Evaluating the safety of high-intensity focused ultrasound treatment for rectal endometriosis: results from a French prospective multicentre study including 60 patients.

STUDY QUESTION: Is increasing the intensity of high-intensity focused ultrasound (HIFU) by 30% in the treatment of rectal endometriosis a safe procedure? SUMMARY ANSWER: This study demonstrates the safety of a 30% increase in the intensity of HIFU in the treatment of rectal endometriosis, with no Clavien-Dindo Grade III complications overall, and namely no rectovaginal fistulae. WHAT IS KNOWN ALREADY: A feasibility study including 20 patients with rectal endometriosis demonstrated, with no severe complications, a significant improvement in digestive disorders, dysmenorrhoea, dyspareunia, and health status, although the volume of the endometriosis nodule did not appear to be reduced. STUDY DESIGN, SIZE, DURATION: A prospective multicentre cohort study was conducted between 2020 and 2022 with 60 patients with symptomatic rectal endometriosis. Following the failure of medical treatment, HIFU treatment was offered as an alternative to surgery. PARTICIPANTS/MATERIALS, SETTING, METHODS: As the main objective of this study was to examine safety, all adverse events observed during the 6 months of follow-up were analysed and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) and Clavien-Dindo classifications. Secondary objectives included evaluating the evolution of symptoms using validated questionnaires: gynaecological and digestive pain symptoms with a visual analogue scale, health status with the Medical Outcomes Study 36-item Short Form (SF-36) questionnaire, average post-operative daily pain level, and analgesic medication required in the 10 days following treatment. MRI was also performed at Day 1 to detect early complications. Finally, we performed a blinded MRI review of the evolution of the nodule at 6 months post-treatment. MAIN RESULTS AND THE ROLE OF CHANCE: The procedure was performed under spinal anaesthesia for 30% of the patients. The median duration of treatment was 32 min. Fifty-five patients left the hospital on Day 1. MRI scans performed on Day 1 did not highlight any early-onset post-operative complication. Using the Clavien-Dindo classification, we listed 56.7% Grade I events, 3.4% Grade II events, and no events Grade III or higher. At 1, 3, and 6 months, all gynaecologic, digestive and general symptoms, as well as health status, had significantly improved. The evolution of the nodule was also significant (P < 0.001) with a 28% decrease in volume. LIMITATIONS, REASONS FOR CAUTION: The main objective was safety and not effectiveness. The study was not randomized and there was no control group. WIDER IMPLICATIONS OF THE FINDINGS: HIFU treatment for rectal endometriosis results in an improvement of symptoms with low morbidity; as such, for selected patients, it could be a valuable alternative to surgical approaches following the failure of medical treatment. STUDY FUNDING/COMPETING INTEREST(S): The study was funded by the company EDAP TMS. Professors Dubernard and Rousset are consultants for EDAP TMS. Dubernard received travel support from EDAP-TMS. Dr F. Chavrier received industrial grants from EDAP-TMS. He has developed a device for generating focused ultrasonic waves with reduced treatment time. This device has been patented by EDAP-TMS. Dr Lafon received industrial grants from EDAP-TMS; he declares that EDAP-TMS provided funding directly to INSERM to support a young researcher chair in therapeutic ultrasound, which is unrelated to the current study. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov identifier NCT04494568.

Glue mesh fixation in laparoscopic sacrocolpopexy: results at 3 years' follow-up.

INTRODUCTION AND HYPOTHESIS: We assessed 3-year anatomic and functional results using synthetic glue to fix mesh in laparoscopic sacrocolpopexy. METHODS: Prospective multicenter cohort study in three academic urogynecology departments. Seventy consecutive patients with stage ≥ 3 POP-Q (Pelvic Organ Prolapse Quantification) anterior and/or apical prolapse underwent laparoscopic sacrocolpopexy using synthetic surgical glue to fix anterior and posterior meshes to the vagina. Patients were followed up at 1, 2 and 3 years. Primary outcome was anterior and apical anatomic success (POP-Q stage ≤ 1) at 3 years. Secondary outcomes comprised functional results (international quality of life and sexuality scales), mesh-related morbidity and urinary incontinence at 3 years. RESULTS: Mean age was 56.7 ± 1.2 years. Mean follow-up was 43 months. Anterior compartment anatomic success rate was 87% at 2 years (Ba, -2.4 cm; p < 0.0001) and 86.5% at 3 years (Ba, -2.3 cm; p < 0.0001); apical success was 96.3% at 2 years (C, -6.8 cm; p < 0.0001) and 97.3% at 3 years (C, -6.5 cm; p < 0.0001). All quality-of-life scores improved significantly and lastingly at 3 years: PFDI-20, PFIQ-7 and PISQ-12, respectively, p < 0.0001, p < 0.0001 and p = 0.01. There was one case of vaginal mesh exposure at 3 years (2.8%) and five of mesh shrinkage at 1 year (7.8%), none at 2 years and two at 3 years (5.4%). Urinary incontinence rate was 29.7% at 1 year, 14.8% at 2 years and 11.1% at 3 years. CONCLUSION: Vaginal mesh adhesive in laparoscopic sacrocolpopexy remained effective at 3 years, with excellent tolerance and no specific complications. Anatomic and functional results were good and enduring in terms of both anterior and apical correction.

