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.

[Focal HIFU vs robot-assisted total prostatectomy: Functionnal and oncologic outcomes at one year]. / Traitement focal par HIFU versus prostatectomie radicale robot-assistée pour cancer de la prostate localisé : résultats carcinologiques et fonctionnels à 1 an.

OBJECTIVE: To analyse the functional and oncologic outcomes at one year of focal therapy with HIFU compared with total prostatectomy in patients with localised prostate cancer (PCa). PATIENTS AND METHODS: Retrospective and monocentric study from 2008 to 2014 comparing 2 cohorts of patients with localised PCa (T1/T2 clinical stage, Gleason score≤3+4=7 and PSA<15ng/mL), one treated by focal therapy (HIFU-F group), one by robot-assisted total prostatectomy (RATP group). Primary outcome was a trifecta defined as: absence of urinary incontinence, erectile function with sexual relations without treatment, negative PSA with negative surgical margins (RATP group) or negative biopsy cores (HIFU-F group). RESULTS: The 53 patients included in the "HIFU-F" group and the 66 patients in the "RATP" group were similar in terms of preoperative PSA, D'Amico risk group, erectile function but were different in terms of age, prostatic volume, length of cancer, Gleason score. Complication rate was not different. In multivariate analyse with propensity score, "HIFU-F" group achieved a better trifecta score than "RATP" group (OR=8,3, p=0,005). CONCLUSION: In case of low or intermediate risk localised PCa, "HIFU-F" group had better functional outcomes than initial learning curse "RATP" group, at one year. A long-term evaluation by a common endpoint is necessary to judge the oncological equivalence of both techniques. LEVEL OF EVIDENCE: 3.

Detection of locally radio-recurrent prostate cancer at multiparametric MRI: Can dynamic contrast-enhanced imaging be omitted?

OBJECTIVE: The goal of this study was to assess the added value of dynamic contrast-enhanced (DCE) imaging in detecting locally radio-recurrent prostate cancer using multiparametric magnetic resonance imaging (mpMRI) at 3Tesla (T). MATERIALS AND METHODS: We retrospectively analyzed 45 patients with rising prostate-specific antigen level after prostate radiotherapy who underwent mpMRI [T2-weighted (T2w), diffusion-weighted (Dw) and DCE imaging] at 3T before prostate biopsy. Four readers assigned a 5-level Likert score of cancer likelihood in 8 prostate sectors (6 sextants, 2 seminal vesicles) on T2w+Dw and T2w+Dw+DCE images. Biopsy results were used as the standard of reference. RESULTS: T2w+Dw and T2w+Dw+DCE imaging had similar areas under the receiver operating characteristic curves on per-sector (0.87-0.89 vs. 0.87-0.89; P=0.19-0.78) and per-lobe (0.82-0.94 vs. 0.80-0.91; P=0.21-0.84) analysis. Using a Likert score≥2/5 for diagnosis threshold, T2w+Dw+DCE imaging showed non-significantly higher sensitivities on per-sector (0.56-0.72 vs. 0.52-0.73, P=0.34-0.69) and per-lobe (0.80-0.90 vs. 0.73-0.88; P=0.63-0.99) analysis. It also showed non-significantly lower specificities on per-sector (0.74-0.89 vs. 0.82-0.89; P=0.09-0.99) and per-lobe (0.48-0.81 vs. 0.61-0.84; P=0.10-0.99) analysis. Weighted kappa values were respectively 0.57-0.70 and 0.55-0.66 for T2w+Dw and T2w+Dw+DCE imaging at the sector level, and 0.66-0.83 and 0.58-0.85 at the lobe level. CONCLUSION: The use of DCE MR imaging tends to increase sensitivity and decrease specificity for all readers, but the differences are not significant.

[Management of rectourethral fistulas with the York Mason procedure: surgical techniques and outcomes]. / Traitement des fistules uréthro-rectales par voie trans-anorectale de York Mason: technique et résultats.

OBJECTIVE: To report our experience for the management of urethro-rectal fistula by the York Mason technique. PATIENTS AND METHODS: We retrospectively analyzed the data of patients treated surgically for FUR by the technique of York Mason, between 2000 and 2012. RESULTS: Seventeen patients were included in the study. All patients had a bowel diversion before surgery. We observed four recurrences of FUR (23.5%). Recurrences occurred in a radiation field for two patients and in a oncologic recurrence for 1 patient. The fourth recurrence was treated by a second procedure of York Mason successfully. CONCLUSION: In our study, the York Mason technique was safe and reproducible for the treatment of FUR. The main factor of failure was a history of pelvic radiotherapy.

Salvage high-intensity focused ultrasound ablation for prostate cancer local recurrence after external-beam radiation therapy: prognostic value of prostate MRI.

AIM: To assess the prognostic value of magnetic resonance imaging (MRI) before salvage high-intensity focused ultrasound (HIFU) for locally recurrent prostate cancer after external-beam radiotherapy (EBRT). MATERIALS AND METHODS: Forty-six patients who underwent prostate MRI before salvage HIFU for locally recurrent prostate cancer after EBRT were retrospectively studied. HIFU failure was defined as a prostate-specific antigen (PSA) value >nadir + 2 ng/ml (Phoenix criteria) or positive follow-up biopsy or initiation of any other salvage therapy. The following prognostic parameters were assessed: neoadjuvant hormone therapy, clinical stage and Gleason score of recurrence, PSA level and velocity at HIFU treatment, and six MRI-derived parameters (prostate volume, tumour volume, extracapsular extension, seminal vesicle invasion, tumour extension into the apex or anterior to the urethra). RESULTS: Two factors were significant independent predictors of salvage HIFU failure: the PSA level at HIFU treatment (p < 0.012; risk ratio: 1.15, 95% CI: 1.03-1.29) and the tumour extension anterior to the urethra, as assessed by MRI (p = 0.046, risk ratio: 2.51, 95% CI: 1.02-6.16). CONCLUSION: The location of cancer recurrence anterior to the urethra on MRI is an independent significant predictor of salvage HIFU failure for locally recurrent prostate cancer after EBRT. Therefore, MRI may be useful for patient selection before post-EBRT salvage HIFU ablation.

[Treatment of stress urinary incontinence after prostate surgery: results of the artificial urinary sphincter after suburethral sling failure]. / Traitement de l'incontinence urinaire d'effort après prostatectomie : résultats du sphincter urinaire artificiel après échec de bandelette sous-urétrale.

OBJECTIVE: To determine whether the presence of a previously implanted suburethral sling for post-prostatic surgery incontinence influences the outcomes of subsequent AUS implantation. PATIENTS AND METHODS: A retrospective study comparing 15 patients who underwent AUS placement after suburethral sling failure between November 2004 and December 2009 to 15 patients who underwent AUS placement as first-line treatment during the same period. Demographic characteristics, preoperative assessment of urinary incontinence and technique of implantation of the AUS were similar in the both arms. A USP(®) continence questionnaire was sent to patients by mail. Success was defined as a subjective improvement of the incontinence in patients using less than one pad per day. RESULTS: No perioperative incidents were noted in either arm. Mean operative time, the size of implanted cuffs, duration of catheterisation, length of hospital stay and postoperative complication rate, as well as the rate of surgical revision, were similar in both arms. The follow-up was slightly lower in the first arm (21 vs. 28.8 months, P=0.83). Stress incontinence and bladder overactivity scores of the USP(®) questionnaire, as well as success rates (73.3 vs. 80%, P=0.67), were equivalent in both arms. CONCLUSION: The results associated with the AUS procedure were not significantly different between men who had a suburethral male sling implanted before and those who had the AUS implanted as a first-line treatment.

Complete high-intensity focused ultrasound in prostate cancer: outcome from the @-Registry.

