Oncological outcomes after attempted nerve-sparing radical prostatectomy (NSRP) in patients with high-risk prostate cancer are comparable to standard non-NSRP: a longitudinal long-term propensity-matched single-centre study.

OBJECTIVE: To assess the long-term safety of nerve-sparing radical prostatectomy (NSRP) in men with high-risk prostate cancer (PCa) by comparing survival outcomes, disease recurrence, the need for additional therapy, and perioperative outcomes of patients undergoing NSRP to those having non-NSRP. PATIENTS AND METHODS: We included consecutive patients at a single, academic centre who underwent open RP for high-risk PCa, defined as preoperative prostate-specific antigen level of > 20 ng/mL and/or postoperative International Society of Urological Pathology Grade Group 4 or 5 (i.e., Gleason score ≥ 8) and/or ≥pT3 and/or pN1 assessing the RP and lymph node specimen. We calculated a propensity score and used inverse probability of treatment weighting to match baseline characteristics of patients with high-risk PCa who underwent NSRP vs non-NSRP. We analysed oncological outcome as time-to-event and calculated hazard ratios (HRs). RESULTS: A total of 726 patients were included in this analysis of which 84% (n = 609) underwent NSRP. There was no evidence for the positive surgical margin rate being different between the NSRP and non-NSRP groups (47% vs 49%, P = 0.64). Likewise, there was no evidence for the need for postoperative radiotherapy being different in men who underwent NSRP from those who underwent non-NSRP (HR 0.78, 95% confidence interval [CI] 0.53-1.15). NSRP did not impact the risk of any recurrence (HR 0.99, 95% CI 0.73-1.34, P = 0.09) and there was no evidence for survival being different in men who underwent NSRP to those who underwent non-NSRP (HR 0.65, 95% CI 0.39-1.08). There was also no evidence for the cancer-specific survival (HR 0.56, 95% CI 0.29-1.11) or progression-free survival (HR 0.99, 95% CI 0.73-1.34) being different between the groups. CONCLUSION: In patients with high-risk PCa, NSRP can be attempted without compromising long-term oncological outcomes provided a comprehensive assessment of objective (e.g., T Stage) and subjective (e.g., intraoperative appraisal of tissue planes) criteria are conducted.

Safety and quality of cystectomy and pelvic lymph node dissection after neoadjuvant durvalumab and cisplatin/gemcitabine.

OBJECTIVE: To report on the surgical safety and quality of pelvic lymph node dissection (PLND) in patients treated with radical cystectomy (RC) and PLND for muscle-invasive bladder cancer (MIBC) after neoadjuvant chemo-immunotherapy. PATIENTS AND METHODS: The Swiss Group for Clinical Cancer Research (SAKK) 06/17 was an open-label single-arm phase II trial including 61 cisplatin-fit patients with clinical stage (c)T2-T4a cN0-1 operable urothelial MIBC or upper urinary tract cancer. Patients received neoadjuvant cisplatin/gemcitabine and durvalumab followed by surgery. Prospective quality assessment of surgeries was performed via central review of intraoperative photographs. Postoperative complications were assessed using the Clavien-Dindo Classification. Data were analysed descriptively. RESULTS: A total of 50 patients received RC and PLND. All patients received neoadjuvant chemo-immunotherapy. The median (interquartile range) number of lymph nodes removed was 29 (23-38). No intraoperative complications were registered. Grade ≥III postoperative complications were reported in 12 patients (24%). Complete nodal dissection (100%) was performed at the level of the obturator fossa (bilaterally) and of the left external iliac region; in 49 patients (98%) at the internal iliac region and at the right external iliac region; in 39 (78%) and 38 (76%) patients at the right and left presacral level, respectively. CONCLUSION: This study supports the surgical safety of RC and PLND following neoadjuvant chemo-immunotherapy in patients with MIBC. The extent and completeness of protocol-defined PLND varies between patients, highlighting the need to communicate and monitor the surgical template.

Impact of the extent of lymph node dissection on survival outcomes in clinically lymph node-positive bladder cancer.

