Doubled Blind Evaluation of the Efficacy of High Intensity Focused Ultrasound (HIFU) Treatment on Symptoms in Patients Treated for Rectal Endometriosis Compared to Sham.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Endometriosis
- Sponsor
- EDAP TMS S.A.
- Enrollment
- 60
- Locations
- 9
- Primary Endpoint
- Comparison of the evolution in the level of acute pelvic pain compared to the sham intervention group.
- Status
- Active, not recruiting
- Last Updated
- 11 months ago
Overview
Brief 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.
Investigators
Eligibility Criteria
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,
Outcomes
Primary Outcomes
Comparison of the evolution in the level of acute pelvic pain compared to the sham intervention group.
Time Frame: 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.
Secondary Outcomes
- Overall recovery time evaluation(3 months)
- Evaluation of sexual fonction(1 and 3 months)
- Post treatment medication rate(10 days)
- Post treatment pain rate(10 days)
- Adverse Events occurrence and comparison between the two groups(3 months)
- Evaluation of constipation(1 and 3 months)
- Quality of life evoluation(1 and 3 months)
- Evaluation of anal continence(1 and 3 months)
- Evaluation of urinary symptoms(1 and 3 months)
- Symptoms evolution evaluation(1 and 3 months)
- Volume lesion evaluation(3 months)