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. The primary objective of this clinical investigation is to evaluate the safety of the HIFU treatment of rectal endometriosis with Focal One® HIFU device.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
HIFU Treatment of rectal endometriosis
CHU de Angers
Angers, France
Clinique Tivoli-Ducos
Bordeaux, France
Hôpital BICETRE
Le Kremlin-Bicêtre, France
Clinique de Gynécologie
Lille, France
Hopital de la Croix Rousse
Lyon, France
Evaluate the tolerance of rectal endometriosis treatment with HIFU
The tolerance of the treatment will be evaluated by the analysis of adverse events occurrence at 6 months post-HIFU treatment
Time frame: 6 months
Evaluation of the gynecological symptoms evolution of patients after HIFU treatment
EVA symptom Questionnaires
Time frame: at 1 month, 3 months and 6 months post-intervention
Evaluation of the of quality of life evolution of patients after HIFU treatment
Quality of life questionnaire : MOS- SF-36
Time frame: at 1 month, 3 months and 6 months post-intervention,
Evaluation of the evolution of the nodule's volume
The pre- and post-treatment comparison of the volume of the endometriodsis nodule measurement.
Time frame: at 6 months
Evaluation of the post-intervention analgesic treatment
The level of medication during the fisrt 10 days post treatment will be studied by analysing the data collected in patient book.
Time frame: during the fisrt 10 days post treatment.
Evaluation of the digestive symptoms evolution of patients after HIFU treatment
Wexner
Time frame: at 1 month, 3 months and 6 months post-intervention
Evaluation of the digestive symptoms evolution of patients after HIFU treatment
Kess questionnaires
Time frame: at 1 month, 3 months and 6 months post-intervention
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Evaluation of the sexual symptoms evolution of patients after HIFU treatment
SFSI questionnaire
Time frame: at 1 month, 3 months and 6 months post-intervention
Evaluation of the urinary symptoms evolution of patients after HIFU treatment
USP questionnaire
Time frame: at 1 month, 3 months and 6 months post-intervention