Transrectal high-intensity focused ultrasound (HIFU) for management of rectosigmoid deep infiltrating endometriosis: results of Phase-I clinical trial.

OBJECTIVES: Deep infiltrating endometriosis (DIE) of the rectosigmoid is associated with painful symptoms. When medical treatment is ineffective, surgical resection remains the standard treatment, despite significant risk of adverse events. High-intensity focused ultrasound (HIFU) is a minimally invasive ablative procedure. Focal One® is a transrectal HIFU (TR-HIFU) device used in prostate cancer treatment. The primary objective of this study was to confirm the feasibility of treatment with TR-HIFU in patients presenting with posterior DIE with rectosigmoid involvement. We also assessed its safety and clinical efficacy in this context. METHODS: This was a non-controlled, prospective, Phase-I clinical trial in a French University Hospital which is a multidisciplinary center for management of endometriosis. Included were patients older than 25 years, without plans to conceive within 6 months, who presented with a single lesion of posterior DIE, with rectosigmoid invasion, after failure of hormonal therapy. All lesions were assessed preoperatively using transvaginal sonography and magnetic resonance imaging. Patients completed questionnaires on gynecological and intestinal symptoms (similar to a visual analog scale (VAS)), and on quality of life (Medical Outcomes Study 36-item short-form survey (SF-36) and, for the second half of patients recruited, symptom scoring system for constipation (KESS), female sexual function index (FSFI) and endometriosis health profile short-version score (EHP-5)), before, and at 1, 3 and 6 months after, TR-HIFU treatment with a Focal One real-time ultrasound-guided HIFU device. RESULTS: Twenty-three consecutive patients were included in the study between September 2015 and October 2019. All 23 lesions were visualized, giving a detection rate of 100%. Twenty lesions were treated ('feasibility rate', 87.0%): in 13 the whole lesion was treated and in seven the lesion was treated partially. The mean duration of the TR-HIFU procedure was 55.6 min. We observed a significant improvement in VAS score at 6 months, with differences relative to preoperative scores as follows, for: dysmenorrhea (-3.6, P = 0.004), dyspareunia (-2.4, P = 0.006), diarrhea (-3.0, P = 0.006), constipation (-3.0, P = 0.002), dyschezia (-3.2, P = 0.003), false urge to defecate (-3.3, P = 0.007), posterior pelvic pain (-3.8, P = 0.002) and asthenia (-3.8, P = 0.002). There was also a significant improvement in the SF-36 score, with an increase at 6 months relative to the preoperative score in both the physical component summary (+ 9.3%, P = 0.002) and mental component summary (+ 10.9%, P = 0.017). No major complications occurred during or after any procedure. CONCLUSIONS: TR-HIFU therapy for posterior DIE is feasible. If its efficacy and safety are confirmed, it could be a minimally invasive alternative to surgery for the treatment of rectosigmoid endometriosis. © 2019 Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.

[Laparoscopic sacrocolpopexy for pelvic organ prolapse: guidelines for clinical practice]. / Traitement du prolapsus génital par promontofixation laparoscopique : recommandations pour la pratique clinique.

