Evaluation of the Efficacy of HIFU Treatment on Rectal Endometriosis Symptoms. (ENDO-HIFU-R2)

• ClinicalTrials.gov Identifier: NCT05755958
• Recruitment Status: Active, not recruiting
• First Posted: March 6, 2023
• Last Update Posted: April 19, 2024
• Sponsor: EDAP TMS S.A.
• Information provided by (Responsible Party): EDAP TMS S.A.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Endometriosis	Device: HIFU treatment in rectal Endometriosis; Device: SHAM HIFU procedure	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Doubled Blind Evaluation of the Efficacy of High Intensity Focused Ultrasound (HIFU) Treatment on Symptoms in Patients Treated for Rectal Endometriosis Compared to Sham.
• Actual Study Start Date: February 3, 2023
• Actual Primary Completion Date: January 23, 2024
• Estimated Study Completion Date: December 31, 2024

Arms and Interventions

Arm	Intervention/treatment
Sham Comparator: HIFU SHAM; The patient placed in the right lateral decubitus position under general anesthesia or spinal anesthesia on the operating table. An endorectal probe is inserted in the patient's rectum. The probe includes an imaging transducer to visualize the endometriosis lesions and locate areas to be treated and an ultrasound therapy transducer to administer the HIFU treatment. After identification of the treatment area, HIFU shots will not be delivered on the lesion to be treated in a blinded manner. Patients randomized to this arm will received exactly the same procedure as patients in the HIFU group with the exception of the HIFU shots.	Device: SHAM HIFU procedure; SHAM HIFU procedure
Active Comparator: HIFU TREATMENT; The patient placed in the right lateral decubitus position under general anesthesia or spinal anesthesia on the operating table. An endorectal probe is inserted in the patient's rectum. The probe includes an imaging transducer to visualize the endometriosis lesions and locate areas to be treated and an ultrasound therapy transducer to administer the HIFU treatment. After identification of the treatment area, HIFU shots will be delivered on the lesion to be treated in a blinded maner.	Device: HIFU treatment in rectal Endometriosis; HIFU treatment of rectal endometriosis

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. Adverse Events occurrence and comparison between the two groups [ Time Frame: 3 months ]
   Occurrence of adverse events during the 3 months of post-intervention follow-up will be evaluated in each group.
2. Symptoms evolution evaluation [ Time Frame: 1 and 3 months ]

   The Visual Analog Scale (VAS) symptoms questionnaire to assess gynecologic, digestive, urinary and general symptoms though 15 different visual scales ranging from 0 (representing no symptom) to 10 (representing the worst patient feeling).

   Symptoms level will be collected before treatment and at 1 and 3 months after treatment. The symptoms' evolution in the HIFU group will be compared to those in the sham intervention group.

3. Evaluation of anal continence [ Time Frame: 1 and 3 months ]

   The Wexner total score ranges from 0 to 23 points corresponding to the sum of the 6 questions. Anal incontinence is considered as mild for a total score from 0 to 4, moderate when ranging from 5 to 9, important from 10 to 16, and considered as severe if equal to 16 or higher.

   Symptoms level will be collected before treatment and at 1 and 3 months after treatment. The symptoms' evolution in the HIFU group will be compared to those in the sham intervention group.

4. Evaluation of constipation [ Time Frame: 1 and 3 months ]

   The KESS (Knowles-Eccersley-Scott Symptom) question is composed of the sum of 11 questions evaluating constipation. The total score ranges from 0 to 39 points corresponding to a total constipation status. Constipation is generally defined as a score above 10.

   Symptoms level will be collected before treatment and at 1 and 3 months after treatment. The symptoms' evolution in the HIFU group will be compared to those in the sham intervention group.

