Tolerance and efficacy of platelet-rich plasma injections in Peyronie's disease: Pilot study.

INTRODUCTION: Platelet-rich plasma (PRP) injections are increasingly proposed for the treatment of Peyronie's disease since the discontinuation of Xiapex® despite poorly understood results. OBJECTIVES: Evaluation of the tolerance and efficacy of intra-plate PRP injections in patients with Peyronie's disease. METHODS: Three intra-plate injections of PRP were performed 15 days apart in 17 patients with Peyronie's disease. The Peyronie's Disease Questionnaire (PDQ) and the measurement of the angle of curvature of the erect penis were assessed before treatment and then 1, 3 and 6 months after treatment. Erectile function was assessed by different questionnaires (IIEF-EF, EHS, SEP, sexual discomfort score). RESULTS: No side effects were noted during the study period. Three months after treatment, all three PDQ domains were significantly improved (P=0.002; P=0.015; P=0.017 respectively). The angle of curvature of the penis was significantly decreased by 11.8° with a mean angle of 40.4° before treatment and 28.6° after (P=0.007). The IIEF-EF score was significantly improved after treatment (mean preoperative value: 10.67) with a gain of 5 points at months 1 and 6 (P=0.01 and P=0.036 respectively) and 7 points at month 3 (P=0.04). CONCLUSION: Our initial experience suggests that PRP injections for Peyronie's disease are safe. Although the limited data is suggestive of efficacy, a placebo control will be required for confirmation.

[Congenital penile curvature: Guidelines from the Andrology and Sexual Medicine Committee of the French Association of Urology (CAMS-AFU)]. / Courbures congénitales du pénis : recommandations du Comité d'andrologie et de médecine sexuelle de l'Association française d'urologie.

INTRODUCTION: Guidelines regarding congenital penile curvature (CPC) are lacking, and this pathology has not been the subject of French recommendations to date. The Andrology and Sexual Medicine Committee (CAMS) of the French Association of Urology (AFU) propose a series of clinical practice recommendations (CPR) by answering five clinical questions concerning the diagnosis and treatment of this pathology. MATERIALS AND METHODS: After a bibliographic research between 2000 and 2021, followed by a critical reading according to the CRP method. These recommendations were written to answer five questions: (1) What are the different types of CPC? (2) What are the reasons for consultation? (3) What are the assessment methods for CPCs and their consequences? (4) What are the indications for CPCs treatment? (5) What are the corrective modalities for the treatment of CPC? RESULTS: There are two main phenotypes: CPC type 4 (the most common) and chordee without hypospadias. The diagnosis of CPC is clinical and established through enquiry and clinical examination associated with photos of the erect penis. Support can be offered if the curvature is responsible for a disability and/or sexual dissatisfaction linked to a deformation making penetration difficult and/or in the event of significant psychological impact. Only surgical treatments have demonstrated their effectiveness. For type 4 CPCs, corporoplasty (excisional, incisional, or incisionless techniques) is the gold standard. CONCLUSION: These recommendations provide support for the management of patients consulting with CPC.

Pilot study of intra-cavernous injections of platelet-rich plasma (P-shot®) in the treatment of vascular erectile dysfunction.

INTRODUCTION: Intracavernosal injections of platelet-rich plasma (PRP) or P-shot® are increasingly proposed as a curative treatment for organic sexual dysfunction despite the lack of evidence of effectiveness. OBJECTIVES: We conducted a pilot study to evaluate the safety and efficacy of intracavernous PRP injections in patients with vascular erectile dysfunction (ED). METHODS: Three intracavernosal injections of PRP were performed 15days apart in 15 patients with vascular ED unresponsive to medical treatment with 5-phosphodiesterase inhibitors and/or prostaglandin E instillations or injections. Questionnaires assessing erectile function (IIEF-EF, EHS, SEP, Sexual discomfort score) were completed prior to treatment and 1, 3 and 6 months after the last injection. RESULTS: No side effects were noted during the study period. The IIEF-EF score was significantly improved after treatment (P<0.001) with a gain of 5 points at 1month, 4 points at 3months and 3 points at 6months (respectively P=0.001, P=0.003 and P=0.022). The other questionnaires did not change significantly. In total, 20% of patients considered that the erection lasted long enough to have a sexual intercourse (SEP score) before P-shot® versus 26.7% after the treatment (P=1). CONCLUSION: This study suggests that the effect of P-Shot® remains moderate in cases of ED with vascular origin. Larger clinical studies are needed to determine the real effectiveness of this therapeutic strategy. LEVEL OF PROOF: 2.

