Publications by authors named "François Kleinclauss"

58 Publications

Silicone-hydrocoated ureteral stents encrustation and biofilm formation after 3-week dwell time: results of a prospective randomized multicenter clinical study.

World J Urol 2021 Mar 10. Epub 2021 Mar 10.

GRC n°20, Groupe de Recherche Clinique Sur la Lithiase Urinaire, Hôpital Tenon, Sorbonne Université, 75020, Paris, France.

Objective: To explore the risk of encrustation and biofilm formation for silicone ureteral stents compared to percuflex polymer stents, through a randomized multicenter study.

Patients And Methods: Design, setting and participants: A Multicenter, prospective, randomized, single blind, comparative study of hydrocoated silicone stent (Coloplast Imajin hydro) versus Percuflex™ Plus stent (Boston Scientific), in 141 patients treated by flexible URS for a kidney stone. The study had ethical committee approval in the respective hospitals. Outcome measurements and statistical analysis: Endpoints related to encrustation were biofilm formation and mineral encrustation after a period of 3-week indwelling time. They were evaluated at removal through a scoring scale of ureteral stents encrustation, infrared spectroscopy and optical microscopy of inner and outer surfaces of tips, angles and along the stent's body. Comparison was performed using ANOVA.

Results: 119 stents were available after removal for analysis, 56 in the silicone and 63 in the Percuflex TM Plus group. Mean dwelling duration was 21.8 days for silicone, 22.1 days for PercuflexTM Plus. There was significantly more biofilm on Percuflex™ Plus compared to silicone (1.24 ± 0.08 vs 0.93 ± 0.09, p = 0.0021), and more mineral encrustation (1.22 ± 0.10 vs 0.78 ± 0.11, p = 0.0048), respectively.

Conclusions: This multicenter randomized study shows that silicone-hydrocoated stents are less prone to encrustation than PercuflexTM Plus after a 3-week dwelling period and confirms the low encrustation potential of silicone.
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http://dx.doi.org/10.1007/s00345-021-03646-0DOI Listing
March 2021

Apalutamide, darolutamide and enzalutamide in nonmetastatic castration-resistant prostate cancer: a meta-analysis.

Future Oncol 2021 May 5;17(14):1811-1823. Epub 2021 Feb 5.

Department of Urology, Hôpital Foch, University of Paris-Saclay, Versailles Saint-Quentin-en-Yvelines, Suresnes, France.

Comparison of the efficacy/safety/health-related quality of life of apalutamide, enzalutamide and darolutamide in Phase III clinical trials involving patients with nonmetastatic castration-resistant prostate cancer was performed. Relevant studies were identified by searching PubMed as well as conference abstracts reporting updated overall survival. Three pivotal trials were identified, SPARTAN (apalutamide), PROSPER (enzalutamide) and ARAMIS (darolutamide), and form the basis of this analysis. All three drugs significantly prolonged metastasis-free survival, prostate-specific antigen response and overall survival versus placebo, and were generally well tolerated. Drug selection will likely be influenced by tolerability/safety and other factors, such as the propensity for drug-drug interactions and the presence of comorbidities, that affect the risk-benefit balance in individual patients.
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http://dx.doi.org/10.2217/fon-2020-1104DOI Listing
May 2021

Reply by Authors.

J Urol 2020 10 28;204(4):777. Epub 2020 Jul 28.

Sorbonne Université, Service d'Urologie, AP-HP, Hôpital Tenon, Paris, France.

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http://dx.doi.org/10.1097/JU.0000000000001098.03DOI Listing
October 2020

Evaluation and comparison of scoring systems for predicting stone-free status after flexible ureteroscopy for renal and ureteral stones.

PLoS One 2020 6;15(8):e0237068. Epub 2020 Aug 6.

Department of Urology and Renal Transplantation, University Hospital of Besancon, Besancon, France.

Objective: To evaluate four predictive scores for stone-free rate (SFR) after flexible ureterorenoscopy (f-URS) with holmium-YAG laser fragmentation of renal and ureteral lithiasis.

Methods: We carried out a retrospective analysis of 800 f-URS procedures performed in our institution between January 2009 and December 2016. For each procedure, a single surgeon calculated the following scores: S.T.O.N.E score; Resorlu Unsal Stone Score (RUSS); modified Seoul National University Renal Complexity (S-ReSC) score; and Ito's score.

Results: Overall SFR was 74.1%. Univariate analysis demonstrated that stone size (p<0.0001), stone volume (p<0.0001), stone number (p = 0.004), narrow lower pole infundibulopelvic angle (IPA) (p = 0.003) and lower pole location + IPA <45° (p = 0.011) were significantly associated with SFR. All scores differed between the stone-free and non-stone-free groups. Area under the curve of the receiving operator characteristics curve was calculated for each score: 0.617 [95%CI: 0.575-0.660] for the S.T.O.N.E score; 0.644 [95%CI: 0.609-0.680] for the RUSS; 0.651 [95%CI: 0.606-0.697] for the S-ReSC score; and 0.735 [95%CI: 0.692-0.777] for Ito's nomogram.

Conclusion: All four scores were predictive of SFR after f-URS. Ito's score was the most sensitive. However, the performance of all scores in this analysis was lower than in developmental studies.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0237068PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7410314PMC
October 2020

Effects of Obesity on Postoperative Complications and Graft Survival After Kidney Transplantation.

Transplant Proc 2020 Dec 1;52(10):3153-3159. Epub 2020 Jun 1.

Service d'Urologie, Andrologie et Transplantation Rénale, CHU Besançon, France; Université de Franche-Comté, Besançon, France.

Objective: The objective of this study was to analyze the effects of obesity on postoperative complications and patient and graft survival after kidney transplantation.

Methods: We retrospectively included 506 patients who received a kidney transplant in our center during eleven years. Obesity was defined by a body mass index ≥ 30 kg/m based on World Health Organization criteria. Using univariate and multivariate analyses, we evaluated the impact of obesity on surgical complications according to the Clavien-Dindo classification up to 30 days after surgery. The impact of obesity on graft and patient survival was assessed using a Cox proportional regression model.