5. Evaluation of urinary symptoms [ Time Frame: 1 and 3 months ]

   USP (Urinary Symptoms Profile) is a questionnaire that assesses urinary symptoms. It includes 13 questions grouped in 3 domains:

   • Incontinence ranging from 0 to 9
   • Overactive bladder ranging from 0 to 21
   • Dysuria ranging from 0 to 9

   The USP total score is the sum of all the 13 answers and ranges from 0 to 39 points, where 39 corresponds to the worst situation. Urinary dysfunction is generally defined as a score above 10.

   Symptoms level will be collected before treatment and at 1 and 3 months after treatment. The symptoms' evolution in the HIFU group will be compared to those in the sham intervention group.

6. Evaluation of sexual fonction [ Time Frame: 1 and 3 months ]

   FSFI (Female Sexual Function Index scoring) is a validated questionnaire, including 19 items, which assesses different domains of sexual function (desire, arousal, lubrication, orgasm, satisfaction, and pain) in addition to providing an overall score regarding sexual function. FSFI total score ranges from 2 (worst situation) to 36 (best situation).

   Symptoms level will be collected before treatment and at 1 and 3 months after treatment. The symptoms' evolution in the HIFU group will be compared to those in the sham intervention group.

7. Quality of life evoluation [ Time Frame: 1 and 3 months ]

   The questionnaire for the Quality of life evaluation is MOS-SF-36 (Medical Outcomes Study Short Form 36 item Health survey).

   The MOS-SF-36 questionnaire consists of 36 questions which are divided into 8 different domains. Each domain is represented by the average of several questions (after recoding). Two scores, physical and mental, are then calculated. The maximum value of 100 corresponds to an optimal quality of life as described by the patient and zero the worst situation.

   Quality of life will be collected before treatment and at 1 and 3 months after treatment. The quality of life evolution in the HIFU group will be compared to those in the sham intervention group.

8. Volume lesion evaluation [ Time Frame: 3 months ]

   The volume of endometriosis nodule will be evaluated on MRI, before treatment and at 3 months after treatment.

   (blinded evaluation of the treatment groups). The volume variation observed in the HIFU group will be compared with those observed in the Sham Intervention group.

9. Post treatment medication rate [ Time Frame: 10 days ]
   The level of post-treatment medication during the first 10 days will be collected in the patient diary. The level of post-treatment medication in HIFU group will be compared to those in the sham intervention group.
10. Post treatment pain rate [ Time Frame: 10 days ]
    The level of pain will be evaluated by daily self-evaluation by the patients;rom 0 (best situation) to 10 (worst situation), and collected on the daily diary during the first 10 days post-intervention. The pain level in HIFU group will be compared to the sham intervention group.
11. Overall recovery time evaluation [ Time Frame: 3 months ]

    The overall recovery time will be evaluated by the patients on the patient diary.

    The overall recovery time observed in the HIFU group will be compared to those observed in the Sham intervention group.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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,
• 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

Contacts and Locations

Locations

France

Hopital Privé de Provence

Aix-en-Provence, France, 13080

CHU de Angers

Angers, France, 49000

Clinique Tivoli-Ducos

Bordeaux, France, 33000

Chu Estaing

Clermont-Ferrand, France, 63000

Hôpital du Kremlin Bicetre

Le Kremlin-Bicêtre, France, 94270

Hôpital privé Le Bois

Lille, France, 59000

Hopital de la Croix Rousse

Lyon, France, 69004

Hôpital COCHIN

Paris, France, 75014

CHU Strasbourg

Strasbourg, France, 67200

Sponsors and Collaborators

EDAP TMS S.A.

Investigators

• Principal Investigator: Gil Dubernard, Pr; EDAP TMS

More Information

• Responsible Party: EDAP TMS S.A.
• ClinicalTrials.gov Identifier: NCT05755958
• Other Study ID Numbers: HIFU/F/21.12
• First Posted: March 6, 2023
• Last Update Posted: April 19, 2024
• Last Verified: May 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by EDAP TMS S.A.:

Rectal Endometriosis; HIFU; FocalOne; High Intensity Focused Ultrasound

Additional relevant MeSH terms:

Endometriosis; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases