New TENSI+ Device for Transcutaneous Posterior Tibial Nerve Stimulation: A Prospective, Multicentre, Post-market Clinical Study.

BACKGROUND AND OBJECTIVE: Our aim was to report the first clinical trial of TENSI+, a new device for transcutaneous posterior tibial nerve stimulation (TNS) for treatment of overactive bladder (OAB). METHODS: A prospective, multicentre clinical trial was conducted in adults with OAB in seven French centres. The main exclusion criteria were prior percutaneous or transcutaneous TNS or invasive OAB treatment, current antimuscarinic use, 24-h polyuria, known bladder disease, postvoid residual volume >150 ml, and pelvic organ prolapse stage >2. Patients self-administered daily TTNS sessions of 20 min with TENSI+ at home after education by a specialized nurse. A bladder diary, Urinary Symptom Profile and OAB-q questionnaires, and Patient Global Impression of Improvement (PGI-I) scores were evaluated at baseline and 3 and 6 mo. The primary endpoint was efficacy, based on PGI-I and variations in bladder diary parameters. Success was defined as a PGI-I score ≤3 and any improvement ≥30% in bladder diary parameters. KEY FINDINGS AND LIMITATIONS: The study included 78 patients (13 males). Nine patients had neurological disease, 21 had previously tried antimuscarinics, and 41 had wet OAB at baseline. At 3 mo, 65/78 patients had a full analysis set. Treatment was successful in 44/65 patients (67%), with 25/65 (38%) reporting both an objective improvement and high satisfaction. All OAB-related endpoints were significantly improved, except bladder capacity and total voided volume per 24 h. At 6 mo, only five of 44 patients had interrupted their treatment. No factor predictive of success was identified. Two adverse events (pain at stimulation site and/or pelvic pain) were reported and spontaneously resolved without treatment interruption. CONCLUSIONS AND CLINICAL IMPLICATIONS: TENSI+ is a safe and effective TTNS treatment option for OAB management. PATIENT SUMMARY: TENSI+ is a new device for nerve stimulation in patients with overactive bladder. Patients use the device at home every day. In our short-term trial, TENSI+ use improved symptoms in 67% of patients. Further evaluation over a longer period of time is needed.

Efficacy and safety of the TENSI+ device for posterior tibial nerve stimulation: A multicenter, retrospective study.

OBJECTIVES: Transcutaneous posterior tibial nerve stimulation (TC-PTNS) is a validated option for lower urinary tract symptoms (LUTS) management, with a short-term success rate of around 60% and few adverse events. Our goal was to report the efficacy and safety results of TC-PTNS using the newly issued device TENSI+ for LUTS management. PATIENTS AND METHODS: A multicenter, retrospective study was conducted in 7 urology departments in France. All patients treated with TC-PTNS for LUTS using the TENSI+ device between September 2021 and February 2022 were included. All patients received supervised at-home training by a specialized nurse. All patients were asked to do daily, 20minutes sessions of TC-PTNS. Patient demographics, history, initial symptoms and previous treatment were collected at inclusion. A follow-up visit was scheduled at 3 months. Efficacy was evaluated through treatment persistence at 3 months and PGI-I (Patient Global Impression of Improvement) score. Adverse events were recorded. RESULTS: One hundred and three patients (86 women and 17 men) were included. All patients had overactive bladder symptoms, 64 suffered from urgency incontinence, and 24 had associated voiding symptoms. Eighteen patients had neurogenic background, and 30 previously received anticholinergics. After a median follow-up of 12 [10-21]weeks, 70 patients were still using the device (68%). PGI-I score reflected an improvement in 70.9% and was 1, 2 and 3 in 28, 26 and 19 patients respectively, while 24 were unchanged and 6 were worse. No clinical baseline parameter was predictive of success. Adverse events included pain at stimulation site (two cases) and pelvic pain (two patients), which rapidly resolved after treatment interruption. CONCLUSIONS: TC-PTNS with TENSI+ device is an effective option for LUTS management, with results that seem similar to other TC-PTNS approaches. Adverse events were mild and reversible after treatment interruption.

[Multidisciplinary meetings in pelvic floor disease in women: A national survey by the CUROPF among French urologists]. / Réunion de concertation pluridisciplinaire en pelvipérinéologie en France : résultats d'une enquête nationale du CUROPF auprès des urologues français.

INTRODUCTION: Multidisciplinary team meetings (MTMs) in the field of pelvic floor diseases in women tend to generalize, as they are required as mandatory before mid-urethral sling implantation or sacrocolpopexy by recent decrees published by the French health authorities. However, access to these meetings is variable in the French territory. The goal of the present study was to describe the existence and the settings of these kinds of meetings in France. MATERIEL AND METHODS: An on-line survey was conducted between June and July 2020 (stage 1) then between November 2021 and January 2022 (stage 2). A 15-item questionnaire was sent to all members of the Association française d'urologie (AFU). A descriptive analysis was conducted. RESULTS: Three hundred and twenty-two completed questionnaires were sent back during stage 1 and 158 during stage 2. Early 2022, 61.3% of respondents had access to a pelviperineology MTM, with important difference according to geographical areas. Main activity of MTMs was case discussion of complex situations (68% of meetings). At the end of 2021, 22% of the respondents declared willing to stop partially or totally their pelviperineology activity, given the new regulations set in place by the authorities. CONCLUSION: Despite being absolutely mandatory in current clinical practice, MTMs in pelvic floor disease have spread slowly. MTMs implementation was still insufficient in 2022, and variable on the French territory. Some urologists declare having no access to such resources and about 1 out of 5 were considering to voluntary stop of decrease significantly their activity in this difficult context.

1,000 Retroperitoneoscopic Procedures of the Upper Urinary Tract: Analysis of Complications.

BACKGROUND AND OBJECTIVE: To evaluate risk factors and complications of retroperitoneoscopic procedures of upper urinary tract and adrenal gland. METHODS: From 1994 to 2016, 1,000 retroperitoneal laparoscopies were performed - 476 nephrectomies, 201 adrenalectomies, 103 partial nephrectomies, 91 pyeloplasties, 70 nephro-ureterectomies, and 59 miscellaneous surgeries (diverticulectomy). Data collection was prospective. We analyzed age, body mass index (BMI), American Society of Anesthesiologists (ASA) score, operative time, blood loss, hospitalization stay and complications. Risks factors were explored with univariate and multivariate analysis. RESULTS: The mean BMI was 25 and median ASA 2. The mean operative time was 136 mn, mean blood loss 149 mL. There were 49 conversions. Of the patients, 41 required re-interventions, predominantly due to urinary fistula or post-operative bleeding. Post-operatively, 145 complications were recorded. In multivariate analysis, partial nephrectomies (OR 2.12, p = 0.031, 95% CI [1.07-4.22]) and pyeloplasties (OR 1.97, p = 0.02, 95% CI [1.11-3.48]) were significantly more at risk of complication than nephrectomies. An ASA score of 3 was also a significant risk factor of complications (OR 2.3, p = 0.014, 95% CI [1.17-4.47]) and an increased BMI carried a higher risk of conversion. There was no significant difference of conversion or complication rates between the first and last 500 patients. CONCLUSIONS: Upper urinary tract and adrenal surgeries can be performed by retroperitoneal laparoscopy. This surgical technic is safe and reproducible. The choice of the technic must be oriented by ASA, BMI and the type of surgery.

The Emerging Role and Promise of Biomarkers in Penile Cancer.

Penile cancer is a rare malignancy, which can be a source of devastating psychosexual distress because of its implication on sexual function and self-image. Current penile staging relies on invasive techniques and is often inaccurate. The authors review the promising biomarkers currently under investigation and their application to the staging and prognosis of penile cancer. Further development of such biomarkers provides the potential of improved clinical management of this disease.

The relationship between total testosterone levels and prostate cancer: a review of the continuing controversy.

PURPOSE: For many years it was believed that higher total testosterone contributed to prostate cancer and caused rapid cancer growth. International guidelines consider that adequate data are not available to determine whether there is additional risk of prostate cancer from testosterone replacement. Numerous studies with multiple designs and contradictory conclusions have investigated the relationship between total testosterone and prostate cancer development. To establish current knowledge in this field we reviewed the literature on total testosterone and the subsequent risk of prostate cancer as well as the safety of exogenous testosterone administration in patients with a history of prostate cancer. MATERIALS AND METHODS: We searched the literature to identify articles from 1994 to 2014 related to the relationship between total testosterone and prostate cancer. Emphasis was given to prospective studies, series with observational data and randomized, controlled trials. Case reports were excluded. Articles on testosterone replacement safety were selected by patient population (under active surveillance or with a prostate cancer history). We organized our results according to the relationship between total testosterone and prostate cancer, including 1) the possible link between low total testosterone and prostate cancer, 2) the effect of high levels and 3) the absence of any link. Finally, we summarized studies of the risk of exogenous testosterone administration in patients already diagnosed with prostate cancer, treated or on active surveillance. RESULTS: We selected 45 articles of the relationship between total testosterone and prostate cancer, of which 18 and 17 showed a relationship to low and high total testosterone, respectively, and 10 showed no relation. Total testosterone was defined according to the definition in each article. Contradictory findings have been reported, largely due to the disparate methodologies used in many studies. Most studies did not adhere to professional society guidelines on total testosterone measurements. One of 18 series of low total testosterone and prostate cancer adhered to published guidelines while none of 17 showing a relationship of high total testosterone to prostate cancer and only 1 of 10 that identified no relationship between total testosterone and prostate cancer adhered to measurements recommended in the guidelines. In 11 studies the risk of exogenous testosterone was examined in patients with a prostate cancer history. Many studies were limited by small cohort size and brief followup. However, overall this literature suggests that the risk of exogenous testosterone replacement in patients with prostate cancer appears to be small. CONCLUSIONS: The relationship between total testosterone and prostate cancer has been an area of interest among physicians for decades. Conflicting results have been reported on the relationship between total testosterone and subsequent prostate cancer. Much of this controversy appears to be based on conflicting study designs, definitions and methodologies. To date no prospective study with sufficient power has been published to unequivocally resolve the issue. The preponderance of studies of the safety of exogenous testosterone in men with a prostate cancer history suggests that there is little if any risk. However, because the risk has not proved to be zero, the most prudent course is to follow such men with regular prostate specific antigen measurements and digital rectal examinations.

Biomarkers in patients treated with BCG: an update.

INTRODUCTION: Bacillus Calmette-Guerin (BCG) instillations are the recommended treatment for non-muscle invasive bladder cancer but high recurrence and progression rates remain after treatment. Despite patients risk stratification, BCG effectiveness remains unpredictable. A close, invasive and expensive follow up is mandatory. To improve or even replace this heavy surveillance in this high risk population, validated biomarkers were developed. MATERIALS AND METHODS: To identify the useful tools for the urologist in monitoring bladder cancer patients, we reviewed the literature focusing on plasma and urinary biomarkers of BCG-therapy outcome. Articles dated from 1988 to 2013 including specific keywords (urinary bladder neoplasm, biological markers, intravesical administration, recurrence) were examined and relevant papers were selected. RESULTS: Before treatment initiation, genetic polymorphisms of multiple agents (cytokines, matrix-metalloproteinases) were found to become very useful to tailor therapy and monitoring. Those biomarkers belong to personalized medicine which is a topic of great interest today, but still need to be validated in cohorts from different ethnicities. During instillations, cytokines (IL-2, IL-8, IL-6/IL-10) were reported to be reliable to determine treatment response and efficacy. Further studies are needed to confirm results and standardize thresholds. After treatment, UroVysion, the FDA-approved fluorescence in situ hybridization (FISH), appeared to be the most robust marker of all the clinical parameters reviewed; but is not yet validated for BCG-treated patients. CONCLUSIONS: No recommendations for everyday practice can be established today, but a combination of several markers and clinicopathological characteristics may be the future. As bladder cancer diagnosis and management are evolving, practicing urologists should be aware of and utilize bladder cancer markers in clinical practice.

Chronic kidney disease and perioperative outcomes in urological oncological surgery.

OBJECTIVES: To evaluate baseline renal dysfunction among patients undergoing urological oncological surgery and its impact on early postoperative outcomes. METHODS: Between 2005 and 2011, patients who underwent minimally-invasive or open radical prostatectomy, partial nephrectomy and radical nephrectomy, or open radical cystectomy, respectively, were identified in the National Surgical Quality Improvement Program dataset. Preoperative kidney function was assessed using estimated glomerular filtration rate and staged according to National Kidney Foundation definitions. Multivariable logistic regression was used to model the association between preoperative renal function and the risk of 30-day mortality and major complications. Furthermore the impact of chronic kidney disease on operation time and length of hospital stay was assessed. RESULTS: Overall, 13,168 patients underwent radical prostatectomy (65.4%), partial nephrectomy (10.7%) and radical nephrectomy (16.1%) and radical cystectomy (7.8%), respectively; 50.1% of evaluable patients had reduced kidney function (chronic kidney disease II), and a further 12.6, 0.7 and 0.9% were respectively classified into chronic kidney disease stages III, IV, and V. Chronic kidney disease was an independent predictor of 30-day major postoperative complications (chronic kidney disease III: odds ratio 1.61, P < 0.001; chronic kidney disease IV: odds ratio 2.24, P = 0.01), of transfusions (chronic kidney disease III: odds ratio 2.14, P < 0001), of prolonged length of stay (chronic kidney disease III: odds ratio 2.61, P < 0.001; chronic kidney disease IV: odds ratio 3.37, P < 0.001; and chronic kidney disease V: odds ratio 1.68; P = 0.03) and of 30-day mortality (chronic kidney disease III: odds ratio 4.15, P = 0.01; chronic kidney disease IV: odds ratio 10.10, P = 0.003; and chronic kidney disease V: odds ratio 17.07, P < 0.001) compared with patients with no kidney disease. CONCLUSIONS: Renal dysfunction might be underrecognized in patients undergoing urological cancer surgery. Chronic kidney disease stages III, IV and V are independent predictors for poor 30-day postoperative outcomes.

Bladder recurrence after radical nephroureterectomy: predictors and impact on oncological outcomes.

OBJECTIVES: To identify predictive factors of bladder recurrence after radical nephroureterectomy and to evaluate the impact of this event on oncological outcomes. METHODS: We carried out a retrospective analysis of 237 patients treated with radical nephroureterectomy for urothelial carcinoma of the upper tract at our institution from 1998 to 2011. Univariable and multivariable models evaluated the prognostic factors of bladder recurrence, and its impact on recurrence-free survival and cancer-specific survival. RESULTS: The median age was 69.3 years (interquartile range 60-76). With a median follow up of 44 months (interquartile range 24-79), bladder recurrence occurred in 85 patients (35.9%). A previous history of bladder cancer (P = 0.01) and the presence of concomitant carcinoma in situ (P = 0.005) remained independent predictors of bladder recurrence. The presence of bladder recurrence was not correlated with worse oncological outcomes in terms of disease recurrence (P = 0.075) and cancer-specific mortality (P = 0.06). However, the patients who experienced muscle-invasive bladder cancer recurrence had worse outcomes in terms of cancer-specific mortality (P = 0.01). Standard pathological features of aggressiveness, such as higher tumor stage (P = 0.05), higher grade (P = 0.01) and carcinoma in situ (P = 0.03), were independent predictors of muscle-invasive bladder cancer recurrence. CONCLUSIONS: Previous history of bladder cancer, tumor location and concomitant carcinoma in situ are independent predictors of bladder recurrence in patients undergoing radical nephroureterectomy. Bladder recurrence overall does not impact the oncological outcomes, but a muscle-invasive bladder recurrence is associated with a worse cancer-specific mortality. Standard pathological features of urothelial carcinoma of the upper tract aggressiveness (pT-stage, grade) are independent predictors of muscle-invasive bladder cancer recurrence.