A prospective French multicentric study (phase I clinical trial) illustrated a noteworthy enhancement in gynecologic, digestive symptoms, and quality of life (QOL) for individuals suffering from rectosigmoid deep infiltrating endometriosis using transrectal high-intensity focused ultrasound (TR-HIFU). Investigators sought to establish the viability of utilizing TR-HIFU for treating endometriosis.

A total of 60 volunteers with rectal involvement participated in the study. Patients completed questionnaires on gynecologic and intestinal symptoms, as well as on quality of life using MOS-SF36 scores before treatment and at one, three, and six months post-treatment. As part of the safety evaluation, preoperative magnetic resonance imaging (MRI) was conducted, and post-intervention MRI was performed on the first day to prove the absence of complications. Additionally, at the six-month mark, both MRI and sonography were utilized to evaluate the progression of the endometrial lesion.

The rectal nodule had a mean volume of 3.0 cc. For seventy percent of the individuals, the procedures were conducted under general anesthesia, with a mean treatment duration of 35 minutes. Fifty-five subjects were discharged on the first day. The overall complication rate was 53%, but only 3.3% of patients (n= 2) experienced a postoperative type 2 complication according to the Clavien classification. No fistula was noted.

Among the 60 people observed at one, three, and six months, a notable enhancement in gynecologic, digestive, and quality of life aspects was evident. Imaging at the six-month mark demonstrated a significant 27% decline in volume. TR-HIFU treatment for rectal endometriosis, as demonstrated by a minimal number of adverse events, remarkably improved gynecologic and digestive symptoms, and the quality of life for patients. Hence, it appears to be a compelling minimally invasive substitute to conventional surgical procedures.