either phase of the menstrual cycle. Thus, the scheduling of MRgFUS treatment need not be based upon the phase of the menstrual cycle.