BACKGROUND: To analyze data on patients with localized prostate cancer who were treated with complete high-intensity focused ultrasound (HIFU) prospectively captured within a voluntary HIFU user database (@-Registry). METHODS: The @-Registry includes data from consecutive patients treated with Ablatherm (EDAP-TMS) HIFU at nine European Centres during the period 1994 and 2009. For this analysis, the data repository was reviewed for information on patients with localized prostate cancer (T1 -- T2) treated with complete (whole-gland) HIFU on the basis of an anterior-posterior prostate height of ≤24 mm and a treated volume >120% of the prostate volume. Patients were regularly followed with PSA measurement and biopsy. Biochemical failure was defined for this study as PSA nadir +2 ngml(-1) (Phoenix definition). Disease-free survival was based on a biopsy, retreatment and biochemical data. Patients were risk group-stratified using the D'Amico classification system. RESULTS: The median follow-up was 2.8 years for the 356 patients included in the analysis. The majority could be classified as either low (44.9%) or intermediate risk (39.6%); 14.6% patients were classified as high risk. The median (mean, s.d.) PSA nadir was 0.11 ng ml(-1) (0.78 and 3.6), achieved at a mean (s.d.) of 14.4 (11.6) weeks after HIFU. Follow-up biopsies on 226/356 (63.5%) patients revealed an overall negative biopsy rate of 80.5% (182/226); there was no statistically significant difference in positive biopsy rate by risk group-stratification. Actuarial freedom from biochemical recurrence at 5 and 7 years according to the Phoenix definition was 85% and 79%, respectively. Disease-free progression rates at 5 and 7 years were 64% and 54%, respectively. CONCLUSIONS: Whole-gland prostate HIFU as primary monotherapy for localized prostate cancer achieves a recurrence-free survival in short-term analysis as assessed by prostate biopsy and serum PSA endpoints in a majority of patients.

[HIFU for prostate cancer in patients with a history of severe colorectal disease]. / Cancer de prostate associé à une pathologie rectale sévère. Résultats préliminaires carcinologiques et fonctionnels du traitement par HIFU (Ablatherm).

OBJECTIVES: To report the functional and oncological outcomes of HIFU for prostate cancer in patients with a history of severe colorectal disease. METHODS: Between 2002 and 2009, 14 patients with a history of severe colorectal disease (cancer, lymphoma, inflammatory bowel diseases [IBD]) were treated with HIFU as a primary care option for localized prostate cancer. RESULTS: Mean age was 65.8 ± 6.1 years. Mean time between colorectal disease treatment and HIFU was 10.6 ± 6.8 years. The mean Prostate Specific Antigen (PSA) before HIFU was 12.1 ng/mL (4.5-55). Gleason score was inferior or equal to 6 in four patients (28.6%), equal to 7 in nine patients (64.3%) and superior or equal to 8 in one patient (7.1%). The mean prostate volume before HIFU was 22.1 ± 11.7 mL. The number of HIFU sessions per patient was 1.35. The mean nadir PSA was 0.61 ± 0.82 ng/mL. Systematic control biopsies were negative in seven patients (50%). Mean follow-up was 22 months with a 35.7% complication rate (three erectile dysfunctions, two urinary stress incontinences). No recto-urethral fistula occurred. CONCLUSION: HIFU was an interesting therapy for patients with a history of colorectal disease for whom regular treatment was challenging or non feasible.

[Outcomes of HIFU for localised prostate cancer using the Ablatherm Integrate Imaging® device]. / Traitement du cancer localisé de la prostate avec l'appareil Ablatherm Imagerie Intégrée® : résultats carcinologiques et fonctionnels.

