Transrectal High-Intensity Focused Ultrasound for the Management of Rectosigmoid DEEP Infiltrating Endometriosis

Abstract

<h3>Study Objective</h3> Demonstrate the feasibility of Trans Rectal High intensity focused ultrasound (HIFU) treatment in patients presenting rectosigmoid endometriosis <h3>Design</h3> Phase I, non-controlled, prospective monocentric clinical study <h3>Setting</h3> Patients filled questionnaires on gynecologic and intestinal symptoms, and on quality of life (MOS-SF36 score, EHP-5) before and at one, three and six months after treatment. <h3>Patients or Participants</h3> patients older than 25 years, who presented a symptomatic single rectosigmoid location and after failure of hormonal therapy. All lesions were assessed using transvaginal sonography and MRI. <h3>Interventions</h3> Trans Rectal HIFU treatment Using the FocalOne Probe. <h3>Measurements and Main Results</h3> Twenty-three patients were included between September 2015 and October 2018. All the lesions were visualized. Twenty lesions were treated ("feasibility rate": 87.0%): thirteen entirely and seven partially. The mean duration of the procedure was 55.6 minutes. We observed a significant improvement in visual analogic scales at six month for dysmenorrhea (-3.6, p=0.004), dyspareunia (-2.4, p=0.006), diarrhea (-3.0, p=0.006), constipation (-3, p=0.002), dyschezia (-3.2, p=0.003), false urges to defecate (-3.3, p=0.007), posterior pelvic pain (-3.8, p=0.002), and asthenia (-4.3, p=0.002).There was also a significant improvement of the MOS-SF36 with an increase of both Physical Composite Score (+9.3%, p=0.002) and Mental Composite Score (+10.9%, p=0.017) at six months. No major complications occurred during and after the procedure. <h3>Conclusion</h3> HIFU therapy for rectosigmoid location is feasible. It could be an interesting minimally invasive alternative to surgery for the treatment of rectosigmoid endometriosis. A prospective multicentric study is presently performed in France to confirm these preliminary results.