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NCT Number: NCT05755958

Evaluation of the Efficacy of HIFU Treatment on Rectal Endometriosis Symptoms.

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Privé de Provence, Aix-en-Provence, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HIFU treatment in rectal Endometriosis

Device

HIFU treatment of rectal endometriosis

SHAM HIFU procedure

Device

SHAM HIFU procedure

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

EDAP TMS S.A.

Industry

Registry information

Official study 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.

Acronym: ENDO-HIFU-R2

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Mar 6, 2023
Registry last updated
Jun 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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