Follow-up strategies after trimodal treatment for muscle-invasive bladder cancer: a systematic review.

PURPOSE: Optimal follow-up strategies following trimodal treatment for muscle invasive bladder cancer play a crucial role in detecting and managing relapse and side-effects. This article provides a comprehensive summary of the patterns and risk factors of relapse, functional outcomes, and follow-up protocols. METHODS: A systematic literature search on PubMed and review of current guidelines and institutional follow-up protocols after trimodal therapy were conducted. RESULTS: Out of 200 identified publications, 43 studies (28 retrospective, 15 prospective) were selected, encompassing 7447 patients (study sizes from 24 to 728 patients). Recurrence rates in the urinary bladder varied between 14-52%; 3-16% were muscle-invasive while 11-36% were non-muscle invasive. Nodal recurrence occurred at 13-16% and distant metastases at 15-35%. After 5 and 10 years of follow-up, around 60-85% and 45-75% of patients could preserve their bladder, respectively. Various prognostic risk factors associated with relapse and inferior survival were proposed, including higher disease stage (> c/pT2), presence of extensive/multifocal carcinoma in situ (CIS), hydronephrosis, multifocality, histological subtypes, incomplete transurethral resection of bladder tumor (TURBT) and incomplete response to radio-chemotherapy. The analyzed follow-up guidelines varied slightly in terms of the number, timing, and types of investigations, but overall, the recommendations were similar. CONCLUSION: Randomized prospective studies should focus on evaluating the impact of specific follow-up protocols on oncological and functional outcomes following trimodal treatment for muscle-invasive bladder cancer. It is crucial to evaluate personalized adaption of follow-up protocols based on established risk factors, as there is potential for improved patient outcomes and resource allocation.

bTUNED: transcutaneous tibial nerve stimulation for neurogenic lower urinary tract dysfunction.

OBJECTIVE: To present the protocol for a randomized controlled trial (RCT) evaluating the efficacy and safety of transcutaneous tibial nerve stimulation (TTNS) for refractory neurogenic lower urinary tract dysfunction (NLUTD). STUDY DESIGN AND RESULTS: bTUNED (bladder and TranscUtaneous tibial Nerve stimulation for nEurogenic lower urinary tract Dysfunction) is an international multicentre, sham-controlled, double-blind RCT investigating the efficacy and safety of TTNS. The primary outcome is success of TTNS, defined as improvements in key bladder diary variables at study end compared to baseline values. The focus of the treatment is defined by the Self-Assessment Goal Achievement (SAGA) questionnaire. Secondary outcomes are the effect of TTNS on urodynamic, neurophysiological, and bowel function outcome measures, as well as the safety of TTNS. CONCLUSIONS: A total of 240 patients with refractory NLUTD will be included and randomized 1:1 into the verum or sham TTNS group from March 2020 until August 2026. TTNS will be performed twice a week for 30 min during 6 weeks. The patients will attend baseline assessments, 12 treatment visits and follow-up assessments at the study end.

Management of chronic primary pelvic pain syndromes.

Management of chronic pelvic pain (CPP) remains a huge challenge for care providers and a major burden for healthcare systems. Treating chronic pain that has no obvious cause warrants an understanding of the difficulties in managing these conditions. Chronic pain has recently been accepted as a disease in its own right by the World Health Organization, with chronic pain without obvious cause being classified as chronic primary pain. Despite innumerable treatments that have been proposed and tried to date for CPP, unimodal therapeutic options are mostly unsuccessful, especially in unselected individuals. In contrast, individualised multimodal management of CPP seems the most promising approach and may lead to an acceptable situation for a large proportion of patients. In the present review, the interdisciplinary and interprofessional European Association of Urology Chronic Pelvic Pain Guideline Group gives a contemporary overview of the most important concepts to successfully diagnose and treat this challenging disease.

Reduction of stent-associated morbidity by minimizing stent material: a prospective, randomized, single-blind superiority trial assessing a customized 'suture stent'.