INTRODUCTION: Open sacrocolpopexy have demonstrated its efficiency in surgical treatment of pelvic organ prolapse with an important backward on a large number of patients. Laparoscopic sacrocolpopexy reproduced the same surgical technique with reduced morbidity and may benefits from the recent development of robotic. Numerous technical variants have been developped around the original procedure but results seems not ever equivalent. Our objectives are to establish practical recommendations issues from the data of the litterature on the various technical aspects of this technique. METHODS: This work leans on an exhaustive lecture of the literature concerning meta analyses, randomized tries, registers, controlled studies and the largest non controlled studies published on the subject. Recommendations were developed by a multidisciplinary workgroup then reread and amended by an also multidisciplinary group of proofreaders (urologists, gynecologists, gastroenterologists and surgeons). The methodology follows at best the recommendations of the HAS with a scientific argument for every question (accompanied with the level of proof, NP) and the recommendations, the officers (In, B, C and agreement of experts) and validated at the end of the phase of review. RESULTS: Surgical treatment of uro-genital prolapse by abdominal route classically associated hystero and anterior vaginopexy on the sacral ligament with a synthethic mesh. There are no argument to systematically associated a posterior vaginopexy to prevent secondary rectocele (level C). The consensual indication of laparoscopic rectopexy is represented by symptomatic rectal prolapse, the anatomical and functional results of which are the best estimated (level C). The surgical treatment of rectocele, elytrocele and enterocele with a posterior vaginopexy is not well estimated (level 3). Thus, it is not possible to conclude on the results of a posterior vaginal fixation with a mesh in these indications (AP). In the absence of colpocèle, the interest brought by the posterior vaginal mesh is not established (level 3). There is no comparative studies which allows to conclude on the type and mode of fixation of the prostheses of sacrocolpopexy. We would only report the most common practices without other conclusion. The anterior mesh is usually fixed upper on the anterior part of uterus cervix and lower on the anterior vaginal wall. These fixations are most of the time made by suture and on the promontory with non absorbable suture. The great majority of the authors recommend to make a peritonisation of prostheses to limit the risk of post-operative occlusion. It is now recommended to use only 2 kind of not absorbable prostheses: type I (macroporous polypropylene) or type III (polyester) and not to use any more prostheses type II (PTFE, Silicone) (level C) because of a high rate of mesh erosion: PTFE (9 %) or Silicone (19%) (level 3). Biological prostheses are no more recommended, because of short and medium-term lower anatomical results (level B). Anatomical and functional results are not stastistically differents between laparotomy and coelioscopy (NP1) but the comparison of tong-term results between both ways is not yet established. Coelioscopy allows significant reduction of blood losses, hospital stay and return to normal activity (level 1). Furthemore, there is a higher level of post-operative complications in laparotomy (level 1). When sacrocolpopexy is indicated, coelioscopy is thus recommended (level B). During coelioscopic sacrocolpopexy, anatomical and functional result have not shown any significance difference when using or no a robotics assistance but real randomised studies does not exist (level 2). In comparison to coelioscopy, robotic seems not to improve post-operative consequences and not to decrease the rate of complications of sacrocolpopexy (level 3). Robotic assistance cannot be yet recommended when a coelioscopic sacrocolpopexy is indicated (rank B). CONCUSION: Sacrocolpopexy using not absorbable meshes allows to cure pelvic organ prolapses with very good results with few complications in terms of prothetic exposure and infection and thus is now considered as the referent prothetic surgical technique in this indication. Thus, it seems very important to establish clear recommendations on the numerous operating technical variants which developed around the original technique. © 2016 Published by Elsevier Masson SAS.

[Does hysterectomy modifies the anatomical and functional outcomes of prolapse surgery?: Clinical Practice Guidelines]. / L'hystérectomie modifie-t-elle les résultats anatomiques et fonctionnels de la cure de prolapsus ? : Recommandations pour la pratique clinique.

OBJECTIVE: Provide guidelines for clinical practice concerning hysterectomy during surgical treatment of pelvic organ prolaps, with or without mesh. METHODS: Systematically review of the literature concerning anatomical and functionnal results of uterine conservation or hysterectomie during surgical treatment of pelvic organ prolaps. RESULTS: Sacrospinous hysteropexy is as effective as vaginal hysterectomy and repair in retrospective comparative studies and in a meta-analysis with reduced operating time, blood loss and recovery time (NP2). However, in a single RCT there was a higher recurrence rate associated with sacrospinous hysteropexy compared with vaginal hysterectomy. Sacrospinous hysteropexy with mesh augmentation of the anterior compartment was as effective as hysterectomy and mesh augmentation (NP2), with no significant difference in the rate of mesh exposure between the groups (NP3). Sacral hysteropexy is as effective as sacral colpopexy and hysterectomy in anatomical outcomes; however, the sacral colpopexy and hysterectomy were associated with increase operating time and blood loss (NP1). Performing hysterectomy at sacral colpopexy was associated with a higher risk of mesh exposure compared with sacral colpopexy without hysterectomy (NP3). There is no sufficient data in the literature to affirm that the uterine conservation improve sexual function (NP3). CONCLUSION: While uterine preservation is a viable option for the surgical management of uterine prolapse the evidence on safety and efficacy is currently lacking. © 2016 Published by Elsevier Masson SAS.

