HIFU treatment in rectal EndometriosisSHAM HIFU procedure
HIFU treatment in rectal Endometriosis: HIFU treatment of rectal endometriosis
SHAM HIFU procedure: SHAM HIFU procedure
Study summary
Rectal endometriosis (RE) induces lesions associated with painful symptoms that can alter quality of life. High Intensity Focused Ultrasound (HIFU) is a non-invasive ablative procedure using a high-intensity ultrasound probe to induce tissue devitalization using acoustic cavitation and thermal ablation.
Focal One® is a transrectal HIFU device, which is validated to treat prostatic cancer.
In this comparative, randomized, double blind study , the primary objective is to evaluate the efficacy of the HIFU treatment of rectal endometriosis with Focal One® HIFU device on the Acute Pelvic Pain 3 months after HIFU treatment, in comparison to a Sham group.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Patient 18 years of age or older,
* Rectal endometriosis on preoperative imaging with no other digestive location,
* Symptomatic patient (Acute pelvic pain \> 3), in failure of drug treatment,
* Endometriotic lesion visible on ultrasound and confirmed on MRI,
* Centralized MRI, reviewed and validated by the MRI review committee,
* No current pregnancy and no pregnancy plan during the study period,
* Patient agreeing not to change her hormonal treatment throughout the study period,
* Patient accepting the constraints of follow-up defined in the framework of the study,
* Patient affiliated to French health insurance.
Exclusion Criteria:
* Ongoing urogenital infection,
* Anorectal anatomy incompatible with HIFU treatment,
* Overall pain level considered intolerable by the patient and making a potential 3-months delay management impossible,
* History of segmental rectal resection or discoid resection,
* Patient with an implant located less than 1 cm from the treatment area,
* Inflammatory disease of the colon,
* Allergy to latex,
* No scheduled endometriosis procedures during study follow-up,
* Treatment of endometriosis in the context of pregnancy desire for which a 3-month delay is not appropriate
* Patient with contraindications to MRI,
* Patient who has already received HIFU treatment for a rectal endometriotic lesion,
* Patient who does not speak or read French,
* Patient deprived of liberty following a judicial or administrative decision,
* Patient in labor or nursing,
* Patient under guardianship or curatorship
Primary outcome measure(s)
Comparison of the evolution in the level of acute pelvic pain compared to the sham intervention group. — 3 months The efficacy of HIFU treatment will be assessed by comparing the evolution in the level of acute pelvic pain assessed by Visual Analog Scale (VAS), ranging from 0 (best situation) to 10 (worst situation) at 3 months, to the pre-treatment pain level. The evolution in the HIFU group will be compared to those in the sham intervention group.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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