OBJECTIVES: To report the functional and oncological outcomes of HIFU for prostate cancer using the Ablatherm Integrate Imaging(®) device. METHODS: Between January 2005 and June 2009, all patients treated with HIFU as a primary care option for localized prostate cancer and fulfilling the French Urological Association (AFU) guideline were included in this study. Validated questionnaires were used to assess continence, potencies and quality of life. RESULTS: A total of 297 patients met the inclusion criteria: 149 were low risk and 148 were intermediate risk according to d'Amico's risk group. The median prostate specific antigen (PSA) nadir was 0.12ng/ml with 65% of patients reaching a nadir less than 0.3 ng/ml. Systematic control biopsies were performed on 175 patients with 89% of negative biopsies. The disease free survival rate at 40 months was 79% for low risk group and 62% for intermediate risk group. The pre and post-HIFU treatment International Prostate Symptoms Score (IPSS) score and quality of life questionnaire were not statistically different. In the opposite, the pre and post-HIFU erection function and continence status were significantly different. CONCLUSION: Local control and Biochemical Free Survival Rate achieved with HIFU were similar to those expected with conformal external radiation beam therapy. Among the functional outcomes, potency was the most impacted by the treatment.

[Bone-anchored suburethral sling complicated by pubic osteomyelitis: a case report]. / Bandelette sous-urétrale avec ancrage osseux compliquée d'une ostéomyélite pubienne : à propos de deux cas.

The bulbo-urethral compression through a non-resorbable sling is a new therapeutic approach in the management of male stress urinary incontinence after prostatic surgery. Several slings are being evaluated and their way of fixing is variable according to the technique adopted. The InVancetrade mark process ensures bulbo-urethral compression by a synthetic sling anchored to the ischio-pubic rami through several titanium screws. We report the case of two patients whose operating suites of the InVancetrade mark bone-anchored male sling surgery have been marked by the appearance of a perineal suppuration associated with a pubic osteomyelitis. The healing was achieved after explantation of the material implanted (screws and sling) with bone debridement and prolonged antibiotics.

[MR detection of local prostate cancer recurrence after transrectal high-intensity focused US treatment: preliminary results]. / Détection par IRM des récidives locales du cancer de prostate après traitement par ultrasons focalisés de haute intensité (HIFU) transrectaux: étude préliminaire.

PURPOSE: To assess T2W and dynamic: contrast-enhanced (DCE) MR imaging in the detection of local tumor recurrence after transrectal high-intensity focused US (HIFU) treatment. MATERIALS AND METHODS: Fifteen patients treated by HIFU for prostate cancer were referred for MR due to biological evidence of tumor recurrence. Axial, sagittal and coronal T2W images and DCE images (12 3-mm thick axial images, temporal resolution: 15 seconds) were obtained first. Transrectal biopsies were then obtained under US guidance. MR findings were compared to biopsy results for 10 prostate sectors. RESULTS: Biopsies demonstrated tumor recurrence in 13/15 patients (23/108 sectors). On T2W images, the treated prostate tissue was diffusely hypointense which interfered with interpretation. Three patients (5 sectors) had suspicious areas of T2W signal abnormality and 15 patients (29 sectors) had suspicious areas on DCE scans. An analysis per sector for T2W and DCE imaging showed sensitivity, specificity, positive predictive and negative predictive values respectively of 0.13, 0.98, 0.6 and 0.81 and 0.70, 0.85, 0.55 and 0.91. DCE MR was strongly predictive of positive biopsy results (Odds ratio: 12.8 (95% confidence interval: 4.4-37.3)) whereas T2W imaging was not (Odds ratio: 4.0 (95% confidence interval: 0.5-30)). CONCLUSION: MR, especially DCE MR, is promising for the detection and localization of local prostate cancer recurrence after transrectal HIFU treatment.

Salvage radiotherapy after high-intensity focused ultrasound for localized prostate cancer: early clinical results.

