Design: prospective multicentric studies

Setting: patients with rectal endometriosis with failure of medical treatment. Hifu treatment is proposed as an alternative to radical robotic or laparoscopic surgery.

Patients or Participants: 140 patients with symptomatic rectal endometriosis have been allready included in 3 prospectives studies : feasibility study (20 patients - published in USOG revue), safety study (60 patients - published in Human reproduction revue) and a double blinded treatment vs SHAM efficacy study (60 patients - 9 endometriosis reference centers in France, datas available in june 2024)

Interventions: Robotic HIFU treatment of rectal endometriosis is an office procedure. We are using the FocalOne probe , FDA approved for prostate cancer. It is a transrectal approach performed under spinal anesthesia. The mean duration of the procedure is 35 minutes.

Measurements and Main Results: We demonstrated at 1, 3 and 6 months, that all gynaecologic, digestive and general symptoms, as well as health status, had significantly improved. Using the Clavien–Dindo classification, we listed 56.7% Grade I events, 3.4% Grade II events, and no events Grade III or higher. The evolution of the nodule was also significant (p<0.001) with a 28% decrease in volume.

Conclusion: HIFU treatment enables significant reduction in the risk of postoperative complications and an improvement of short term postoperative symptoms and quality of life. HIFU might be an alternative to surgical treatment for suitable patients. Long-term complications and relapse risks require further research.