OBJECTIVES: To compare a customized 'suture stent' with a standard ureteric stent regarding stent-related symptoms, safety and efficacy. MATERIALS AND METHODS: Patients with urolithiasis located proximal to the iliac vessel crossing, requiring stenting in preparation for secondary ureterorenoscopy (URS) were randomized to standard ureteric stenting or a suture stent. Secondary ureterorenoscopy was performed 2-6 weeks later. The Ureteral Stent Symptoms Questionnaire (USSQ) was completed after 1 week, on the day before URS and 2-6 weeks after stent removal. Stent efficacy and safety were systematically assessed. RESULTS: A total of 88 patients were included in the analysis. The median (range) suture stent length was 10 (5-25) cm vs 26 cm for standard stents. Operation time was longer for insertion of the suture stent (24.0 vs 14.5 min; P < 0.001). Patients with a suture stent had a significantly lower USSQ urinary symptoms score 1 week after stent insertion, adjusted for baseline symptoms by subtracting scores from the final visit without indwelling stent (mean 7.1 vs 13.7, difference -6.6, 95% confidence interval [CI] -3.4 to -9.8; P < 0.001). Prior to secondary URS (after 2-6 weeks), baseline-adjusted urinary symptoms (mean 4.7 vs 12.2, difference -7.5, 95% CI -4.5 to -10.4; P < 0.001) and pain subscores (11.5 vs 17.6, difference -6.1, 95% CI -0.7 to -11.6; P = 0.004) were significantly lower in the suture stent group. All other USSQ subscores showed no significant differences. Adverse events occurred in 15 patients and were similarly frequent in the two groups. No significant differences were found between the groups regarding ureteric access during secondary URS. CONCLUSION: Replacement of the distal part of ureteric stents by a suture can reduce stent-associated symptoms without restrictions regarding secondary stone removal or safety.

Considering non-bladder aetiologies of overactive bladder: a functional neuroimaging study.

OBJECTIVES: To better understand the neuropathophysiology of overactive bladder (OAB) in women by characterising supraspinal activity in response to bladder distention and cold stimulation. SUBJECTS/PATIENTS AND METHODS: We recruited 24 female participants, 12 with OAB (median [interquartile range, IQR] age 40 [32-42] years) and 12 healthy controls (HCs) without lower urinary tract (LUT) symptoms (median [IQR] age 34 [28-44] years), and assessed LUT and cognitive function through neuro-urological examination, 3-day bladder diary, urodynamic investigation, and questionnaires. Functional magnetic resonance (MR) imaging using a 3-T scanner was performed in all participants during automated, repetitive bladder filling and draining (block design) with 100 mL body temperature (37 °C) saline using a MR-compatible and MR-synchronised infusion-drainage device until strong desire to void (HIGH-FILLING/DRAINING) and bladder filling with cold saline (4 °C, i.e. COLD). Whole-brain and region-of-interest analyses were conducted using Statistical Parametric Mapping, version 12. RESULTS: Significant between-group differences were found for 3-day bladder diary variables (i.e. voiding frequency/24 h, P < 0.001; voided volume/void, P = 0.04; and urinary incontinence [UI] episodes/24 h, P = 0.007), questionnaire scores (International Consultation on Incontinence Questionnaire-Female LUT symptoms [overall, filling, and UI scores, all P < 0.001]; the Overactive Bladder Questionnaire short form [symptoms and quality-of-life scores, both P < 0.001]; the Hospital Anxiety and Depression Scale [anxiety P = 0.004 and depression P = 0.003 scores]), as well as urodynamic variables (strong desire to void, P = 0.02; maximum cystometric capacity, P = 0.007; and presence of detrusor overactivity, P = 0.002). Age, weight and cognitive function (i.e. Mini-Mental State Examination, P = 1.0) were similar between groups (P > 0.05). In patients with OAB, the HIGH task elicited activity in the superior temporal gyrus, ventrolateral prefrontal cortex (VLPFC), and mid-cingulate cortex; and the COLD task elicited activity in the VLPFC, cerebellum, and basal ganglia. Compared to HCs, patients with OAB showed significantly stronger cerebellar activity during HIGH-FILLING and significantly less activity in the insula and VLPFC during HIGH-DRAINING. CONCLUSIONS: The present findings suggest a sensory processing and modulation deficiency in our OAB group, probably as part of their underlying pathophysiology, as they lacked activity in essential sensory processing areas, such as the insula. Instead, accessory areas, such as the cerebellum, showed significantly stronger activation compared to HCs, presumably supporting pelvic-floor motor activity to prevent UI. The novel findings of the present study provide physiological evidence of the necessity to consider non-bladder aetiologies of bladder symptoms.