Results: Seventy-one patients were obese (14%), and mean follow-up was 63.1 months (59.7-66.5). By multivariable analysis, obesity was associated with delayed graft function (hazard ratio [HR] = 2.60 [1.31-5.02], P = .004). Obesity was not associated with surgical complications, but cardiovascular history was (HR = 1.68 [1.09-2.99], P = .048). By Cox regression analysis, obesity was significantly associated with a higher risk of graft loss (HR = 1.55 [1.06-2.99], P = .042) but not with patient survival (HR = 1.82 [0.88-3.79], P = .106).

Conclusion: Obesity was associated with delayed graft function and graft loss. However, it was not associated with surgical complications. Kidney transplantation remains the best therapy for obese patients suffering from end-stage renal disease, despite shorter graft survival.
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http://dx.doi.org/10.1016/j.transproceed.2020.02.178DOI Listing
December 2020

Effects of Silicone Hydrocoated Double Loop Ureteral Stent on Symptoms and Quality of Life in Patients Undergoing Flexible Ureteroscopy for Kidney Stone: A Randomized Multicenter Clinical Study.

J Urol 2020 10 5;204(4):769-777. Epub 2020 May 5.

Sorbonne Université, Service d'Urologie, AP-HP, Hôpital Tenon, Paris, France.

Purpose: We compared the hydrocoated silicone stent (Coloplast Imajin® hydro) to Percuflex™ Plus stent (Boston Scientific) in terms of patient comfort and quality of life after flexible ureteroscopy for stone disease over a 5-week prospective followup.

Materials And Methods: This is a multicenter, single-blind, prospective, randomized trial of 141 patients treated with flexible ureteroscopy for renal stones. Primary outcome was Ureteral Stent Symptom Questionnaire (USSQ) Body Pain Index recorded before Double-J® stent removal at day (D) 20. Secondary endpoints were USSQ scores at intermediate dates (D2, D7, D20) and 2 weeks after stent withdrawal (D35), occurrence of adverse events and stent encrustation.

Results: The trial was completed by 113 (80.1%) patients. Mean (SD) USSQ body pain scores were 25% lower at D20 for the silicone stent at 18.7 (11.4) vs 25.1 (14.2) (p=0.015). No difference in terms of adverse events and safety profile was observed. USSQ urinary symptoms scores at D2, D7 and D20 were lower in the silicone stent group at 26.4 (7.7) vs 31.8 (8.1) at D20 (p <0.001). The use of USSQ self-questionnaires was associated with a limited number of missing or incomplete answers.

Conclusions: The primary results of this large sample prospective randomized controlled study comparing the silicone Imajin hydro stents to the Percuflex Plus stent show that silicone stents are associated with significantly less patient discomfort. We would recommend their use in patients who require stenting for stone disease.
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http://dx.doi.org/10.1097/JU.0000000000001098DOI Listing
October 2020

De novo renal carcinoma arising in non-functional kidney graft: a national retrospective study.

Int Urol Nephrol 2020 Jul 27;52(7):1235-1241. Epub 2020 Feb 27.

Department of Urology and Renal Transplantation, CHU de Caen, Urology and Transplantation, Avenue de La Côte de Nacre, 14000, Caen, France.

Aim: Characteristics of renal carcinoma arising in non-functional graft in renal transplant recipients (RTR) are unknown. We studied a large national retrospective cohort to analyze circumstances of diagnosis, treatment and outcome compared to the literature.

Methods: Study included all RTR presenting with kidney graft tumors irrespective of the histology, except those with lymphoma and including those tumors arising in non-functional renal graft. Between January 1988 and December 2018, 56,806 patients had renal transplantation in the 32 centers participating in this study. Among this cohort, 18 renal graft tumors were diagnosed in non-functional grafts.

Results: The median patient age at the time of diagnosis was 42.1 years (31.7-51.3). Median age of kidney grafts at the time of diagnosis was 56.4 (23.2-63.4). Eight (44.4%) tumors were discovered fortuitously on renal graft histologic analysis. Fourteen tumors (77.8%) were papillary carcinomas. Two patients had clear cell carcinomas and one patient had a pTa high-grade multifocal urothelial carcinoma in the graft of the upper tract with an in situ carcinoma.

Conclusion: Renal carcinomas in non-functional grafts are rare entities and most of them are diagnosed fortuitously. Despite the fact that these tumors are small, low grade and with a good prognosis, regular monitoring of non-functional grafts should be performed with at least an annual ultrasonography.
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http://dx.doi.org/10.1007/s11255-020-02422-0DOI Listing
July 2020

[Relapse surveillance of patients with testicular germ cell tumor].

Bull Cancer 2019 Oct 5;106(10):903-914. Epub 2019 Sep 5.

CHU de Besançon, oncologie, 25030 Besançon cedex, France; Inserm, UMR1098, 25020 Besançon cedex, France; Université de Franche-Comté, UMR1098, SFR IBCT, 25020 Besançon, France.

Germ-cell tumors are the most common solid tumors in young men. The follow-up of these patients is very important in their management. In stage I testicular cancer, surveillance is the standard for low-risk disease. In addition to the early detection of relapse, follow-up should be directed towards prevention, detection and treatment of late toxicity, and secondary malignancies. Follow up consists in physical examination, laboratory analysis and radiological imaging. Recently, guidelines recommend risk-adapted surveillance strategy, with a reduction of CT scans numbers, due to the recognition of the risk of ionizing radiation exposure. However, efforts to maintain adequate compliance with follow up are required.
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http://dx.doi.org/10.1016/j.bulcan.2019.06.006DOI Listing
October 2019

[Sexual dysfunctions of patients treated with orchidectmoy, chemotherapy and retroperitoneal lymphadenectomy, need for systematic andrological care?]

Bull Cancer 2019 Oct 22;106(10):915-922. Epub 2019 May 22.

Centre hospitalier universitaire, Hôtel-Dieu, service d'urologie, 44000 Nantes, France.

Goal: Long-term evaluation of the incidence of sexual dysfunction from patients who were treated by orchidectomy, chemotherapy, and retroperitoneal lymphadenectomy for testicular cancer.