OBJECTIVE: To determine the oncological impact of extended pelvic lymph node dissection (ePLND) vs standard PLND (sPLND) during radical cystectomy (RC) in clinically lymph node-positive (cN+) bladder cancer (BCa). PATIENTS AND METHODS: In this retrospective, multicentre study we included 969 patients who underwent RC with sPLND (internal/external iliac and obturator lymph nodes) or ePLND (sPLND plus common iliac and presacral nodes) with or without platin-based peri-operative chemotherapy for cTany N1-3 M0 BCa between 1991 and 2022. We assessed the impact of ePLND on recurrence-free survival (RFS) and the distribution of recurrences (locoregional and distant recurrences). The secondary endpoint was overall survival (OS). We performed propensity-score matching using covariates associated with the extent of PLND in univariable logistic regression analysis. The association of the extent of PLND with RFS and OS was investigated using Cox regression models. RESULTS: Of 969 cN+ patients, 510 were 1:1 matched on propensity scores. The median (interquartile range [IQR]) time to recurrence was 8 (4-16) months, and median (IQR) follow-up of alive patients was 30 (13-51) months. Disease recurrence was observed in 104 patients in the ePLND and 107 in the sPLND group. Of these, 136 (27%), 47 (9.2%) and 19 patients (3.7%) experienced distant, locoregional, or both distant and locoregional disease recurrence, respectively. When stratified by the extent of PLND, we did not find a difference in recurrence patterns (P > 0.05). ePLND improved neither RFS (hazard ratio [HR] 0.91, 95% confidence interval [CI] 0.70-1.19; P = 0.5) nor OS (HR 0.78, 95% CI 0.60-1.01; P = 0.06) compared to sPLND. Stratification by induction chemotherapy did not change outcomes. CONCLUSION: Performing an ePLND at the time of RC in cN+ patients improved neither RFS nor OS compared to sPLND, regardless of induction chemotherapy status. Pretreatment risk stratification is paramount to identify ideal candidates for RC with ePLND as part of a multimodal treatment approach.

The optimal number of induction chemotherapy cycles in clinically lymph node-positive bladder cancer.

OBJECTIVE: To investigate the optimal number of induction chemotherapy cycles needed to achieve a pathological response in patients with clinically lymph node-positive (cN+) bladder cancer (BCa) who received three or four cycles of induction chemotherapy followed by consolidative radical cystectomy (RC) with pelvic lymph node dissection. PATIENTS AND METHODS: We included 388 patients who received three or four cycles of cisplatin/gemcitabine or (dose-dense) methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC), followed by consolidative RC for cTanyN1-3M0 BCa. We compared pathological complete (pCR = ypT0N0) and objective response (pOR = yp ≤T1N0) between treatment groups. Predictors of pCR and/or pOR were assessed using uni- and multivariable logistic regression analysis. The secondary endpoints were overall (OS) and cancer-specific survival (CSS). We evaluated the association between the number of induction chemotherapy cycles administered and survival outcomes on multivariable Cox regression. RESULTS: Overall, 101 and 287 patients received three or four cycles of induction chemotherapy, respectively. Of these, 72 (19%) and 128 (33%) achieved pCR and pOR response, respectively. The pCR (20%, 18%) and pOR (40%, 31%) rates did not differ significantly between patients receiving three or four cycles (P > 0.05). The number of cycles was not associated with pCR or pOR on multivariable logistic regression analyses. The 2-year OS estimates were 63% (95% confidence interval [CI] 0.53-0.74) and 63% (95% CI 0.58-0.7) for patients receiving three or four cycles, respectively. Receiving three vs four cycles was not associated with OS and CSS on uni- or multivariable Cox regression analyses. CONCLUSION: Pathological response and survival outcomes did not differ between administering three or four induction chemotherapy cycles in patients with cN+ BCa. A fewer cycles (minimum three) may be oncologically sufficient in patients with cN+ BCa, while decreasing the wait for definitive local therapy in those patients who end up without a response to chemotherapy. This warrants further validation.

A longitudinal study evaluating interim assessment of neoadjuvant chemotherapy for bladder cancer.

OBJECTIVES: To evaluate the usefulness of radiological re-staging after two and four cycles of neoadjuvant chemotherapy (NAC), the impact of re-staging on further patient management, and the correlation between clinical and final pathological tumour stage at radical cystectomy (RC). PATIENTS AND METHODS: We conducted a longitudinal, single-centre, cohort study of prospectively collected consecutive patients who underwent NAC and RC for urothelial muscle-invasive bladder cancer between July 2001 and December 2017. Patients underwent repeated computed tomography scans for re-staging after two cycles of NAC and after completion of NAC before RC. RESULTS: Of 180 patients, 110 had ≥four cycles of NAC and had complete imaging available. In the entire cohort, further patient management was only changed in 2/180 patients (1.1%) after two cycles of NAC based on radiological findings. Patients who were stable after two cycles but then downstaged after at least four cycles of NAC had a similarly lowered risk of death (hazard ratio [HR] 0.53). Only one patient downstaged after two cycles was subsequently upstaged after four cycles. Clinical downstaging was observed in 51 patients (46%), 55 patients (50%) had no change in clinical stage and four patients (3.6%) were clinically upstaged. Patients clinically downstaged after four cycles of NAC had a lower risk of death (HR 0.49, 95% confidence interval 0.25-0.94; P = 0.033) compared to those with no change or upstaged after completion of NAC. CONCLUSIONS: Re-staging of muscle-invasive bladder cancer after two cycles of NAC offers little additional information, rarely changes patient management, and may therefore be omitted, whereas re-staging after completion of NAC by CT is a strong predictor of overall survival.

Seminal Vesical Sparing Cystectomy for Bladder Cancer is Feasible with Good Functional Results without Impairing Oncological Outcomes: A Longitudinal Long-Term Propensity-Matched Single Center Study.

PURPOSE: Seminal vesicle-sparing radical cystectomy has been reported to improve short-term functional results without compromising oncological outcomes. However, there is still a lack of data on long-term outcomes after seminal vesicle-sparing radical cystectomy. The aim of this study was to compare oncological and functional outcomes in patients after seminal vesicle-sparing vs nonseminal vesicle-sparing radical cystectomy. MATERIALS AND METHODS: Oncological and functional outcomes of 470 consecutive patients after radical cystectomy and orthotopic ileal reservoir from 2000 to 2017 were evaluated. They were stratified into 6 groups according to nerve-sparing and seminal vesicle-sparing status as attempted during surgery: no sparing at all (55), unilateral nerve sparing (159), bilateral nerve sparing (132), unilateral seminal vesicle-sparing and unilateral nerve sparing (30), unilateral seminal vesicle sparing and bilateral nerve sparing (45), and bilateral seminal vesicle sparing (49) and used propensity modeling to adjust for preoperative differences. RESULTS: Median followup among the entire cohort was 64 months. Among the 6 groups, our analysis showed no difference in local recurrence-free survival (p=0.173). However, progression-free, cancer-specific and overall survival were more favorable in patients with seminal vesicle-sparing radical cystectomy (p <0.001, p=0.006 and p <0.001, respectively). Proportions of patients with erectile function recovery were higher in the seminal vesicle-sparing groups at all time points in all analyses, respectively, with pronounced earlier recovery in patients with bilateral seminal vesicle sparing. Importantly, patients with seminal vesicle sparing were significantly less in need of erectile aids to achieve erection and intercourse. Over the whole period, daytime urinary-continence was significantly better in the seminal vesicle sparing groups (OR 2.64 to 5.21). CONCLUSIONS: In a highly selected group of patients, seminal vesicle sparing radical cystectomy is oncologically safe and results in excellent functional outcomes that are reached at an earlier time point after surgery and remain superior over a longer period of time.

A treatment strategy to help select patients who may not need secondary intervention to remove symptomatic ureteral stones after previous stenting.

PURPOSE: This study aimed at evaluating whether removal of the ureteral stent the day before scheduled secondary intervention facilitates spontaneous ureteral stone passage and thus can spare the pre-stented patient this surgery. METHODS: Retrospective analysis of a single-centre consecutive series of 216 patients after previous stenting due to a symptomatic ureteral stone from 01/2013 to 01/2018. Indwelling stents were removed under local anaesthesia. Patients were told to filter their urine overnight. Multivariate analysis was performed to assess predictive factors for spontaneous stone passage. RESULTS: 34% (74/216) of patients had spontaneous stone passage while the stent was indwelling. Of the remaining 142 patients, 41% (58/142) had spontaneous stone passage within 24 h after stent removal. Only 84/216 (39%) patients needed secondary intervention. Multivariate logistic regression analysis of all 216 patients showed a significant association between spontaneous stone passage and smaller stone size (p < 0.001), distal stone location (p = 0.046) and stent dwell time (p = 0.02). Predictive factors for spontaneous stone passage after stent removal were smaller size (p < 0.001), distal location (p = 0.001), and stone movement while the stent was indwelling (p = 0.016). A treatment strategy was established that helps select patients suitable for conservative management. CONCLUSIONS: The majority (61%) of ureteral stones passed spontaneously after pre-stenting; 34% while the stent was indwelling, 27% within 24 h after stent removal. Besides distal stone location, stone size (< 6 mm) and stone movement (≥ 5 cm) while the stent is indwelling indicate patients who are likely to pass their ureteral stone spontaneously after stent removal. The treatment strategy (decision tree) presented here helps identify those patients. TRIAL REGISTRATION: https://doi.org/10.1186/ISRCTN12112914 .

Positive Pre-cystectomy Biopsies of the Prostatic Urethra or Bladder Neck Do Not Necessarily Preclude Orthotopic Bladder Substitution.

PURPOSE: We investigated the influence of positive pre-cystectomy biopsies of the prostatic urethra in males and the bladder neck in females on urethral recurrence, cancer specific and overall survival, and functional outcomes after orthotopic bladder substitution. MATERIALS AND METHODS: We retrospectively analyzed the records of 803 consecutive patients, including 703 males and 100 females, who underwent orthotopic bladder substitution as well as pre-cystectomy biopsy of the prostatic urethra in males and the bladder neck in females, at our institution between April 1986 and December 2017. RESULTS: Pre-cystectomy biopsies were negative in 755 of the 803 patients (94%) (group 1) and positive in 48 (6%) (group 2). Biopsies in group 2 revealed carcinoma in situ in 35 of the 48 cases (73%), pTaG1/G2 in 5 (10%) and pTaG3/pT1G3 in 8 (17%). Median followup was 64 months (IQR 21-128). At a median followup of 56 months (IQR 18-127) urethral recurrence developed in 45 of the 803 patients (5.6%), including 30 of the 755 (4%) in group 1 and 15 of the 48 (31.3%) in group 2 (p <0.001). Only 10 of the 45 patients (22%) with urethral recurrence required salvage urethrectomy while locally conservative treatment was successful in 27 (60%). Of the remaining 8 patients 6 of 45 (13%) underwent synchronous palliative chemotherapy and 2 of 45 (4%) refused treatment. Multivariate regression analysis revealed a higher risk of urethral recurrence if patients had positive pre-cystectomy biopsies (group 2 HR 6.49, 95% CI 3.33-12.62, p <0.001) or received neoadjuvant or adjuvant chemotherapy (HR 3.05, 95% CI 1.66-5.59, p <0.001). Cancer specific and overall survival as well as functional outcomes were similar in the 2 groups. CONCLUSIONS: Positive pre-cystectomy biopsies prior to orthotopic bladder substitution increased the urethral recurrence rate but did not lower cancer specific or overall survival. Most urethral recurrences were managed successfully by local treatment. Orthotopic bladder substitution is an option in highly selected patients with positive, noninvasive pre-cystectomy biopsies, provided that they undergo regular followup including urethral cytology.

Optical and Cross-Sectional Imaging Technologies for Bladder Cancer.

Optical and cross-sectional imaging plays critical roles in bladder cancer diagnostics. White light cystoscopy remains the cornerstone for the management of non-muscle-invasive bladder cancer. In the last decade, significant technological improvements have been introduced for optical imaging to address the known shortcomings of white light cystoscopy. Enhanced cystoscopy modalities such as blue light cystoscopy and narrowband imaging survey a large area of the urothelium and provide contrast enhancement to detect additional lesions and decrease cancer recurrence. However, higher false-positive rates accompany the gain of sensitivity. Optical biopsy technologies, including confocal laser endomicroscopy and optical coherence tomography, provide cellular resolutions combined with subsurface imaging, thereby enabling optical-based cancer characterization, and may lead to real-time cancer grading and staging. Coupling of fluorescently labeled binding agents with optical imaging devices may translate into high molecular specificity, thus enabling visualization and characterization of biological processes at the molecular level. For cross-sectional imaging, upper urinary tract evaluation and assessment potential extravesical tumor extension and metastases are currently the primary roles, particularly for management of muscle-invasive bladder cancer. Multi-parametric MRI, including dynamic gadolinium-enhanced and diffusion-weighted sequences, has been investigated for primary bladder tumor detection. Ultrasmall superparamagnetic particles of iron oxide (USPIO) are a new class of contrast agents that increased the accuracy of lymph node imaging. Combination of multi-parametric MRI with positron emission tomography is on the horizon to improve accuracy rates for primary tumor diagnostics as well as lymph node evaluation. As these high-resolution optical and cross-sectional technologies emerge and develop, judicious assessment and validation await for their clinical integration toward improving the overall management of bladder cancer.

Stenting Prior to Cystectomy is an Independent Risk Factor for Upper Urinary Tract Recurrence.

PURPOSE: Patients with bladder cancer who present with hydronephrosis may require drainage of the affected kidney before receiving further cancer treatment. Drainage can be done by retrograde stenting or percutaneously. However, retrograde stenting carries the risk of tumor cell spillage to the upper urinary tract. The aim of this study was to evaluate whether patients with bladder cancer are at higher risk for upper urinary tract recurrence if retrograde stenting has been performed prior to radical cystectomy. MATERIALS AND METHODS: We retrospectively analyzed the records of 1,005 consecutive patients with bladder cancer who underwent radical cystectomy at our department between January 2000 and June 2016. Negative intraoperative ureteral margins were mandatory for study inclusion. Patients received regular followup according to our institutional protocol, including imaging of the upper urinary tract and urine cytology. RESULTS: Preoperative drainage of the upper urinary tract was performed in 114 of the 1,005 patients (11%), including in 53 (46%) by Double-J® stenting and in 61 (54%) by percutaneous nephrostomy. Recurrence developed in the upper urinary tract in 31 patients (3%) at a median of 17 months after cystectomy, including 7 of 53 (13%) in the Double-J group, 0% in the nephrostomy group and 24 of 891 (3%) in the no drainage group. Multivariate regression analysis revealed a higher risk of upper urinary tract recurrence if patients underwent Double-J stenting (HR 4.54, 95% CI 1.43-14.38, p = 0.01) and preoperative intravesical instillations (HR 2.94, 95% CI 1.40-6.16, p = 0.004). CONCLUSIONS: Patients who undergo Double-J stenting prior to radical cystectomy are at higher risk for upper urinary tract recurrence. If preoperative upper urinary tract drainage is required, percutaneous drainage might be recommended.

Patients with an Orthotopic Low Pressure Bladder Substitute Enjoy Long-Term Good Function.

PURPOSE: Orthotopic bladder substitution has been performed on a regular basis for more than 30 years and yet data on long-term functional outcomes are still lacking. MATERIALS AND METHODS: We evaluated 181 men and 19 women who underwent radical cystectomy and urinary diversion with ileal orthotopic bladder substitution from 1985 to 2004 and who had 10 years or more of followup. RESULTS: Median age at radical cystectomy was 63 years (IQR 57-69). Median followup was 167 months (IQR 137-206). Daytime and nighttime continence rates peaked 24 months postoperatively and decreased slightly thereafter during almost 2 decades. At 10, 15 and 20 years daytime continence rates were 92%, 90% and 79%, and nighttime continence rates were 70%, 65% and 55%, respectively. During the day and at night fewer than 3% and 10% of patients, respectively, had urine loss 100 ml or greater at any time 10 years or longer after surgery. At 10 and 20 years 11 of 200 patients (6%) and 1 of 29 (3%), respectively, had to perform clean intermittent self-catheterization. After an initial postoperative decrease in the estimated glomerular filtration rate the subsequent decrease was less than 1 ml/minute/1.73 m(2) per year. A total of 81 complications were observed in 42 of the 200 patients (21%) 10 years or longer after radical cystectomy with pyelonephritis as the most frequent cause. CONCLUSIONS: Patients who survive up to 20 years after radical cystectomy and diversion with an ileal orthotopic bladder substitution may enjoy satisfactory urinary continence and retain the ability to void spontaneously while experiencing no more than a physiological decrease in renal function.

Long-term results of a prospective randomized trial assessing the impact of re-adaptation of the dorsolateral peritoneal layer after extended pelvic lymph node dissection and cystectomy.

OBJECTIVE: To evaluate the long-term oncological and functional outcomes of re-adaptation of the dorsolateral peritoneal layer after pelvic lymph node dissection (PLND) and cystectomy. PATIENTS AND METHODS: A randomized, single-centre, single-blinded, two-arm trial was conducted on 200 consecutive patients who underwent PLND and cystectomy for bladder cancer (

Open radical cystectomy: still the gold standard for muscle invasive bladder cancer.

INTRODUCTION: Muscle invasive bladder cancer is an unforgiving disease, and if untreated, it leads to death within 2 years of the diagnosis in >85 % of the patients. Long-term oncologic efficacy remains the ultimate standard that all procedures have to be measured by. In the past decades, open radical cystectomy (RC), extended pelvic lymph node dissection (PLND), and urinary diversion have been established as the gold standard. In the last few years, however, growing attention has been set on robotic-assisted radical cystectomy (RARC). RESULTS: Even in the very long term, open RC has good oncological results and if an ileal neobladder is performed excellent functional results. Follow-up of patients after open RC exceeds more than a decade which is unsurpassed by any other technique. Its outcomes have been proven to be durable and cost-effective. Least perioperative complications as well as best oncological and functional results can be achieved if open RC and urinary diversion were performed in a high-volume hospital by high-volume surgeons and an experienced team. CONCLUSIONS: Despite upcoming new technologies such as RARC, open RC following extended (PLND) remains the gold standard treatment for high-grade muscle invasive bladder cancer.

Oncological and functional outcomes of postoperative total parenteral nutrition after radical cystectomy in bladder cancer patients: A single-center randomized trial.

OBJECTIVES: To prospectively evaluate the long-term oncological and functional outcomes of postoperative total parenteral nutrition after radical cystectomy. METHODS: A total of 157 consecutive patients (≤cT3, cN0, cM0) who underwent extended pelvic lymph node dissection, radical cystectomy and ileal urinary diversion from September 2008 to March 2011 at a single center were randomized to receive either postoperative total parenteral nutrition (group A; n = 74) or oral nutrition alone (group B; n = 83). All but two patients in group B (who were thus excluded from further analysis) had regular postoperative follow up at the Department of Urology, University of Bern, Switzerland. Computed tomography and bone scan were carried out to assess local recurrences and distal metastases. We used validated questionnaires to evaluate bowel function, sexual function and quality of life, and an institutional questionnaire to evaluate neobladder function. RESULTS: The median follow up was 50 months (IQR 21-62). The rate of local recurrences (4/74 [5.4%] in group A; 4/81 [4.9%] in group B; P = 0.9) and the rate of distant metastases (23/74 [31%] in group A; 23/81 [28%] in group B; P = 0.72) did not differ between the two groups. There was no difference in cancer-specific (P = 0.86) and overall survival (P = 0.85). Group B patients had significantly better bowel function at 3 months (P = 0.03) and 12 months (P = 0.01). There was no difference in terms of quality of life, and sexual and neobladder function. CONCLUSIONS: The administration of total parenteral nutrition after radical cystectomy does not impair long-term oncological outcomes. It does, however, negatively influence long-term bowel function.

Optimization of Extracorporeal Shock Wave Lithotripsy Delivery Rates Achieves Excellent Outcomes for Ureteral Stones: Results of a Prospective Randomized Trial.

PURPOSE: Management of ureteral stones remains controversial. To determine whether optimizing the extracorporeal shock wave lithotripsy delivery rate would improve the treatment of solitary ureteral stones we compared the outcomes of 2 delivery rates in a prospective randomized trial. MATERIALS AND METHODS: From July 2010 to October 2012, 254 consecutive patients were randomized to extracorporeal shock wave lithotripsy at a shock wave delivery rate of 60 and 90 pulses per minute in 130 and 124, respectively. The primary study end point was the stone-free rate at 3-month followup. Secondary end points were stone disintegration, treatment time, complications and the rate of secondary treatments. Descriptive statistics were used to compare end points between the 2 groups. The adjusted OR and 95% CI were calculated to assess predictors of success. RESULTS: The stone-free rate at 3 months was significantly higher in patients who underwent extracorporeal shock wave lithotripsy at a shock wave delivery rate of 90 pulses per minute than in those who received 60 pulses per minute (91% vs 80%, p = 0.01). Patients with proximal (100% vs 83%, p = 0.005) and mid ureteral stones (96% vs 73%, p = 0.03) accounted for the observed difference but not those with distal ureteral stones (81% vs 80%, p = 0.9, respectively). Treatment time, complications and the rate of secondary treatments were comparable between the 2 groups. On multivariable analysis the shock wave delivery rate of 90 pulses per minute, proximal stone location, stone density, stone size and an absent indwelling Double-J® stent were independent predictors of success. CONCLUSIONS: Optimizing the extracorporeal shock wave lithotripsy delivery rate can achieve excellent results for ureteral stones.

Is thermochemotherapy with the Synergo system a viable treatment option in patients with recurrent non-muscle-invasive bladder cancer?

OBJECTIVES: To prospectively evaluate the outcome of combined microwave-induced bladder wall hyperthermia and intravesical mitomycin C instillation (thermochemotherapy) in patients with recurrent non-muscle-invasive bladder cancer. METHODS: Between 2003 and 2009, 21 patients (median age 70 years, range 35-95 years) with recurrent non-muscle-invasive bladder cancer (pTaG1-2 n = 9; pTaG3 n = 3; pT1 n = 9; concurrent pTis n = 8) were prospectively enrolled. Of 21 patients, 15 (71%) had received previous intravesical instillations with bacillus Calmette-Guérin, mitomycin C and/or farmorubicin. Thermochemotherapy using the Synergo system was carried out in 11 of 21 patients (52%) with curative intent, and in 10 of 21 patients (48%) as prophylaxis against recurrence. RESULTS: The median number of thermochemotherapy cycles per patient was six (range 1-12). Adverse effects were frequent and severe: urinary urgency/frequency in 11 of 21 patients (52%), pain in eight of 21 patients (38%) and gross hematuria in five of 21 patients (24%). In eight of 21 patients (38%), thermochemotherapy had to be abandoned because of the severity of the adverse effects (pain in 3/8, severe bladder spasms in 2/8, allergic reaction in 2/8, urethral perforation in 1/8). Overall, six of 21 patients (29%) remained free of tumor after a median follow up of 50 months (range 1-120), six of 21 patients (29%) had to undergo cystectomy because of multifocal recurrences or cancer progression and seven of 21 patients (33%) died (2/7 of metastatic disease, 5/7 of non-cancer related causes). CONCLUSIONS: Given the high rate of severe side-effects leading to treatment discontinuation, as well as the limited tumor response, thermochemotherapy should be offered only in highly selected cases of recurrent non-muscle-invasive bladder cancer.

Protocol for a randomized, placebo-controlled, double-blind clinical trial investigating sacral neuromodulation for neurogenic lower urinary tract dysfunction.

BACKGROUND: Sacral neuromodulation has become a well-established and widely accepted treatment for refractory non-neurogenic lower urinary tract dysfunction, but its value in patients with a neurological cause is unclear. Although there is evidence indicating that sacral neuromodulation may be effective and safe for treating neurogenic lower urinary tract dysfunction, the number of investigated patients is low and there is a lack of randomized controlled trials. METHODS AND DESIGN: This study is a prospective, randomized, placebo-controlled, double-blind multicenter trial including 4 sacral neuromodulation referral centers in Switzerland. Patients with refractory neurogenic lower urinary tract dysfunction are enrolled. After minimally invasive bilateral tined lead placement into the sacral foramina S3 and/or S4, patients undergo prolonged sacral neuromodulation testing for 3-6 weeks. In case of successful (defined as improvement of at least 50% in key bladder diary variables (i.e. number of voids and/or number of leakages, post void residual) compared to baseline values) prolonged sacral neuromodulation testing, the neuromodulator is implanted in the upper buttock. After a 2 months post-implantation phase when the neuromodulator is turned ON to optimize the effectiveness of neuromodulation using sub-sensory threshold stimulation, the patients are randomized in a 1:1 allocation in sacral neuromodulation ON or OFF. At the end of the 2 months double-blind sacral neuromodulation phase, the patients have a neuro-urological re-evaluation, unblinding takes place, and the neuromodulator is turned ON in all patients. The primary outcome measure is success of sacral neuromodulation, secondary outcome measures are adverse events, urodynamic parameters, questionnaires, and costs of sacral neuromodulation. DISCUSSION: It is of utmost importance to know whether the minimally invasive and completely reversible sacral neuromodulation would be a valuable treatment option for patients with refractory neurogenic lower urinary tract dysfunction. If this type of treatment is effective in the neurological population, it would revolutionize the management of neurogenic lower urinary tract dysfunction. TRIAL REGISTRATION NUMBER: http://www.clinicaltrials.gov; Identifier: NCT02165774.