Ejaculatory disorders after prostatic artery embolization: a reassessment of two prospective clinical trials.

PURPOSE: This study aims to specify and explain the previous findings of unexpectedly high rates of ejaculatory disorders, i.e. 56%, found after prostatic artery embolization (PAE) in a randomized controlled trial comparing safety and efficacy of PAE and transurethral resection of the prostate (TURP). PATIENTS AND METHODS: Case report forms of the randomized controlled trial were analyzed to specify the grade of postoperative ejaculatory dysfunction 3 months postoperatively. In addition, study participants with assessable ejaculation were asked to complete the four-item Male Sexual Health Questionnaire-Ejaculation Dysfunction Short Form (MSHQ-EjD) referring to their ejaculatory function at present, as well as before treatment and 3 months after. Potential explanations for ejaculatory disorders after PAE were derived from histological examination of five radical prostatectomy specimens of patients that underwent PAE 6 weeks before radical prostatectomy within a proof-of-concept trial at the study site, St. Gallen Cantonal Hospital. An experienced uropathologist systematically examined the whole-gland embedded tissue with focus on structures that are involved into ejaculation. RESULTS: While patients after TURP predominantly suffered from anejaculation (52%), diminished ejaculation was found more often after PAE (40%). Significantly higher MSHQ-EjD scores were found 3 months after PAE and at a median follow-up of 31 months. Histological examination showed marked changes of structures involved into ejaculation (e.g., prostatic glands, seminal vesicles, ejaculatory ducts) after PAE. CONCLUSION: Although anejaculation occurs less frequently after PAE (16%) compared to TURP (52%), patients have to be informed about the relevant risk of ejaculatory disorders, especially diminished ejaculation.

Outcome prediction of prostatic artery embolization: post hoc analysis of a randomized, open-label, non-inferiority trial.

OBJECTIVES: To identify predictors for different treatment outcomes after prostatic artery embolization (PAE) in the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. PATIENTS AND METHODS: A post hoc analysis of data derived from the 48 patients undergoing PAE in a randomized, open-label, non-inferiority trial was performed. Relative changes in the International Prostate Symptoms Score (IPSS), absolute changes in maximum urinary flow rate (Qmax ), and relative changes in magnetic resonance imaging-assessed prostate volume from baseline to 12 weeks were defined as the outcomes measures of interest. Their association with various baseline characteristics and measures, technical details of PAE, and early postoperative measures were analysed using Spearman rank correlations and Wilcoxon rank-sum tests. The most promising predictors were further evaluated in receiver-operating characteristic (ROC) curve analyses. RESULTS: Higher total prostate and central gland (i.e. central plus transitional zone) volumes were associated with more pronounced improvements in the IPSS (Spearman rank correlation [rs]: -0.35 and -0.34; P = 0.01 and P = 0.02, respectively) and the Qmax (rs: 0.31 and 0.39; P = 0.05 and P = 0.01, respectively). ROC curve analyses suggested that volumes of 39 and 38 mL for total prostate and central gland volume, respectively, would be the optimal thresholds with which to predict PAE success as measured by the IPSS. Other anatomical characteristics of the prostate, such as the central gland index, also showed an even more distinct correlation to the improvement in Qmax (rs: 0.46, P = 0.003). The relative changes in prostate volume were clearly dependent on the technical performance of PAE. Occurrence of postoperative pain and blood levels of prostate-specific antigen and C-reactive protein emerged as potential early-stage outcome predictors after PAE. CONCLUSION: Baseline and peri-operative findings might help to guide patient selection and outcome prediction for PAE. Patients with larger prostates have a higher chance of success with PAE. Larger-scale clinical trials including a longer follow-up are warranted to further elucidate the most suitable patients for PAE.

In-hospital cost analysis of prostatic artery embolization compared with transurethral resection of the prostate: post hoc analysis of a randomized controlled trial.