Methods: In 2018, patients who were treated in two academic hospitals by orchiectomy, chemotherapy, and retroperitoneal lymphadenectomy, and were in complete remission, were included. The patients included in this study filled the survey, which covered aspects of their sexuality (the Male Sexual Health Questionnaire) and answered additional questions, which evaluated psychological impact and modification of their sexuality since the management of their cancer.

Results: Twenty patients have been included, 70% of the patients treated for non-seminomatous germ cell tumor. Mean age was 36.4years±12.1 and the average duration of follow-up was 59months±34. Sexual dysfunction was found in 50% of the patients. Only 10% of the patients could preserve satisfying sexual activity during their treatment. Since the end of their treatment, 16%, 21% and 37% of patients respectively declared high libido loss, lower tumescent erections and persistence of anejaculation. In the end, nearly 70% of these patients wished a dedicated consultation with an urologist with subspecialty in andrology, in order to obtain further information during their care course.

Discussion: These patients have shown multicomponent sexual dysfunction. They could benefit from a new healthcare pathway implying early involvement of andrologist network.
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http://dx.doi.org/10.1016/j.bulcan.2019.03.020DOI Listing
October 2019

3D multi-tissue printing for kidney transplantation.

Quant Imaging Med Surg 2019 Jan;9(1):101-106

Department of Musculoskeletal Imaging, CHRU Besancon, 25000 Besancon, France.

The kidneys are among the most commonly transplanted organs in the world. Transplant patients, as a consequence of their kidney disease and other risk factors which make it difficult for the surgeon to perform vascular anastomosis during kidney transplantation, often have numerous arterial calcifications. The preoperative assessment for transplantation includes an abdominal and pelvic CT scan without contrast that allows for the mapping of atheromatous calcification. However, non-contrast enhanced CT is not optimal and the surgeon is obliged to palpate the arteries during the operation to choose the anatomical site of the vascular anastomosis. This technical note reports the development of a new technique of preoperative reproduction of atherosclerotic arteries, owing to advancements in 3D multi-tissue printing technology. We used scans of four patients with varying degrees of calcified atheroma to model and print their arteries for their pre-surgical planning.
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http://dx.doi.org/10.21037/qims.2018.10.16DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6351812PMC
January 2019

Down-regulation of A-FABP predicts non-muscle invasive bladder cancer progression: investigation with a long term clinical follow-up.

BMC Cancer 2018 Dec 10;18(1):1239. Epub 2018 Dec 10.

Department of Pathology, University Hospital of Besançon, F-25000, Besançon, France.

Background: Non-muscle invasive bladder cancers (NMIBC: pTa, pT1) are characterised by a high risk of recurrence and/or progression. Identification of prognostic markers is needed to improve both diagnosis and management of the disease. The aim of this study was to analyse the expression of A-FABP (adipocyte-fatty acid binding protein) and to evaluate its prognostic value in bladder cancer with a long term clinical follow-up.

Methods: A-FABP expression was investigated by immunohistochemistry in 236 tumours (114 pTa, 61 pT1, 61 pT2-4). Immunostaining was classified as negative (absent or weak immunostaining and moderate or strong staining on ≤10% of cells) or positive (moderate or strong staining on > 10% of cells). Event-free survival (EFS) and overall survival (OS) were determined with a 87.3 months median follow-up in the overall cohort. Recurrence-free survival (RFS) and progression-free survival (PFS) were established in NMIBC.

Results: Loss of A-FABP was associated with higher mean age, high stage/grade, and the presence of metastatic lymph nodes. It was correlated with shorter median EFS (17.5 vs 62.5 months; p = 0.001) and mean OS (76.7 vs 154.2 months; p = 0.009) and with higher risk of progression in the pTa/pT1 subgroup (HR, 0.36; 95% CI, 0.13-0.96; p = 0.041) and importantly in the pTa tumours (HR, 0.34; 95% CI, 0.10-0.97; p = 0.045).

Conclusion: These results demonstrated that loss of A-FABP expression following a long follow-up was predictive of pTa and pTa/pT1 progression. Immunohistochemistry on diagnostic biopsy is easy to use and could be of value to help clinicians to propose appropriate treatment for these tumours.
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http://dx.doi.org/10.1186/s12885-018-5137-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6288864PMC
December 2018

Management of bladder tumors

Rev Prat 2017 Dec;67(10):e497

Service d'urologie et de transplantation rénale, CHRU de Besançon, 25030 Besançon Cedex, France.

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December 2017

Bladder tumors

Rev Prat 2017 Dec;67(10):e491-e496

Service d'urologie et de transplantation rénale, CHRU de Besançon, 25030 Besançon Cedex, France.

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December 2017

[Cytoreduction nephrectomy: No future?]

Bull Cancer 2018 Nov 15;105(11):981-984. Epub 2018 Oct 15.

CHU de Besançon, oncologie, boulevard Fleming, 25030 Besançon cedex, France; Inserm, UMR1098, 25020 Besançon cedex, France; Université de Franche-Comté, UMR1098, SFR IBCT, 25020 Besançon, France. Electronic address:

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http://dx.doi.org/10.1016/j.bulcan.2018.08.009DOI Listing
November 2018

Radical Prostatectomy after Vascular Targeted Photodynamic Therapy with Padeliporfin: Feasibility, and Early and Intermediate Results.

J Urol 2019 02;201(2):315-321

Department of Urology, Lyon Sud University Hospital, Lyon.

Purpose: Vascular targeted photodynamic therapy with TOOKAD® is a new therapeutic option for localized prostate cancer management. The objectives of this study were to assess the feasibility of radical prostatectomy after vascular targeted photodynamic therapy and describe functional and oncologic outcomes.

Materials And Methods: We retrospectively included in study 45 patients who underwent salvage radical prostatectomy after vascular targeted photodynamic therapy for recurrent prostate cancer at a total of 14 surgical centers in Europe between October 2008 and March 2017. Of the 42 radical prostatectomies performed 16 were robot-assisted, 6 were laparoscopic and 20 were open surgery. Primary end points were morbidity and technical difficulties. Secondary end points were early and intermediate postoperative functional and oncologic outcomes.