Prospective evaluation of sexual health following radical cystectomy due to bladder cancer.

Background: There is a lack of data concerning sexual health following open radical cystectomy (RC), especially in elderly patients and women. Aim: To describe sexual health and its impact on general health as well as survival in patients undergoing standard open RC for the treatment of bladder cancer (BC). Due to limited data, subgroup analysis for elderly patients and women was performed. Methods: A prospective noninterventional clinical study was performed evaluating sexual health in RC with any kind of urinary diversion due to BC with a follow-up of 12 months after RC. The study was approved by the local ethics review board (A 2021-0175) and was registered at the German Clinical Trial Register (DRKS00026255). Assessment of sexual health was done with the following validated questionnaires: EORTC QLQ-C30 (for quality of life; European Organisation for Research and Treatment of Cancer), EORTC SH22 (for sexual health), and IIEF-5 (5-item International Index of Erectile Function). Outcomes: The standard measurements of EORTC QLQ-C30, EORTC SH22, and IIEF-5 as well as overall survival. Results: Thirty-two patients participated in the study with a mean age of 71.5 years (SD, 9.7): 25 (78.1%) were male and 7 (21.9%) were female. Overall there is a heterogenic picture for sexual health in the study population, but sexual satisfaction is significantly higher prior to surgery while the importance of a sex life stays high and stable. Interestingly, the general health score is significantly correlated to sexual satisfaction (Pearson's correlation; r = 0.522, P = .002) preoperatively but not following surgery: r = 0.103 (P = .665) after 3 months, r = 0.478 (P = .052) after 6 months, r = 0.276 (P = .302) after 9 months, and r = 0.337 (P = .202) after 12 months. The importance of a sex life is still essential for the patients, especially when recovering from RC; nearly the same can be reported for elderly patients. Unfortunately, the data for women are too limited to report robust results. Clinical Implications: Evaluation, advice, and monitoring of sexual health must be integrated into clinical practice, particularly in women. Strengths and Limitations: At least to our knowledge, this is the first systematic prospective evaluation of sexual health in patients with BC receiving RC. Due to the small sample size, there is a risk of selection bias. Conclusion: Sexual health is important for patients with BC receiving RC, and it is an essential part of quality of life, especially in elderly patients.

Hyperthermic Intravesical Chemotherapy (HIVEC) Using Epirubicin in an Optimized Setting in Patients with NMIBC Recurrence after Failed BCG Therapy.

To evaluate hyperthermic intravesical chemotherapy (HIVEC) using conductive heating and epirubicin in an optimized setting as an alternative to radical cystectomy in patients with recurrent non-muscle invasive bladder cancer (NMIBC) who have failed bacillus Calmette-Guérin (BCG) therapy. We retrospectively analyzed our prospectively recorded database of patients who underwent HIVEC between 11/2017 and 11/2022 at two Swiss University Centers. Cox regression analysis was used for univariate/multivariate analysis, and the Kaplan-Meier method for survival analysis. Of the 39 patients with NMIBC recurrence after failed BCG therapy, 25 (64%) did not recur within the bladder after a median follow-up of 28 months. The 12- and 24-month intravesical RFS were 94.8% and 80%, respectively. Extravesical recurrence developed in 14/39 (36%) of patients. Only 7/39 (18%) patients had to undergo radical cystectomy. Seven patients (18%) progressed to metastatic disease, with five of these (71%) having previously developed extravesical disease. No adverse events > grade 2 occurred during HIVEC. Device-assisted HIVEC using epirubicin in an optimized setting achieved excellent RFS rates in this recurrent NMIBC population at highest risk for recurrence after previously failed intravesical BCG therapy. Extravesical disease during or after HIVEC, however, was frequent and associated with metastatic disease and consecutively poor outcomes.