OBJECTIVES: To perform a post hoc analysis of in-hospital costs incurred in a randomized controlled trial comparing prostatic artery embolization (PAE) and transurethral resection of the prostate (TURP). PATIENTS AND METHODS: In-hospital costs arising from PAE and TURP were calculated using detailed expenditure reports provided by the hospital accounts department. Total costs, including those arising from surgical and interventional procedures, consumables, personnel and accommodation, were analysed for all of the study participants and compared between PAE and TURP using descriptive analysis and two-sided t-tests, adjusted for unequal variance within groups (Welch t-test). RESULTS: The mean total costs per patient (±sd) were higher for TURP, at €9137 ± 3301, than for PAE, at €8185 ± 1630. The mean difference of €952 was not statistically significant (P = 0.07). While the mean procedural costs were significantly higher for PAE (mean difference €623 [P = 0.009]), costs apart from the procedure were significantly lower for PAE, with a mean difference of €1627 (P < 0.001). Procedural costs of €1433 ± 552 for TURP were mainly incurred by anaesthesia, whereas €2590 ± 628 for medical supplies were the main cost factor for PAE. CONCLUSIONS: Since in-hospital costs are similar but PAE and TURP have different efficacy and safety profiles, the patient's clinical condition and expectations - rather than finances - should be taken into account when deciding between PAE and TURP.

Predictability and Inducibility of Detachment of Prostatic Central Gland Tissue after Prostatic Artery Embolization: Post Hoc Analysis of a Randomized Controlled Trial.

PURPOSE: To assess the frequency and potential predictors of prostatic central gland tissue detachment (CGD), an enucleation-like reaction that sporadically occurred in a randomized controlled trial assessing efficacy and safety of prostatic artery embolization (PAE). MATERIALS AND METHODS: Trial data were analyzed to identify patients with CGD after PAE. Clinical parameters, MR imaging findings, technical details of PAE, and periinterventional data were compared between patients with and without CGD to identify parameters for prediction, induction, or early detection of CGD after PAE. RESULTS: CGD occurred after PAE in 3 of 48 patients (6.3%); these cases had good functional outcomes, but CGD was associated with increased risk of ejaculatory dysfunction and occurrence of complications. Frequency of preoperative transurethral bladder catheterization (100% vs 13.3%; P = .005), central gland index (mean ± standard deviation, 0.86 ± 0.02 vs 0.69 ± 0.14; P < .001), amount of particles applied (1.93 mL ± 0.12 vs 0.96 mL ± 0.36; P < .001), maximum early postoperative pain score (7.33 ± 2.08 vs 1.89 ± 2.40; P = .009), and blood C-reactive protein (CRP) levels after 48 hours (69.0 vs 18.58 mg/dL; P = .045) and 1 week (113.50 vs 5.16 mg/dL; P = .004) were significantly higher in cases of CGD. CONCLUSIONS: CGD is a rare reaction that might be triggered by prostatic zonal anatomy, embolization technique, and mechanical or inflammatory processes. It should be considered in patients with severe postoperative pain and high CRP levels who experience voiding dysfunction after PAE to avoid complications. Investigation of larger cohorts might further elucidate this tissue response.

Detection of microbial colonization of the urinary tract of patients prior to secondary ureterorenoscopy is highly variable between different types of assessment: results of a prospective observational study.

This study compares the findings of different detection methods for microorganisms in patients with ureteral stents undergoing secondary ureterorenoscopy including the use of a novel validated examination pipeline for biofilms on ureteral stents. Of the included 94 patients, 21.3% showed bacteriuria in preoperative urine cultures. Intraoperative urine culture showed bacteriuria in four (4.3%) of the patients. Stent biofilm cultures were positive in 12.9% and qPCR detected bacterial DNA in 18.1%. The findings of the different examinations were poorly correlated with each other. Detection of microorganisms in the urinary tract of patients with indwelling ureteral stents is highly dependent on timing (i.e. pre- vs intraoperative) and method of assessment. Preoperative routine urine cultures are not predictive for intraoperative urine- and stent culture. These results cast doubt on the clinical relevance of enterococcal species, staphylococci, and streptococci if identified preoperatively prior to stent removal. The timing of oral preoperative antibiotic prophylaxis might need to be reconsidered.

PSA bounce after ¹²5I-brachytherapy for prostate cancer as a favorable prognosticator.

BACKGROUND: Permanent low-dose-rate brachytherapy (BT) with iodine 125 is an established curative treatment for localized prostate cancer. After treatment, prostate-specific antigen (PSA) kinetics may show a transient rise (PSA bounce). Our aim was to investigate the association of PSA bounce with biochemical control. PATIENTS AND METHODS: Patients treated with BT in Switzerland were registered in a prospective database. Only patients with a follow-up of at least 2 years were included in our analysis. Clinical follow-up and PSA measurements were assessed after 1.5, 3, 6, and 12 months, and annually thereafter. If PSA increased, additional follow-up visits were scheduled. Cases of PSA bounce were defined as a rise of at least 0.2 ng/ml above the initial PSA nadir with a subsequent decline to or below the initial nadir without treatment. Biochemical failure was defined as a rise to nadir + 2 ng/ml. RESULTS: Between March 2001 and November 2010, 713 patients with prostate cancer undergoing BT with at least 2 years of follow-up were registered. Median follow-up time was 41 months. Biochemical failure occurred in 28 patients (3.9 %). PSA bounce occurred in 173 (24.3 %) patients; only three (1.7 %) patients with PSA bounce developed biochemical failure, in contrast to 25 (4.6 %) patients without previous bounce (p < 0.05). The median time to bounce was 12 months, the median time to biochemical failure was 30 months. The median bounce increase was 0.78 ng/ml. Twenty-eight patients with bounce (16.5 %) had a transient PSA rise of + 2 ng/ml above the nadir. CONCLUSION: In most cases, an early increase in PSA after BT indicates PSA bounce and is associated with a lower risk of biochemical failure.

How do stone attenuation and skin-to-stone distance in computed tomography influence the performance of shock wave lithotripsy in ureteral stone disease?

BACKGROUND: Shock wave lithotripsy (SWL) is a noninvasive, safe, and efficient treatment option for ureteral stones. Depending on stone location and size, the overall stone-free rate (SFR) varies significantly. Failure of stone disintegration results in unnecessary exposure to shock waves and radiation and requires alternative treatment procedures, which increases medical costs. It is therefore important to identify predictors of treatment success or failure in patients who are potential candidates for SWL before treatment. Nowadays, noncontrast computed tomography (NCCT) provides reliable information on stone location, size, number, and total stone burden. The impact of additional information provided by NCCT, such as skin-to-stone distance (SSD) and mean attenuation value (MAV), on stone fragmentation in ureteral stone disease has hardly been investigated separately so far. Thus, the objective of this study was to assess the influence of stone attenuation, SSD and body mass index (BMI) on the outcome of SWL in ureteral stones. METHODS: We reviewed the medical records of 104 patients (80 men, 24 women) with ureteral stone disease treated consecutively at our institution with SWL between 2010 and 2013. MAV in Hounsfield Units (HU) and SSD were determined by analyzing noncontrast computed tomography images. Outcome of SWL was defined as successful (visible stone fragmentation on kidney, ureter, and bladder film (KUB)) or failed (absent fragmentation on KUB). RESULTS: Overall success of SWL was 50% (52 patients). Median stone attenuation was 956.9 HU (range 495-1210.8) in the group with successful disintegration and 944.6 (range 237-1302) in the patients who had absent or insufficient fragmentation. Median SSD was 125 mm (range 81-165 mm) in the group treated successfully and 141 mm (range 108-172 mm) in the patients with treatment failure. Unlike MAV (p = 0.37), SSD (p < 0.001) and BMI (p = 0.008) significantly correlated with treatment outcome. CONCLUSION: The choice of treatment for ureteral stones should be based on stone location and size as considered in the AUA and EAU guidelines on urinary stone disease. In ambiguous cases, SSD and BMI can be used to assist in the decision. In this study, MAV showed no correlation with fragmentation rate of SWL.

Sacral neuromodulation for the treatment of neurogenic lower urinary tract dysfunction caused by multiple sclerosis: a single-centre prospective series.