Results: Median operative time was 180 minutes (IQR 150-223). Median blood loss was 200 ml (IQR 155-363). According to the surgeons the surgery was easy in 29 patients (69%) and difficult in 13 (31%). Nerve sparing was feasible in 14 patients (33%). Five postoperative complications (12%) were found, including 2 Clavien I, 2 Clavien II and 1 Clavien IIIB complications. Of the cases 13 (31%) were pT3 and 21 (50%) were pT2c. Surgical margins were positive in 13 patients (31%). Prostate specific antigen was undetectable at 6 to 12 months in 37 patients (88%). Nine patients underwent complementary radiotherapy. Four patients had final prostate specific antigen greater than 0.2 ng/ml at a median followup of 23 months (IQR 12-36). At 1 year 27 patients (64%) were completely continent (no pads) and 10 (24%) had low incontinence (1 pad). Four patients (11%) recovered potency without treatment and 23 (64%) recovered potency with appropriate treatment.

Conclusions: Salvage radical prostatectomy after vascular targeted photodynamic therapy treatment was feasible and safe without difficulty for most of the surgeons.
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http://dx.doi.org/10.1016/j.juro.2018.08.084DOI Listing
February 2019

Testicle-sparing surgery versus radical orchiectomy in the management of Leydig cell tumors: results from a multicenter study.

World J Urol 2018 Mar 11;36(3):427-433. Epub 2017 Dec 11.

Department of Urology and Renal Transplantation, University Hospital of Besancon, 3 Boulevard Fleming, 25000, Besancon, France.

Objective: To compare the oncological outcomes of testicle-sparing surgery (TSS) and radical orchiectomy (RO) in patients with Leydig cell tumor (LCT) of the testis.

Patients And Methods: A multicenter retrospective clinical study was conducted in 12 centers in France. All the patients with histologically proven LCT were included and analyzed according to treatment (organ-sparing surgery or radical orchiectomy). Patients underwent preoperative clinical, biological and imaging assessment. Demographic, clinical, and pathological variables were collected at baseline and compared between groups according to surgical treatment. Follow-up was calculated using the reverse Kaplan-Meier estimation and was updated at the end of 2015.

Results: Between 1986 and 2014, 56 patients presented with LCT were identified and included in the study. Twenty-one patients (37.5%) underwent TSS and 35 (62.5%) RO. Demographics and tumor characteristics were not significantly different between the groups. Median follow-up was 62 months after TSS, but only 35 months after RO. Two patients (9.5%) developed local recurrence 15 and 34 months after TSS and underwent secondary RO. No local recurrence or metastasis was observed after complementary treatment. No recurrence was observed after RO. Disease-free survival did not differ between the groups (95.2% in TSS versus 77.1% in the RO group, p = 0.23). No patient died in the TSS group, but three patients (8.6%) in the RO group died from other diseases without evidence of relapse. One patient (4.8%) in the TSS group versus five (14.3%) in the RO group were lost to follow-up.

Conclusion: Long-term follow-up suggests that testicle-sparing surgery does not compromise relapse-free survival in the treatment of Leydig cell tumor of the testis.
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http://dx.doi.org/10.1007/s00345-017-2151-0DOI Listing
March 2018

Padeliporfin vascular-targeted photodynamic therapy versus active surveillance in men with low-risk prostate cancer (CLIN1001 PCM301): an open-label, phase 3, randomised controlled trial.

Lancet Oncol 2017 Feb 20;18(2):181-191. Epub 2016 Dec 20.

Division of Surgery and Interventional Science, University College London, London, UK. Electronic address:

Background: Vascular-targeted photodynamic therapy, a novel tissue-preserving treatment for low-risk prostate cancer, has shown favourable safety and efficacy results in single-arm phase 1 and 2 studies. We compared this treatment with the standard of care, active surveillance, in men with low-risk prostate cancer in a phase 3 trial.

Methods: This randomised controlled trial was done in 47 European university centres and community hospitals. Men with low-risk, localised prostate cancer (Gleason pattern 3) who had received no previous treatment were randomly assigned (1:1) to vascular-targeted photodynamic therapy (4 mg/kg padeliporfin intravenously over 10 min and optical fibres inserted into the prostate to cover the desired treatment zone and subsequent activation by laser light 753 nm with a fixed power of 150 mW/cm for 22 min 15 s) or active surveillance. Randomisation was done by a web-based allocation system stratified by centre with balanced blocks of two or four patients. Best practice for active surveillance at the time of study design was followed (ie, biopsy at 12-month intervals and prostate-specific antigen measurement and digital rectal examination at 3-month intervals). The co-primary endpoints were treatment failure (histological progression of cancer from low to moderate or high risk or death during 24 months' follow-up) and absence of definite cancer (absence of any histology result definitely positive for cancer at month 24). Analysis was by intention to treat. Treatment was open-label, but investigators assessing primary efficacy outcomes were masked to treatment allocation. This trial is registered with ClinicalTrials.gov, number NCT01310894.

Findings: Between March 8, 2011, and April 30, 2013, we randomly assigned 206 patients to vascular-targeted photodynamic therapy and 207 patients to active surveillance. Median follow-up was 24 months (IQR 24-25). The proportion of participants who had disease progression at month 24 was 58 (28%) of 206 in the vascular-targeted photodynamic therapy group compared with 120 (58%) of 207 in the active surveillance group (adjusted hazard ratio 0·34, 95% CI 0·24-0·46; p<0·0001). 101 (49%) men in the vascular-targeted photodynamic therapy group had a negative prostate biopsy result at 24 months post treatment compared with 28 (14%) men in the active surveillance group (adjusted risk ratio 3·67, 95% CI 2·53-5·33; p<0·0001). Vascular-targeted photodynamic therapy was well tolerated. The most common grade 3-4 adverse events were prostatitis (three [2%] in the vascular-targeted photodynamic therapy group vs one [<1%] in the active surveillance group), acute urinary retention (three [2%] vs one [<1%]) and erectile dysfunction (two [1%] vs three [1%]). The most common serious adverse event in the vascular-targeted photodynamic therapy group was retention of urine (15 patients; severe in three); this event resolved within 2 months in all patients. The most common serious adverse event in the active surveillance group was myocardial infarction (three patients).

Interpretation: Padeliporfin vascular-targeted photodynamic therapy is a safe, effective treatment for low-risk, localised prostate cancer. This treatment might allow more men to consider a tissue-preserving approach and defer or avoid radical therapy.

Funding: Steba Biotech.
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http://dx.doi.org/10.1016/S1470-2045(16)30661-1DOI Listing
February 2017

Flexible Ureterorenoscopy for Renal and Proximal Ureteral Stone in Patients with Previous Ureteral Stenting: Impact on Stone-Free Rate and Morbidity.

J Endourol 2016 10 19;30(10):1084-1088. Epub 2016 Sep 19.

1 Department of Urology and Renal Transplantation, University Hospital of Besançon , Besançon, France .

Objective: To analyze results (stone-free rate [SFR]) and complications after flexible ureterorenoscopy (f-URS) for renal or lumbar ureteral lithiasis in patients with a previous ureteral stenting (US).

Patients And Methods: We conducted a single-center retrospective study, including all f-URS procedures achieved in our department, between January 2004 and December 2010, for renal or lumbar ureteral urinary lithiasis. In total, 497 procedures were performed: 316 procedures in patients with a ureteral stent placed before the surgery for renal colic, sepsis, or renal failure (group 1) and 181 procedures in patients without US (group 2). Success was defined as a complete SFR at 6-month follow-up. Surgical morbidity was defined using the Clavien-Dindo grading system.

Results: Groups 1 and 2 were well balanced in terms of demographic data, number, and size of stones. Ureteral location was significantly higher in group 1 (30.2% vs 16.3%, p = 0.0006). Surgery characteristics were similar in both groups. By univariate analysis, SFR tended to be slightly higher in the group with prior ureteral stenting (72% vs 63%, p = 0.05). SFR for ureteral location was also higher after previous ureteral stenting (81.5% vs 59.4%, p = 0.023). By multivariate analysis, only stone size and number were correlated with f-URS failure. Complication rate was comparable in both groups (10.7% vs 11.8%, p = 0.7).

Conclusion: Technical aspects of the f-URS procedure were not modified by ureteral stenting. We found that f-URS in patients with ureteral stenting was not associated with a better SFR, except in case of ureteral location in univariate analysis. Ureteral stenting was not independently related to f-URS outcome by multivariate analysis.
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http://dx.doi.org/10.1089/end.2016.0045DOI Listing
October 2016

CT-guided paravertebral block for microwave ablation of kidney tumors: a new technique.

Abdom Radiol (NY) 2016 06;41(6):1197-202

Department of Radiology, University Hospital of Besancon, 25000, Besançon, France.

Purpose: In patients undergoing computed tomography (CT)-guided microwave ablation (MWA) for renal tumors, we developed a CT-guided anterior paravertebral block (PVB) associated with anesthesia of the kidney capsule and inhalation of an equimolar mixture of oxygen and nitrous oxide (EMONO). The primary objectives were to describe our technique and to study its efficacy in terms of procedural success. The secondary objective was to study the tolerance by evaluating patient pain scores and the number of complications.

Methods: Patients suffering from renal carcinoma classified T1a and considered to be poor candidates for surgery were included in this prospective, single-center pilot study. They underwent MWA under CT-guided loco-regional anesthesia: an anterior variant of the PVB at the level of T10, ipsilateral to the renal MWA associated with anesthesia of the kidney capsule and EMONO. Technical success was defined as total thermal ablation without additional sedation and no side effect during the procedure. Maximal pain score during the procedure was assessed using a visual analog score.

Results: Four patients were included. All procedures were technical success. No side effects were reported, either due to the procedure or anesthesia. The maximal pain score recorded immediately after procedure was 2 ± 2.4 on the visual analog score.

Conclusions: MWA of the kidney is feasible under CT-guided anterior paravertebral block. PVB is well tolerated and can be associated with anesthesia of the kidney capsule and EMONO. This new technique may be an alternative to general anesthetic or conscious sedation in clinical practice.
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http://dx.doi.org/10.1007/s00261-016-0738-3DOI Listing
June 2016

Endoscopic lithotripsy and vaginal excision of a calcified bladder-mesh extrusion.

Int Urogynecol J 2016 Jul 6;27(7):1113-5. Epub 2016 Jan 6.

Pôle Mère-Femme, Besancon University Medical Centre, 3 Alexander Fleming boulevard, 25030, Besançon, France.

Introduction And Hypothesis: Synthetic meshes have proven to increase efficacy of pelvic organ prolapse (POP) repair, but associated complications are not rare. Bladder mesh extrusion is one of the most serious adverse events following POP surgery with mesh. The aim of this video was to describe endoscopic and vaginal approaches for treating a bladder-mesh extrusion.

Methods: A 52-year-old female patient with a history of vaginal POP surgery with mesh was referred for severe pelvic and perineal pain, dyspareunia, and dysuria. She was found to have a bladder calculus on a mesh extrusion. The calculus was removed by endoscopic lithotripsy before vaginal mesh excision was performed.

Conclusions: With the use of synthetic vaginal mesh, the incidence of bladder-mesh extrusion could increase. This didactic video will be helpful to surgeons required to manage such cases using a minimally invasive treatment.
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http://dx.doi.org/10.1007/s00192-015-2934-zDOI Listing
July 2016

Nephrectomy improves overall survival in patients with metastatic renal cell carcinoma in cases of favorable MSKCC or ECOG prognostic features.

Urol Oncol 2015 Aug 16;33(8):339.e9-15. Epub 2015 Jun 16.

Department of Urology, Bicetre Hospital, Paris XI University, Le Kremlin Bicêtre, France.

Objectives: The role of cytoreductive nephrectomy (CN) in the treatment of patients harboring metastatic renal cell carcinoma (mRCC) has become controversial since the emergence of effective targeted therapies. The aim of our study was to compare the overall survival (OS) between CN and non-CN groups of patients presenting with mRCC in the era of targeted drugs and to assess these outcomes among the different Memorial Sloan-Kettering Cancer Center (MSKCC) and The Eastern Cooperative Oncology Group (ECOG) performance status subgroups.

Methods And Materials: A total of 351 patients with mRCC at diagnosis recruited from 18 tertiary care centers who had been treated with systemic treatment were included in this retrospective study. OS was assessed by the Kaplan-Meier method according to the completion of a CN. The population was subsequently stratified according to MSKCC and ECOG prognostic groups.

Results: Median OS in the entire cohort was 37.1 months. Median OS was significantly improved for patients who underwent CN (16.4 vs. 38.1 months, P<0.001). However, subgroup analysis demonstrated that OS improvement after CN was only significant among the patients with an ECOG score of 0 to 1 (16.7 vs. 43.3 months, P = 0.03) and the group of patients with good and intermediate MSKCC score (16.8 vs. 42.4 months, P = 0.02). On the contrary, this benefit was not significant for the patients with an ECOG score of 2 to 3 (8.0 vs. 12.6 months, P = 0.8) or the group with poor MSKCC score (5.2 vs. 5.2, P = 0.9).

Conclusions: CN improves OS in patients with mRCC. However, this effect does not seem to be significant for the patients in ECOG performance status groups of 2 to 3 or poor MSKCC prognostic group.
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http://dx.doi.org/10.1016/j.urolonc.2015.05.014DOI Listing
August 2015

Comparison of the efficacy and morbidity of flexible ureterorenoscopy for lower pole stones compared with other renal locations.

J Endourol 2014 Oct 12;28(10):1183-7. Epub 2014 Sep 12.

1 Department of Urology and Renal Transplantation, University Hospital of Besançon , France .

Background And Purpose: Flexible ureterorenoscopy (f-URS) for lower pole stones (LPS) compared with other renal locations can be challenging because of anatomic and technical considerations. We aimed to compare the stone-free rate (SFR) and surgical complication rate with f-URS for LPS vs other renal locations.

Patients And Methods: We performed a retrospective, single-center study including 371 f-URS for renal stone retrieval performed in our institution between January 2004 and December 2010. Among the 371 procedures included in this analysis, 139 were performed for stones located in a single renal location other than the lower pole (group 1), and 232 for at least one stone located in the lower pole (group 2). We compared the efficacy (SFR) and the morbidity of f-URS between the two groups. The success of the procedure was defined as a complete SFR 6 months after f-URS.

Results: Age, sex, history of urolithiasis, body mass index, and preoperative stent placement did not differ between the two groups. No differences in stone characteristics were observed between both groups except stone size under 10 mm that was significantly higher in group 2 (P=0.018). Technical aspects of the procedure did not differ between the groups, except for more frequent use of an access sheath in group 2 (P=0.007). SFR was comparable between groups (P=0.774). The complication rate was similar in both groups, as was the severity of complications. By multivariate analysis, stone size >10 mm (P<0.0001) and multiple stone locations (P=0.001) were associated with f-URS failure, but lower pole location did not impact on SFR.

Conclusion: In our study, stone location, in particular LPS, did not have any impact on efficacy and morbidity of f-URS. Only multiple locations and stone size >10 mm seemed to significantly decrease the SFR, without impacting morbidity.
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http://dx.doi.org/10.1089/end.2014.0286DOI Listing
October 2014

Clinical impact of targeted therapies in patients with metastatic clear-cell renal cell carcinoma.

Onco Targets Ther 2014 27;7:365-74. Epub 2014 Feb 27.

Inserm U645 EA-2284 IFR-133, University of Franche-Comté, Besançon, France ; Department of Medical Oncology, Besançon, France.

Introduction: The aim of this retrospective clinical study was to assess, in the context of the recent evolution of systemic therapies, the potential effect of targeted therapies on overall survival (OS) of patients with metastatic clear-cell renal cell carcinoma (mccRCC) in daily practice.

Patients And Methods: All consecutive patients with histologically confirmed mccRCC who received systemic therapy between January 2000 and December 2010 in two oncology treatment centers in our Franche-Comté region in eastern France were included in the analysis. The primary end point was OS. The analysis of prognostic factors was performed using a two-step approach: univariate then multivariate analysis with a stepwise Cox proportional hazards regression model.

Results: For the entire cohort of 111 patients, the median OS was 17 months (95% confidence interval [CI]; 13-22 months) and the two-year OS was 39%. Three prognostic factors were independent predictors of long survival: prior nephrectomy (hazard ratio =0.38 [0.22-0.64], P<0.0001); systemic therapy by targeted therapy (hazard ratio =0.50 [0.31-0.80], P=0.005); and lack of liver metastasis (hazard ratio =0.43 [0.22-0.82], P=0.002). Median OS was 21 months [14-29 months] for patients who received at least one targeted therapy compared with 12 months [7-15 months] for patients who were treated only by immunotherapy agents (P=0.003).

Conclusion: Our results suggest that targeted therapies are associated with improved OS in comparison with cytokines, which is in line with other publications.
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http://dx.doi.org/10.2147/OTT.S56370DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3942215PMC
March 2014

Clinicopathological characteristics of incidental prostate cancer discovered from radical cystoprostatectomy specimen: a multicenter French study.

Ann Surg Oncol 2014 Feb 30;21(2):684-90. Epub 2013 Oct 30.

Department of Urology, Bicetre Academic Hospital, Paris XI University, Le Kremlin Bicêtre Cedex, France,

Purpose: The present study assessed the incidence and histopathological features of incidentally diagnosed prostate cancer (PCa) in specimens from radical cystoprostatectomy (RCP) for bladder cancer. The patient outcomes also were evaluated.

Methods: We retrospectively reviewed the histopathological features and survival data of 4,299 male patients who underwent a RCP for bladder cancer at 25 French centers between January 1996 and June 2012. No patients had preoperative clinical or biological suspicion of PCa.

Results: Among the 4,299 RCP specimens, PCa was diagnosed in 931 patients (21.7%). Most tumors (90.1%) were organ-confined (pT2), whereas 9.9% of them were diagnosed at a locally advanced stage (≥pT3). Gleason score was <6 in 129 cases (13.9%), 6 in 575 cases (61.7%), 7 (3 + 4) in 149 cases (16.0%), 7 (4 + 3) in 38 cases (4.1%), and >7 in 40 cases (4.3%). After a median follow-up of 25.5 months (interquartile range 14.2-47.4), 35.4% of patients had bladder cancer recurrence and 23.8% died of bladder cancer. Only 16 patients (1.9%) experienced PCa biochemical recurrence during follow-up, and no preoperative predictive factor was identified. No patients died from PCa.

Conclusions: The rate of incidentally diagnosed PCa in RCP specimens was 21.7%. The majority of these PCas were organ-confined. PCa recurrence occurred in only 1.9% of cases during follow-up.
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http://dx.doi.org/10.1245/s10434-013-3340-8DOI Listing
February 2014

Safety and efficacy of cabazitaxel in the docetaxel-treated patients with hormone-refractory prostate cancer.

Clin Med Insights Oncol 2013 20;7:1-12. Epub 2012 Dec 20.

Centre Hospitalier Universitaire Besançon, Oncology, Besançon, France.

Prostate cancer (PC) is one of the most common cancers and is a leading cause of death. Its initial growth is dependent on androgens; most patients show an initial response to hormonal therapy but will experience disease progression when PC becomes resistant to castration. In 2004, two key randomized controlled trials demonstrated a benefit for docetaxel-based regimens in the treatment of men with castration-resistant prostate cancer (CRPC). Cabazitaxel (XRP6258, TXD258, and RPR116258A), a tubulin-binding taxane drug as potent as docetaxel in cell lines, was the first treatment able to prolong survival for metastatic CRPC in the post-docetaxel setting. This review describes pharmacologic parameters of this agent followed by a review of clinical trials involving cabazitaxel. Other available treatments and the place of cabazitaxel in metastatic CRPC setting are discussed.
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http://dx.doi.org/10.4137/CMO.S7256DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3547543PMC
January 2013

Positive surgical margins and their locations in specimens are adverse prognosis features after radical cystectomy in non-metastatic carcinoma invading bladder muscle: results from a nationwide case-control study.

BJU Int 2013 Jun 17;111(8):1253-60. Epub 2013 Jan 17.

Department of Urology, Hopital Foch, Universite De Versailles - Saint-Quentin En Yvelines, Suresnes, France.

Objective: To compare the prognoses associated with positive surgical margins (PSMs) according to their urethral, ureteric and/or soft tissue locations in patients with pN0 M0 bladder cancer who have not undergone neoadjuvant chemotherapy.

Patients And Methods: A retrospective, case-control study was conducted between 1991 and 2011 using data from 17 academic centres in France. A total of 154 patients (cases) with PSMs met the eligibility criteria and were matched according to centre, pT stage, gender, age and urinary diversion method with a population-based sample of 154 patients (controls) from 3651 patients who had undergone cystectomies. The median follow-up period was 23.9 months. Multivariable Cox regression analysis was used to test the effects of PSMs on local recurrence (LR)-free survival, metastatic recurrence (MR)-free survival and cancer-specific survival (CSS).

Results: The 5-year LR-free survival and CSS rates of patients with urethral and soft tissue PSMs were lower than those in the control group. A significant decrease in CSS was associated with soft tissue PSMs (P = 0.003, odds ratio = 0.425, 95% confidence interval 0.283-0.647). The prognosis was not affected in cases of ureteric PSMs.

Conclusions: Soft tissue PSMs were associated with poor CSS rates in patients with pN0 M0 bladder cancer. A correlation between urethrectomy and a reduction of the risk of LR in a urethral PSM setting was observed.
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http://dx.doi.org/10.1111/j.1464-410X.2012.11664.xDOI Listing
June 2013

Renal cell carcinoma (RCC) arising in native kidneys of dialyzed and transplant patients: are they different entities?

BJU Int 2012 Dec 22;110(11 Pt B):E570-3. Epub 2012 Jun 22.

Department of Urology, Félix Guyon University Hospital, Saint-Denis de la Réunion, France.

Unlabelled: What's known on the subject? and What does the study add? Patients with end-stage renal disease (ESRD) have an increased risk of developing RCC in their native kidneys. The prevalence of RCC is 3-4% in cases of ESRD in dialyzed and/or transplanted patients, which corresponds to a rate 100-times higher than that in the general population. This is the first study, to our knowledge, comparing the characteristics of kidney cancer in the ESRD population according to their dialysis or transplantation status at the time of diagnosis. The differences in stage and survival we observed may be due to differences in surveillance strategies between transplanted and not transplanted patients, nevertheless, the differences in pathological subtypes suggest they could also be due to differences in the tumorigenesis process.

Objective: • To compare clinical, pathological and outcome features of renal cell carcinomas (RCCs) arising in patients with chronic renal failure (CRF) with or without renal transplantation.

Patients And Methods: • In all, 24 French University Departments of Urology and Kidney Transplantation participated in this retrospective study comparing RCCs arising in patients with CRF according to their dialysis or transplantation status at the time of diagnosis. • Information about age, sex, symptoms, duration of CRF, mode and duration of dialysis, renal transplantation, tumour staging and grading, histological subtype and outcome were recorded in a unique database. • Qualitative and quantitative variables were compared by using chi-square and Student statistical analysis. Survival was assessed by Kaplan-Meier and Cox methods.

Results: • Data on 303 RCC cases diagnosed between 1985 and 2009 were identified in 206 men (76.3%) and 64 women (23.7%). • Transplanted and not transplanted patients accounted for 213 (70.3%) and 90 cases (29.7%), respectively. • In transplant recipients, RCC was diagnosed at a younger age [mean (sd) 53 (11) vs 61 (14) years, P < 0.001), the mean tumour size was smaller [3.4 (2.3) vs 4.2 (3.1) cm, P= 0.02), pT1a stage (75 vs 60%, P= 0.009) and papillary histological subtype (44 vs 22%, P < 0.001) were more frequent than in their dialysis-only counterparts. • Nodal (1 vs 6%, P= 0.03) and distant metastases rates (0 vs 5%, P < 0.001) were significantly increased in patients who had not had a transplant. However, Fürhman grading, symptoms, tumour multifocality or bilaterality, presence of acquired cystic kidney disease, were not significantly different between the groups. • Estimated 5-year survival rates were 97% and 77% for transplanted and not transplanted patients, respectively (P < 0.001). In univariate analysis, presence of symptoms (P= 0.008), poor performance status (P= 0.04), large tumour size, advanced TNM stage (P < 0.001), high Führman grade (P= 0.005) and absence of transplantation (P < 0.001) were all adverse prognostic factors. In multivariate analysis, only T stage remained an independent predictor for cancer-related death (P < 0.001).

Conclusion: • RCC arising in native kidneys of transplant patients seems to exhibit many favourable clinical, pathological and outcome features compared with those diagnosed in dialysis-only patients. Further research is needed to determine whether it is due to particular molecular pathways or to biases in relation to mode of diagnosis.
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http://dx.doi.org/10.1111/j.1464-410X.2012.11273.xDOI Listing
December 2012

Loss of central and peripheral CD8+ T-cell tolerance to HFE in mouse models of human familial hemochromatosis.

Eur J Immunol 2012 Apr;42(4):851-62

Inserm UMR 645 -IFR133, Université de Franche-Comté, EFS BFC, Besançon, France.

HFE, an MHC class Ib molecule that controls iron metabolism, can be directly targeted by cytotoxic TCR αβ T lymphocytes. Transgenic DBA/2 mice expressing, in a Rag 2 KO context, an αβ TCR that directly recognizes mouse HFE (mHFE) were created to further explore the interface of HFE with the immune system. TCR-transgenic mHfe WT mice deleted mHFE-reactive T cells in the thymus, but a fraction of reprogrammed cells were able to escape deletion. In contrast, TCR-transgenic mice deprived of mHFE molecules (mHfe KO mice) or expressing a C282→Y mutated mHFE molecule - the most frequent mutation associated with human hereditary hemochromatosis - positively selected mHFE-reactive CD8(+) T lymphocytes and were not tolerant toward mHFE. By engrafting these mice with DBA/2 WT (mHFE(+)) skin, it was established, as suspected on the basis of similar engraftments performed on DBA/2 mHfe KO mice, that mHFE behaves as an autonomous skin-associated histocompatibility antigen, even for mHFE-C282→Y mutated mice. By contrast, infusion of DBA/2 mHFE(+) mice with naïve mHFE-reactive transgenic CD8(+) T lymphocytes did not induce GVHD. Thus, tolerance toward HFE in mHfe WT mice can be acquired at either thymic or peripheral levels but is disrupted in mice reproducing human familial hemochromatosis.
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http://dx.doi.org/10.1002/eji.201141664DOI Listing
April 2012

[Immunotherapy: an emerging strategies against prostate castration resistant cancer].

Bull Cancer 2012 Jul;99 Suppl 1:S57-65

CHU Jean-Minjoz, oncologie médicale, boulevard Flemming, 25000 Besançon, France.

Castration resistant prostate cancer occurs when patients experience disease progression despite appropriate hormonal manipulations. In these patients, chemotherapy remains standard treatment. Preclinical and clinical data have demonstrated the potential utility of an immunotherapy-based approach for the treatment of prostate cancer (PC). The phase III trial (IMPACT) has recently reported an advantage for Sipuleucel-T over placebo, with an overall survival 4.1 months superior to placebo. Sipuleucel-T is also the first FDA-approved immunotherapy for prostate cancer. These promising results need to be confirmed with other large studies and within previous step of PC. Neoplasic cells can escape immune responses by multiple mechanisms. A better knowledge of these mechanisms is of major concern for the future development of new immunotherapies approach.
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http://dx.doi.org/10.1684/bdc.2012.1564DOI Listing
July 2012

Ureterorenoscopy with holmium-yttrium-aluminum-garnet fragmentation is a safe and efficient technique for stone treatment in patients with a body mass index superior to 30 kg/m2.

J Endourol 2012 Mar 12;26(3):239-43. Epub 2012 Jan 12.

Dept. of Urology and Renal Transplantation, University Hospital Saint-Jacques, Besançon, France.

Purpose: The aim of the study was to analyze results and morbidity after flexible ureterorenoscopy in patients with a body mass index (BMI) >30 kg/m(2) and to compare with results obtained in a large cohort of nonobese patients.

Patients And Methods: We conducted a retrospective study including all flexible ureterorenoscopy performed for stone retrieval in our institution between January 2004 and December 2008. During the study period, 224 procedures were performed, of which 18 had to be excluded because of missing BMI data. Thus, a total of 206 procedures were included in the final analysis (34 in 29 obese patients, 172 in 149 nonobese patients). Characteristics of the patients (age, BMI, previous treatment), stones (nature, location, number), and procedures (operating time, morbidity, outcome) were analyzed. Success was defined as clear imaging (completely stone free) on renal tomography and ultrasonography at 1, 3, and 6 months follow-up.

Results: Mean BMI was 34±0.6 kg/m(2) in obese patients (OP) and 24±0.2 kg/m(2) in nonobese patients (NOP). Mean stone size, location, and composition were not significantly different between groups. Operative time was also similar in OP and NOP (102.5±6.1 min vs 103±3.4 min, P=NS). The rate of minor complications (fever, hematuria, flank pain) was similar in OP (11.8%) and NOP (11.4%). No major complication necessitating prolonged hospital stay or new surgical procedure was observed. The overall stone-free rate was not significantly different between OP (79.4%) and NOP (70%).

Conclusion: Flexible ureterorenoscopy is an appropriate treatment for use in obese patients and achieves excellent stone-free rates with low morbidity.
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http://dx.doi.org/10.1089/end.2011.0391DOI Listing
March 2012