[Which management for anterior urethral stricture in male? 2021 guidelines from the uro-genital reconstruction urologist group (GURU) under the aegis of CAMS-AFU (Committee of Andrology and Sexual Medicine of the French Association of Urology)]. / Quelle prise en charge pour les sténoses de l'urètre antérieur chez l'homme ? Recommandations 2021 du Groupe d'urologue de reconstruction uro-génitale (GURU) sous l'égide du CAMS-AFU (Comité d'andrologie et de médecine sexuelle de l'association française d'urologie).

OBJECTIVE: The purpose of this first french guideline is to provide a clinical framework for the diagnosis, treatment and follow-up of anterior urethral strictures. The statements are established by the subgroup working on uro-genital reconstruction surgery (GURU) from the CAMS-AFU (Andrology and Sexual Medicine Committee from the French Association of Urology). MATERIAL AND METHODS: These guidelines are adapted from the Male Urethral Stricture : American Urological Association Guideline 2016, updated by an additional bibliography from January 2016 to December 2019. Twenty-seven main scenarios seen in clinical practice are identified: from diagnosis, to treatment and follow-up. In addition, this guidelines are powered by anatomical diagrams, treatment algorithms, summaries and follow-up tables. RESULTS: Anterior urethral strictures are a common condition (0,1 à 1,4 %) in men. The diagnosis is based on a trifecta including an examination with patient reported questionnaires, urethroscopy and retrograde urethrography with voiding cystourethrography. Short meatal stenosis can be treated by dilation or meatotomy, otherwise a urethroplasty can be performed. First line treatment of penile strictures is urethroplasty. Short bulbar strictures (<2cm) may benefit from endourethral treatment (direct visual internal urethrotomy or dilation). In case of recurrence or when the stenosis measures more than 2 cm, a urethroplasty will be proposed. Repeated endourethral treatment management are no longer recommended except in case of palliative option. Urethroplasty is usually done with oral mucosa graft as the primary option, in one or two stages approach depending on the extent of the stenosis and the quality of the tissues. Excision and primary anastomosis or non-transecting techniques are discussed for bulbar urethra strictures. Follow-up by clinical monitoring with urethroscopy, or retrograde urethrography with voiding cystourethrography, is performed at least the first year and then on demand according to symptoms. CONCLUSION: Anterior urethral strictures need an open surgical approach and should be treated by urethroplasty in most cases. This statement requires a major paradigm shift in practices. Training urologist through reconstructive surgery is the next challenge in order to meet the demand.

[French Urological Association (AFU) guidelines for Peyronie's disease assessment and treatment]. / Recommandations pour l'évaluation et la prise en charge de la maladie de Lapeyronie : rapport du comité d'andrologie et de médecine sexuelle de l'AFU.

INTRODUCTION: Peyronie's disease is a common cause for consultation in urology. Many controversies surround its treatment. No French Guidelines have been published so far. The Committee of Andrology and Sexual Medicine of the French Association of Urology therefore offers a series of evidence-based recommendations. MATERIALS AND METHODS: These recommendations are made according to the ADAPTE method, based on European (EAU, ESSM), American (AUA, ISSM) and Canadian (CAU) recommendations, integrating French specificities due to the availability of treatments, and an update of the recent bibliography. RESULTS: The assessment of the disease is clinical. Patients with functional impairment or significant psychological repercussions may be offered treatment. The benefits and drawbacks of each treatment should be explained to the patient. Regarding non-surgical treatments, no available treatment has market authorization in France. Vitamin E is not recommended. Analgesic (oral or low-intensity shock waves) or proerectile treatments may be offered as needed, as well as traction therapy. Due to the unavailability of collagenase injections, verapamil injections may be offered. Surgical treatments are to be considered in the stabilized phase of the disease, and consist of performing a plication, an incision-graft or the placement of a penile implant according to the patient's wishes, the curvature and the penis size, as well as erectile function. Combination treatments can be offered. CONCLUSION: The management of Peyronie's disease is complex, and the levels of evidence for treatments are generally low. The success of treatment will depend on the quality of the initial assessment, the patient's information and understanding of the expected effects, and the practitioner's experience.

[Recommendations of the Committee of Andrology and Sexual Medicine of the AFU concerning the management of andrological and sexual medicine pathologies during the COVID-19 crisis]. / Recommandations du Comité d'andrologie et de médecine sexuelle de l'AFU concernant la prise en charge andrologique et en médecine sexuelle en contexte et en sortie de crise sanitaire liée au COVID-19.

OBJECTIVE: To assist urologists in the management of andrological and sexual medicine pathologies during the COVID-19 crisis. MATERIAL AND METHOD: Use of the formalized consensus method. RESULTS: The medical and surgical management of patients in andrology and sexual medicine must be adapted. Consultations should, as far as possible, be carried out by tele-consultation. For operative procedures, the delay between the operative decision and the date of (re)scheduling of the procedure will depend on: (1) the level of criticality of the clinical situation; (2) the type of intervention; (3) the functional and psychological repercussions, including quality of life while waiting for the procedure; (4) the notion of losing the chance of having an optimal outcome; (5) the risk of potential complications from delaying a procedure for too long; and (6) taking into account the patient's risk factors for severe forms of COVID-19. The protection of urologists from COVID-19 should be considered. Each urologist must make the best decision for the patient, taking into account the acceptable time frame and quality of life impact before surgical management, the COVID risk parameters, the technical and anesthetic feasibility and the structural possibility of the health care institution to ensure a specific dedicated pathway during the COVID-19 health crisis. CONCLUSION: The management of andrological and sexual medicine pathologies must be adapted to the COVID-19 crisis context. Some patients may require surgery, including in emergency. These recommendations are transitional and will end with the COVID-19 crisis.

[Urethro-vesical anastomosis reconstruction using extra-peritoneal robot-assisted laparoscopy for anastomotic stenosis after radical prostatectomy]. / Réfection d'anastomose urétro-vésicale par voie extra-péritonéale laparoscopique robot-assistée pour sténose anastomotique post-prostatectomie radicale.

INTRODUCTION: Urethro-vesical anastomosis stenosis following radical prostatectomy is a rare complication but represents a challenging situation. While the first-line treatment is endoscopic, recurrences after urethrotomies require a radical approach. We present the updated results of our patient's cohort treated by pure robotic anastomosis refection. MATERIAL AND METHODS: This is a retrospective, single-center study focusing on one surgeon's experience. Patients presented an urethro-vesical stricture following a radical prostatectomy. Each patient received at least one endoscopic treatment. The procedure consisted of a circumferential resection of the stenosis, followed by a re-anastomosis with well-vascularized tissue. We reviewed the outcomes in terms of symptomatic recurrences and continence after the reconstructive surgery. RESULTS: From April 2013 to May 2020, 8 patients underwent this procedure. Half of the patients had previously been treated with salvage radio-hormonotherapy. The median age was 70 years (64-76). The mean operative time was 109minutes (60-180) and blood loss was 120cc (50-250). One patient had an early postoperative complication, with vesico-pubic fistula. The average length of stay was 4.6 days (3-8). Mean follow-up was 24.25 months (1-66). Half of the patients experienced a recurrence at a median time of 8.25 months (6-11) after surgery. Five patients experienced incontinence of which 3 required an artificial urinary sphincter implantation. CONCLUSION: Extra-peritoneal robot-assisted urethro-vesical reconstruction is feasible and safe to manage bladder neck stricture after radical prostatectomy. The risk of postoperative incontinence is high, justifying preoperative information. LEVEL OF EVIDENCE: III.

[Recommendations of the Committee of Andrology and Sexual Medicine of the AFU concerning the management of Varicocele]. / Recommandations du Comité d'Andrologie et de Médecine Sexuelle de l'AFU concernant la prise en charge de la Varicocèle.

The diagnosis of varicocele is clinical, carried out in supine and standing position and in Valsalva maneuver. Only clinical varicoceles have to be treated. A scrotal ultrasound with Doppler is generally performed as part of the infertile man's evaluation or in case of examination difficulties. The main indication for varicocele treatment is the adult man with clinical varicocele and abnormalities of sperm parameters, in a context of infertility of couple, with a partner having a satisfactory ovarian reserve and no cause of female infertility or a curable infertility cause. The decision to treat varicocele must therefore be taken after evaluation of the two partners of the couple. Adults with symptomatic varicocele and those with spermogram abnormalities may also be offered a cure for their varicocele even in the absence of a paternity plan, as well as adolescents with reduced testicular growth, an ipsilateral decrease testicular volume, or a size gradient between the 2 testes. The cure of varicocele can be carried out by surgery or by percutaneous embolization. Microsurgery (inguinal or subinguinal) offers lower rates of recurrence and complications than high surgical approaches (laparoscopic or not) and surgeries without magnification. It is therefore the reference surgical technique. Percutaneous retrograde embolization is a minimally invasive alternative to microsurgery offering satisfactory outcomes with rare and often benign complications. The cure for varicocele results in an improvement in sperm parameters and recent data seem to confirm that it increases the natural pregnancy rate. These results appear after a delay of 3 to 9 months (at least 1 to 2 cycles of spermatogenesis). When the sperm involvement was severe (azoospermia, severe oligospermia), the improvement of the spermogram allow (1) to avoid surgery testicular sperm extraction or (2) perform intrauterine insemination rather than ICSI.

[Biotherapies for erectile dysfunction and Peyronie's disease: Where are we now?] / Biothérapies pour les troubles de l'érection et la maladie de la Peyronie : ou en est-on ?

INTRODUCTION: Clinical trials of cell therapy for erectile dysfunction (ED) and Peyronie's disease (PD) were recently conducted after preclinical studies. AIMS: The aims of this study are to give an update on biotherapy for ED and PD and to describe the regulatory framework for these therapies. MATERIALS AND METHODS: A literature review was performed through PubMed and Clinical.trials.gov addressing cell therapy for ED and PD and using following keywords "erectile dysfunction", "Peyronie's disease", "stem cell", and "platelet-rich plasma". RESULTS: Preclinical studies in rodent models have shown the potential benefit of cell therapy for ED after radical prostatectomy or caused by metabolic diseases, and PD. The tissues used to obtain the therapeutic product were bone marrow, adipose tissue and blood (PRP, platelet-rich plasma). Mechanism of action was shown to be temporary and mainly paracrine. Four clinical trials were published concerning ED after radical prostatectomy and in diabetic patients and one for PD. Eleven clinical trials including three randomized trials are currently going on. Preclinical and preliminary clinical results suggested the possibility to improve spontaneous erectile function and response to pharmaceutical treatment in initially non-responder patients. This effect is mediated by an improvement of penile vascularization. A reduction of penile curvature without side effect was noted after injections into the plaque of PD patients. Most of these therapeutic strategies using autologous cells were considered as "Advanced Therapy Medicinal Products" with strict regulatory frameworks imposing heavy constraints, in particular in case of "substantial" modification of the cells. The regulatory framework remains unclear and more permissive for PRP and cell therapy processes with extemporaneous preparation/injection and no "substantial" modifications. CONCLUSIONS: First results on cell therapy for ED and PD are promising. The regulatory framework can significantly change according to cell preparations and origins leading to various constraints. This regulatory framework is crucial to consider for the choice of the procedure.

[Is transition from pure laparoscopic to robotic-assisted radical prostatectomy associated with increase of surgical procedures for urinary incontinence and erectile dysfunction?] / L'introduction de la chirurgie robot-assistée pour la prostatectomie totale s'accompagne-t-elle d'une modification du nombre d'interventions secondaires pour troubles fonctionnels génito-urinaires ?

OBJECTIVE: To study the impact of changing the technique of radical prostatectomy [pure laparoscopic radical (PR-Lap) to robot-assisted radical prostatectomy (RP-Rob)] on the rate of secondary procedures for urinary incontinence (UI) and erectile dysfunction (ED). MATERIAL: Retrospective study evaluating the number and type of surgical procedures for post-RP UI and DE between 2008 and 2015, according to the technique of (RP-Lap or RP-Rob). RESULTS: Between 2008 et 2015, 2046 RP were performed in our department including 372 RP-Lap and 1674 RP-Rob. Among these patients, 84 (4%) had a surgical procedure for post-RP UI (18 AMS800, 9 balloons Pro-Act, and 57 male slings) and 15 (0.7%) had implantation of penile prosthesis for post-RP ED; 16 (0.7%) patients had both procedures. The mean delay between RP and UI surgery decrease from 3.2 years in 2008 to 1 year in 2015 and remain stable for penile prosthesis implantation (mean delay: 3.4 years). The overall rates of secondary procedures for UI and DE remained stable and below 5% and 1.7%, respectively, even during the transition period. For each year of PR studied, the rates of secondary procedure were higher in the RP-Lap group. CONCLUSION: Changing the technique of RP from RP-Lap to PR-Rob has a favorable impact on the rate of secondary procedures for UI and ED from the outset.

[Penile prosthesis implantation: Indications and outcomes]. / Indications et résultats des implants péniens.

OBJECTIVE: Our aim was to present the indications and the outcomes of penile prosthesis implantation. METHODS: A literature review was performed through PubMed using the following keywords: penile implantation ; penile prosthesis; erectile dysfunction. RESULTS: Evolution of penile prosthesis devices led to get a fiable and effective treatment for men with erectile dysfunction who do not respond to less invasive therapy. Penile implant can also be useful in the treatment of Peyronie's disease, priapism and transgender surgery. Precise information related to this surgery, especially complications, permits to obtain high satisfaction scores. CONCLUSION: Penile implant is a reliable and safe solution for the management of erectile dysfunction resulting to high couple satisfaction ratings.

Stem-cell therapy for erectile dysfunction.

Stem cell-based therapies have been recently investigated in the field of organic erectile dysfunctions, such as those associated with diabetes or the treatment of prostate cancer. The overall aim is to repair the repair the underlying penile cellular damage. Here, we review the rationale behind the use of stem cells injection in post-radical prostatectomy erectile dysfunction (pRP-ED).Radical prostatectomy for prostate cancer induces complex neurologic and vascular injuries that cause one of the most difficult-to-treat forms of erectile dysfunction. Evidence from animal models replicating pRP-ED suggests that intracavernous injection of autologous bone marrow mononuclear cells (BM-MNCs) may represent the first curative approach. Several clinical trials are ongoing and two of them have been completed with encouraging results.

[Functional results and treatment of functional dysfunctions after radical prostatectomy]. / Résultats fonctionnels et prise en charge des troubles fonctionnels après prostatectomie totale.