BACKGROUND: Sacral neuromodulation is well established in the treatment of refractory, non-neurogenic lower urinary tract dysfunction, but its efficacy and safety in patients with lower urinary tract dysfunction of neurological origin is unclear. Only few case series have been reported for multiple sclerosis. We prospectively evaluated the efficacy and safety of sacral neuromodulation in patients with multiple sclerosis. METHODS: Seventeen patients (13 women, 4 men) treated with sacral neuromodulation for refractory neurogenic lower urinary tract dysfunction caused by multiple sclerosis were prospectively enrolled (2007-2011). Patients had to have stable disease and confirmed neurogenic lower urinary tract dysfunction. Voiding variables, adverse events, and subjective satisfaction were assessed. RESULTS: Sixteen (94 %) patients had a positive test phase with a >70 % improvement. After implantation of the pulse generator (InterStim II), the improvement in voiding variables persisted. At 3 years, the median voided volume had improved significantly from 125 (range 0 to 350) to 265 ml (range 200 to 350) (p < 0.001), the post void residual from 170 (range 0 to 730) to 25 ml (range 0 to 300) (p = 0.01), micturition frequency from 12 (range 6 to 20) to 7 (range 4 to 12) (p = 0.003), and number of incontinence episodes from 3 (range 0 to 10) to 0 (range 0 to 1) (p = 0.006). The median subjective degree of satisfaction was 80 %. Only two patients developed lack of benefit. No major complications occurred. CONCLUSIONS: Chronic sacral neuromodulation promises to be an effective and safe treatment of refractory neurogenic lower urinary tract dysfunction in selected patients with multiple sclerosis.

Is absorption of irrigation fluid a problem in Thulium laser vaporization of the prostate? A prospective investigation using the expired breath ethanol test.

BACKGROUND: Benign prostatic hyperplasia (BPH) is a prevalent entity in elderly men. If medical treatment fails, monopolar transurethral resection of the prostate (TUR-P) is still considered as the standard treatment. The proportion of high-risk patients with cardiac comorbidities increases and TUR-P goes along with a relevant perioperative risk. Especially large volume influx of irrigation fluid and transurethral resection syndrome (TUR syndrome) represent serious threats to these patients. Using isotonic saline as irrigation fluid like in transurethral laser vaporization (TUV-P), TUR syndrome can be prevented. However, no prospective trial has ever assessed occurrence or extent of irrigation fluid absorption in Thulium Laser TUV-P. METHODS/DESIGN: This is a single-center prospective trial, investigating, if absorption of irrigation fluid occurs during Thulium Laser TUV-P by expired breath ethanol test. The expired breath ethanol technique is an established method of investigating intraoperative absorption of irrigation fluid: A tracer amount of ethanol is added to the irrigation fluid and the absorption of irrigation fluid can be calculated by measuring the expiratory ethanol concentrations of the patient with an alcohol breathalyzer. Fifty consecutive patients undergoing TUV-P at our tertiary referral center are included into the trial. Absorption volume of irrigation fluid during Thulium Laser TUV-P is defined as primary endpoint. Pre- to postoperative changes in bladder diaries, biochemical and hematological laboratory findings, duration of operation and standardized questionnaires are assessed as secondary outcome measures. DISCUSSION: The aim of this study is to assess the safety of Thulium Laser TUV-P in regard to absorption of irrigation fluid.

Prostatic artery embolization versus conventional TUR-P in the treatment of benign prostatic hyperplasia: protocol for a prospective randomized non-inferiority trial.

BACKGROUND: Benign prostatic hyperplasia (BPH) is a prevalent entity in elderly men and transurethral resection of the prostate (TURP) still represents the gold standard of surgical treatment despite its considerable perioperative morbidity. Recently, prostatic artery embolization (PAE) was described as a novel effective and less invasive treatment alternative. Despite promising first results, PAE still has to be considered experimental due to a lack of good quality studies. Prospective randomized controlled trials comparing PAE with TUR-P are highly warranted. METHODS/DESIGN: This is a single-centre, prospective, randomized, non-inferiority trial comparing treatment effects and adverse events of PAE and TURP in a tertiary referral centre. One hundred patients who are electable for both treatment options are randomized to either PAE or TURP. Changes of the International Prostate Symptom Score (IPSS) after 3 months are defined as primary endpoint. Changes in bladder diaries, laboratory analyses, urodynamic investigations and standardised questionnaires are assessed as secondary outcome measures. In addition contrast-enhanced magnetic resonance imaging of the pelvis before and after the interventions will provide crucial information regarding morphological changes and vascularisation of the prostate. Adverse events will be assessed on every follow-up visit in both treatment arms according to the National Cancer Institute Common Terminology Criteria for Adverse events and the Clavien classification. DISCUSSION: The aim of this study is to assess whether PAE represents a valid treatment alternative to TURP in patients suffering from BPH in terms of efficacy and safety. TRIAL REGISTRATION: ClinicalTrials.gov NCT02054013.