[Assessment before surgical treatment for pelvic organ prolapse: Clinical practice guidelines]. / Bilan avant le traitement chirurgical d'un prolapsus génital : Recommandations pour la pratique clinique.

INTRODUCTION: The issue addressed in this chapter of recommendations is: What is the clinical and para-clinical assessment to achieve in women with genital prolapse and for whom surgical treatment has been decided. What are the clinical elements of the examination that must be taken into account as a risk factor of failure or relapse after surgery, in order to anticipate and evaluate possible surgical difficulties, and to move towards a preferred surgical technique? MATERIAL AND METHODS: This work is based on a systematic review of the literature (PubMed, Medline, Cochrane Library, Cochrane Database of Systemactic Reviews, EMBASE) for meta-analyzes, randomized trials, registries, literature reviews, controlled studies and major not controlled studies, published on the subject. Its implementation has followed the methodology of the HAS on the recommendations for clinical practice, with a scientific argument (with the level of evidence, NP) and a recommendation grade (A, B, C, and professional agreement [AP]). RESULTS: It suits first of all to describe prolapse, by clinical examination, helped, if needed, by a supplement of imagery if clinical examination data are insufficient or in case of discrepancy between the functional signs and clinical anomalies found, or in case of doubt in associated pathology. It suits to look relapse risk factors (high grade prolapse) and postoperative complications risk factors (risk factors for prothetic exposure, surgical approach difficulties, pelvic pain syndrome with hypersensitivity) to inform the patient and guide the therapeutic choice. Urinary functional disorders associated with prolapse (urinary incontinence, overactive bladder, dysuria, urinary tract infection, upper urinary tract impact) will be search and evaluated by interview and clinical examination and by a flowmeter with measurement of the post voiding residue, a urinalysis, and renal-bladder ultrasound. In the presence of voiding disorders, it is appropriate to do their clinical and urodynamic evaluation. In the absence of any spontaneous or hidden urinary sign, there is so far no reason to recommend systematically urodynamic assessment. Anorectal symptoms associated with prolapse (irritable bowel syndrome, obstruction of defecation, fecal incontinence) should be search and evaluated. Before prolapse surgery, it is essential not to ignore gynecologic pathology. CONCLUSION: Before proposing a surgical cure of genital prolapse of women, it suits to achieve a clinical and paraclinical assessment to describe prolapse (anatomical structures involved, grade), to look for recurrence, difficulties approach and postoperative complications risk factors, and to appreciate the impact or the symptoms associated with prolapse (urinary, anorectal, gynecological, pelvic-perineal pain) to guide their evaluation and their treatment. © 2016 Published by Elsevier Masson SAS.

[Prevention and treatment of intra-uterine synechiae: Review of the literature]. / Prévention et traitement des synéchies endo-utérines : revue de la littérature.

Intra-uterine adhesions are a major cause of secondary infertility. The prevalence of adhesions is probably underestimated due to the heterogeneity of the symptoms. An exhaustive literature search using search engines MEDLINE, Pubmed, Cochrane library and Web of Science was performed to make a focus on the origins, consequences and methods of prevention of intra-uterine adhesions. Intra-uterine adhesions are likely to occur after any endo-uterine surgery via dysregulated activation of coagulation chain linked to the inflammatory process. Early and late obstetric complications are also recognized as caused by adhesions. The diagnosis is currently performed by hysteroscopy but it remains an invasive procedure even if it can be done with an ambulatory management. Several research approaches inspired by intra-abdominal surgery for the prevention of pelvic adhesions have been developed. However, no current method of prevention has proven its effectiveness in terms of improving spontaneous fertility. The improvement in surgical practices, the design of new intra-uterine medical devices and new research especially in the field of endometrial stem cells can maybe reduce the rate of adhesions end their complications after intra-uterine surgery.