OBJECTIVE: To describe the functional results and treatment of functional dysfunctions after radical prostatectomy for localized prostate cancer. MATERIAL AND METHOD: Bibliography search was performed from the database Medline (National Library of Medicine, Pubmed) selected according to the scientific relevance. The research was focused on continence, potency, les dyserections, couple sexuality, incontinence, treatments of postoperative incontinence, dysrection and trifecta. RESULTS: Radical prostatectomy is an elaborate and challenging procedure when carcinological risk balances with functional results. Despite recent developments in surgical techniques, post-radical prostatectomy urinary incontinence (pRP-UI) continues to be one of the most devastating complications, which affects 9-16% of patients. Sphincter injury and bladder dysfunction are the most common causes or pRP-UI. The assessment of severity of pRP-UI that affects the choice of treatment is still not well standardized but should include at least a pad test and self-administered questionnaires. The implantation of an artificial urinary sphincter AMS800 remains the gold standard treatment for patients with moderate to severe pRP-UI. The development of less invasive techniques such as the male sling of Pro-ACT balloons has provided alternative therapeutic options for moderate and slight forms of pRP-UI. Most groups now consider the bulbo-urethral compressive sling as the treatment of choice for patients with non-severe pRP-UI. The most appropriate second-line therapeutic strategy is not clearly determined. Recent therapies such as adjustable artificial urinary sphincters and sling and stem cells injections have been investigated. Maintenance of a satisfying sex life is a major concern of a majority of men facing prostate cancer and its treatments. It is essential to assess the couple's sexuality before treating prostate cancer in order to deliver comprehensive information and consider early therapeutic solutions adapted to the couple's expectations. Active pharmacological erectile rehabilitation (intracavernous injections or phosphodiesterase type 5 inhibitors [PDE5i] on demand, during in the month following surgery) or passive (daily PDE5i after surgery) might improve the quality of erections especially in response to PDE5i. Unimpaired aspects of sexual response (orgasm) may, when the erection is not yet recovered, represent an alternative allowing the couple to preserve intimacy and complicity. Androgen blockade is a major barrier to maintain or return to a satisfying sex. Trifecta is a simple tool to present in one way the results of radical prostatectomy: in case of bilateral neurovascular preservation, Trifecta is 60% whatever the surgical approach. CONCLUSION: Radical prostatectomy is an elaborate and challenging procedure when carcinological risk balances with functional results. Various treatments of postoperative incontinence and dysrections exist. Functional disorders after surgery have to be treated to ameliorate quality of life of patients.

[Intrinsic sphincter deficiency and female urinary incontinence]. / Insuffisance sphinctérienne et incontinence urinaire de la femme.

OBJECTIVE: Stress urinary female incontinence (SUI) is primary due to intrinsic sphincter deficiency (ISD) and urethral hypermobility. Despite a lack of standardised international definition, ISD needs to be clearly diagnosed in order to be correctly treated. This work is an update about the female ISD produced from a review of a published article. MATERIAL AND METHODS: This review of article published on this subject in the Medline (Pubmed database), selected according to their scientific relevants, of consensus conferences and published guidelines, has been performed by the committee for women pelvic floor surgery of the French Urological Association. RESULTS: Although there is no international consensus definition, we can consider that the ISD is a composite concept combining urodynamic data (MUCP < 20 or 30 cmH20) and one or more clinical information (no urethral mobility, negative urethral support test, failure of a first surgery, leakage during abdominal straining, high stress incontinence scores). Imaging can provide additional evidence for intrinsic sphincter deficiency diagnosis, but the correlation between imaging and function remains low. By standardizing methodology and interpretations to better diagnose women with ISD, it may be possible to improve preoperative planning and outcomes for these patients. A retropubic midurethral sling can be performed as a first surgery. In case of a lack of urethral mobility, the artificial urinary sphincter (AUS) remains the gold standard. Adjustable continence therapy (ACT(®)) can be proposed as an alternative option. The efficacy and safety of muscle-derived cell therapy in ISD needs more studies. Injection of bulking agents may be an option according to the severity and the expectations of the patient. Bladder overactivity needs to be treated as first-line in case of mixed urinary incontinence. In elderly women, a careful evaluation of the bladder contractility and comorbidity must be performed. A geriatric evaluation can be necessary. CONCLUSION: Clinical and paraclinical assessment allow to confirm the diagnosis of female ISD, to estimate its severity, and to identify associated mechanisms of incontinence (urethral hypermobility, bladder overactivity) to choose the most adapted treatment.