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.

Prostatic Artery Embolisation Versus Transurethral Resection of the Prostate for Benign Prostatic Obstruction: 5-year Outcomes of a Randomised, Open-label, Noninferiority Trial.

BACKGROUND AND OBJECTIVE: Prostatic artery embolisation (PAE) and transurethral resection of the prostate (TURP) are two of the surgical options for treatment of lower urinary tract symptoms/benign prostatic obstruction (LUTS/BPO). Our aim was to compare the efficacy and safety of PAE and TURP for LUTS/BPO treatment at long-term follow-up. METHODS: We conducted a randomised, open-label, single-centre trial at a Swiss tertiary care centre. The main outcome was the change in International Prostate Symptom Score (IPSS) after PAE versus TURP. Secondary outcomes included patient-reported outcomes, functional measures, and adverse events assessed at baseline and at 3, 6, 12, 24, and 60 mo. Between-group differences in the change from baseline to 5 yr were tested using two-sided Mann-Whitney and t tests. KEY FINDINGS AND LIMITATIONS: Of the 103 patients with refractory LUTS/BPO who were randomised between 2014 and 2017, 18/48 who underwent PAE and 38/51 who underwent TURP reached the 60-mo follow-up visit. The mean reduction in IPSS from baseline to 5 yr was -7.78 points after PAE and -11.57 points after TURP (difference 3.79 points, 95% confidence interval [CI] -0.66 to 8.24; p = 0.092). TURP was superior for most patient-reported secondary outcomes except for erectile function. At 5 yr, PAE was less effective than TURP regarding objective parameters, such as the improvement in maximum urinary flow rate (3.59 vs 9.30 ml/s, difference -5.71, 95% CI -10.72 to -0.70; p = 0. 027) and reduction in postvoid residual volume (27.81 vs 219.97 ml; difference 192.15, 95% CI 83.79-300.51; p = 0.001). CONCLUSIONS AND CLINICAL IMPLICATIONS: The improvement in LUTS/BPO at 5 yr after PAE was inferior to that achieved with TURP. The limitations of PAE should be considered during patient selection and counselling. PATIENT SUMMARY: In this study, we show the long-term results of prostate artery embolisation (PAE) in comparison to transurethral resection of the prostate (TURP) for the treatment of benign prostate enlargement causing urinary symptoms. PAE shows good long-term results in properly selected patients, although the improvements are less pronounced than with TURP. This trial is registered on ClinicalTrials.gov as NCT02054013.

Bipolar versus monopolar transurethral resection of the prostate: results of a comparative, prospective bicenter study--perioperative outcome and long-term efficacy.

OBJECTIVES: To compare bipolar and monopolar transurethral resection of the prostate (TURP) in a comparative prospective study at two urology centers. METHODS: Of 212 patients with symptomatic benign prostatic hyperplasia entered prospectively into the study, 111 underwent bipolar and 101 monopolar TURP. Patients were treated in two consecutive series with each surgical method at both centers. Improvement in peak flow rate, postvoid residual, International Prostate Symptom Score, and quality of life score postoperatively and at 3, 12, 24 and 36 months, as well as long-term adverse events were compared. Regarding safety, duration of surgery, postoperative catheterization and hospitalization time, amount of fluid absorption, frequency of transurethral resection (TUR) syndrome, and risk of hemorrhage were evaluated. RESULTS: Patient characteristics of the two series were comparable. The risk of developing TUR syndrome (p = 0.32) and bleeding tendency (p = 0.52) did not differ significantly between groups. Significant differences were seen for duration of surgery and resection speed. All functional parameters improved significantly during follow-up, with no relevant differences between surgical groups. CONCLUSIONS: Since no major differences in efficacy and safety were seen between the surgical groups, we feel that the monopolar technique still has a valuable place in TURP.