OBJECTIVES: To evaluate the first results of salvage radiotherapy after high-intensity focused ultrasound (HIFU) in terms of feasibility, tolerance, and oncologic control. METHODS: From March 1995 to May 2004, 45 patients presenting with local failure after HIFU underwent salvage radiotherapy alone (n = 32) or combined with hormonal therapy (n = 13). The modalities of radiotherapy are described. Tolerance was evaluated using the Radiation Therapy Oncology Group score for urinary and digestive side effects, and incontinence was evaluated using the Ingelman Sundberg score. Patients answered a questionnaire. For the 32 patients who underwent radiotherapy alone, the oncologic early results were given by the disease-free survival rate, defined as no biochemical progression and no androgen suppression therapy. RESULTS: The median and mean follow-up were 40 and 46 months, respectively, for the whole series. No additional digestive or urinary toxicity developed with salvage radiotherapy after HIFU. The data from 32 patients were evaluated, with a median follow-up of 37 months after radiotherapy. The 5-year disease-free survival rate was 64% for the 32 patients evaluated. The 5-year disease-free survival rate reached 80% for patients treated for positive biopsy findings and was 44% for those with isolated biochemical failure. CONCLUSIONS: Salvage radiotherapy after HIFU for local recurrence is feasible, with no additional toxicity. The early oncologic results are encouraging when isolated local recurrence is proven but longer follow-up is needed.

[Locally recurrent prostatic adenocarcinoma after exclusive radiotherapy: results of high intensity focused ultrasound]. / Adénocarcinome prostatique en récidive locale après radiothérapie exclusive: résultats du traitement par ultrasons focalisés.

OBJECTIVES: To determine the efficacy and adverse effects of high intensity focused ultrasound (HIFU) for the treatment of local recurrence of prostate cancer after exclusive external beam radiotherapy. MATERIAL AND METHODS: Seventy-two patients with histologically and biologically documented local recurrence after radiotherapy were treated by HIFU. The mean age was 68.27+/-5.93 years, and mean PSA was 6.64+/-7.26ng/ml. Thirty patients were treated according to standard parameters and 42 according to specific parameters. ASTRO 2005 criteria, specific for salvage therapy (Phoenix consensus), were used to define recurrence. Progression-free survival was calculated by the Kaplan-Meier method. RESULTS: Mean follow-up was 39+/-28 months. The negative biopsy rate was 80% and the median nadir PSA was 0.10ng/ml. Specific survival was 94% at three years and 90% at five years, and progression-free survival was 50% at three years and 44% at five years. The urinary incontinence rate was 44% (grade 1 : 12%, grade 2/3 : 32%) and the urethral stricture or bladder neck stenosis rate was 30%. The use of specific parameters reduced the incidence of severe incontinence (19% versus 50, P=0.005) and stenosis (24% versus 40). CONCLUSIONS: Treatment with HIFU achieved a five-year progression-free survival of 44%, but patients must be clearly informed about the high rate of adverse effects.

[AMS 800 artificial urinary sphincter implantation: can the penoscrotal approach constitute an alternative to the perineal approach?]. / Implantation du sphincter urinaire artificiel AMS 800: la voie péno-scrotale est-elle une alternative à la voie périnéale ?

OBJECTIVE: To compare the short-term results of penoscrotal and perineal artificial urinary sphincter implantation. PATIENTS AND METHODS: From May 2005 to February 2007, 37 artificial urinary sphincters were implanted successively, via a penoscrotal approach in 16 cases and via a perineal approach in 21 cases. Incontinence was secondary to prostate surgery (n=36) and pelvic trauma (n=1). Seventeen patients had a history of external beam radiotherapy. The times and modalities of activation of the sphincter were identical in the two groups. RESULTS: The mean age of the patients, the mean operating time, the mean catheterization duration, the mean hospital stay and the mean postoperative follow-up were equivalent in the two groups. Six urethral erosions (37.5%) and one scrotal erosion due to the pump (6.6%) were observed in the penoscrotal group and infection of the sphincter in two patients (9.5%) and pump migration in another two patients (9.5%), but no urethral erosions were observed in the perineal group. The success rate without revision was 56% in the penoscrotal group and 71.5% in the perineal group. CONCLUSION: The perineal approach is the reference incision, as the penoscrotal approach is associated with a high rate of erosion. The penoscrotal urethral approach can constitute an alternative when the bulbar urethra cannot be used.