Physicochemical stability study of a new Trimix formulation for treatment of erectile dysfunction.

Currently, severe erectile dysfunction can be treated by intracavernous injections of solutions containing three active ingredients: prostaglandin E1 (PGE1), papaverine and urapidil. Very few data exist on this mixture where phentolamine has been replaced by Urapidil because Phentolamine is not used for this indication in France. The aim of our study was to assess the stability of this formulation and to extend its expiration to permit preparation of batches. Three batches of the preparation containing 15µg/mL PGE1, 15mg/mL of papaverine and 2mg/mL urapidil were made aseptically and then packed in polypropylene syringes stored at 4°C. The physico-chemical stability has been tested as follows: HPLC stability-indicating method, visual observation, measurement of pH and osmolarity. We found that the limiting factor was PGE1 and we exceeded the threshold of 10% loss after 55 days. Replacement of Urapidil by Phentolamine seems to have a slight detrimental effect on stability. Nevertheless, these results allow us to consider the advance preparation of this formulation and provide quality treatment to these patients by avoiding too frequent visits to the hospital.

[Oncological outcome of radical cystectomy for BCG failure compared to primary invasive disease]. / Résultats oncologiques de la cystectomie pour carcinome urothélial résistant au BCG comparés aux tumeurs invasives d'emblée.

INTRODUCTION AND OBJECTIVES: BCG therapy deeply modified prognosis of high-risk non muscle invasive (NMI) urothelial carcinomas. However, these tumors remain potentially lethal. The objective of this study was to compare oncological outcome of radical cystectomy (RC) for BCG failure to primary invasive (PI) tumors. MATERIAL AND METHODS: RC performed between 2001 and 2011 were retrospectively reviewed. Clinicopathological and follow-up data were compared between RC performed for: NMI high-grade recurrence under BCG therapy (ReNMI); MI recurrence (≥ T2) under BCG therapy (ReMI); primary invasive tumors (PI). The three groups were defined according to tumor status on last TUR before RC. All NMI high-grade bladder tumors at diagnosis had maintenance BCG immunotherapy. RESULTS: Two hundred patients were included, 155 PI, 21 ReNMI et 24 ReMI. Median follow up was 42 months (1.74-135.9). Mean BCG instillations number was 8 ± 4.2 versus 9.5 ± 4.3 for ReNMI and ReMI respectively (P=0.24). Upstaging (≥ pT2) occurred in 33% of ReNMI. The rate of pN+ was 24%, 42% and 30% for the ReNMI, ReMI et PI respectively (P=0.39). No differences were observed between the groups for lymphovascular invasion, extracapsular extension if pN+, soft tissue surgical margins and adjuvant chemotherapy. 5-year cancer specific survival (CSS) was 48% for the ReNMI, 18% for the ReMI and 47% for the PI (P=0.02). Progression to muscle invasion under BCG therapy was an independent pejorative prognostic factor for CSS (P=0.05). CONCLUSION: BCG failure led to poor prognosis, particularly when tumors progressed to muscle invasion. Recurrent NMI high-grade tumors seemed to have comparable prognosis than PI tumors because of the high amount of upstaging and nodal invasion. BCG failure is a therapeutic emergency.