Myofascial Pelvic Pain: Best Orientation and Clinical Practice. Position of the European Association of Urology Guidelines Panel on Chronic Pelvic Pain.

CONTEXT: Despite the high prevalence of a myofascial pain component in chronic pelvic pain (CPP) syndromes, awareness and management of this component are lacking among health care providers. OBJECTIVE: To summarize the current state of the art for the management of myofascial pain in chronic primary pelvic pain syndromes (CPPPS) according to scientific research and input from experts from the European Association of Urology (EAU) guidelines panel on CPP. EVIDENCE ACQUISITION: A narrative review was undertaken using three sources: (1) information in the EAU guidelines on CPP; (2) information retrieved from the literature on research published in the past 3 yr on myofascial pelvic pain; and (3) expert opinion from panel members. EVIDENCE SYNTHESIS: Studies confirm a high prevalence of a myofascial pain component in CPPPS. Examination of the pelvic floor muscles should follow published recommendations to standardize findings and disseminate the procedure. Treatment of pelvic floor muscle dysfunction and pain in the context of CPP was found to contribute to CPP control and is feasible via different physiotherapy techniques. A multidisciplinary approach is the most effective. CONCLUSIONS: Despite its high prevalence, the myofascial component of CPP has been underevaluated and undertreated to date. Myofascial pain must be assessed in all patients with CPPPS. Treatment of the myofascial pain component is relevant for global treatment success. Further studies are imperative to reinforce and better define the role of each physiotherapy technique in CPPPS. PATIENT SUMMARY: Pain and inflammation of the body's muscle and soft tissues (myofascial pain) frequently occurs in pelvic pain syndromes. Its presence must be evaluated to optimize management for each patient. If diagnosed, myofascial pain should be treated.

The Benefits and Harms of Pharmacological Treatment for Postradiation Pelvic Pain: A Systematic Review by the European Association of Urology Chronic Pelvic Pain Panel with Recommendations for Clinical Practice.

Context: Radiotherapy of the pelvis is a widely used method for the treatment of malignancies, and local complications including pain following pelvic radiation therapy are acknowledged complications. Objective: The primary objective is to assess the clinical effectiveness and safety of pharmacological therapies on postradiation pelvic pain. Evidence acquisition: A systematic review of the use of different pharmacological treatments in the management of post-radiation pelvic pain was conducted (PROSPERO-ID: CRD42021249026). Comprehensive searches of EMBASE, Medline, and Cochrane library were performed for publications between January 1980 and April 2021. The primary outcomes were improvement in pain and adverse events following treatment. The secondary outcomes included quality of life, bowel function, and urinary function. Evidence synthesis: After screening 1514 abstracts, four randomised controlled trials were identified, enrolling 355 patients with bladder and anorectal subtypes of postradiotherapy chronic pelvic pain (CPP). A narrative synthesis was performed as heterogeneity of included studies precluded a meta-analysis. A single study reported a significant reduction in pain after 6 mo in patients with bladder pain syndrome treated with hyaluronic acid or hyperbaric oxygen. Anorectal pain was reported to be reduced by the application of 4% formalin, but the use of hyperbaric oxygen in postradiotherapy anorectal pain remains controversial. Adverse event reporting was generally poor. Studies looking at medications used routinely in guidelines for neuropathic pain, such as gabapentin, pregabalin, amitriptyline, and duloxetine, were absent or of poor quality when it came to postradiation pelvic pain. Conclusions: Beneficial effects of hyperbaric oxygen or formalin on pain, quality of life, and functional symptoms were seen in patients with certain CPP subtypes, but the current evidence level is too weak to allow recommendations about the use of any pharmacological treatment for postradiation pelvic pain. Patient summary: Different pharmacological treatments are used to treat pain after radiotherapy, but current studies are of insufficient quality to determine whether these should be recommended and many chronic pelvic pain subtypes are not covered. Further research is needed.