Transurethral water vapor ablation of the prostate with the Rezum system: Urodynamic findings.

AIMS: The efficacy of the transurethral convective interstitial radiofrequency water vapor thermal ablation of the prostate with the Rezum system for the treatment of male lower urinary tract symptom due to benign prostatic hyperplasia is well proven. The improvement of urodynamic parameters obtained from a simple uroflowmetry cannot measure the effect of water vapor injection on the bladder outlet obstruction. METHODS: This monocentric retrospective pilot study analyzes the data of pressure-flow studies performed before and after 17 Rezum procedures to answer the question whether thus obtained ablation of prostate tissue has a disobstructive effect on the bladder outlet. RESULTS: All the functional outcomes were consistently improved after the procedure, with a median flowrate increase of 5.1 ml/s (p = 0.0022) and a median postvoid residual urine (PVR) reduction of 100 ml (p = 0.0042). The prostate volume was reduced by 40% (p < 0.0001) and the median Bladder Outlet Obstruction Index (BOOI) reduction was 53.8 (p < 0.0001). CONCLUSIONS: These data show that the possibility to significantly reduce the obstruction grade with even a single Rezum procedure is concrete and seems to be independent from the degree of the obstruction grade.

Bilateral Peritoneal Flaps Reduce Incidence and Complications of Lymphoceles after Robotic Radical Prostatectomy with Pelvic Lymph Node Dissection-Results of the Prospective Randomized Multicenter Trial ProLy.

PURPOSE: The purpose of this study was to investigate the effect of a surgically constructed bilateral peritoneal flap (PIF) as an adjunct to robot-assisted radical prostatectomy (RARP) and pelvic lymph node dissection (PLND) on the incidence of lymphoceles. MATERIALS AND METHODS: A total of 530 men with localized prostate cancer underwent a RARP with bilateral extended standardized PLND in a prospective randomized controlled trial. In group A, a PIF was created by suturing the margins of the bladder peritoneum to the ipsilateral endopelvic fascia at 2 points on each side. In group B, no PIF was created. The patients were followed 30 and 90 days after the surgery to assess the incidence, extent and treatment of lymphoceles. RESULTS: Lymphoceles occurred in 22% of group A patients and 33% of group B patients (p=0.008). Symptomatic lymphoceles were observed in 3.3% of group A patients and 8.1% of group B patients (p=0.027). Lymphoceles requiring intervention occurred significantly less frequently in group A patients (1.3%) than in group B patients (6.8%, p=0.002). The median lymphocele size was 4.3 cm in group A and 5.0 cm in group B (p=0.055). No statistically significant differences were observed in minor or major complications unrelated to lymphocele, blood loss, or surgical time between groups A and B. CONCLUSIONS: Bilateral PIFs in conjunction with RARP and PLND significantly reduce the total incidence of lymphoceles, the frequency of symptomatic lymphoceles and the rate of associated secondary interventions.

Impact of obesity on perioperative, functional and oncological outcomes after robotic-assisted radical prostatectomy in a high-volume center.

OBJECTIVE: To compare surgical, oncological and functional outcomes between obese vs. normal-weight prostate cancer (PCa) patients treated with robotic-assisted radical prostatectomy (RARP). MATERIALS AND METHODS: We assessed 4555 consecutive RARP patients from a high-volume center 2008-2018. Analyses were restricted to normal-weight vs. obese patients (≥ 30 kg/m2). Multivariable cox regression analyses (MVA) assessed the effect of obesity on biochemical recurrence (BCR), metastatic progression (MP), erectile function and urinary continence recovery. Analyses were repeated after propensity score matching. RESULTS: Before matching, higher rates of pathological Gleason Grade group ≥ 4 (14 vs. 18%; p = 0.004) and pT3 stage (33 vs. 35%; p = 0.016) were observed in obese patients, with similar observations for surgery time, blood loss and 30-day wound- and surgical complication rates. For normal-weight vs. obese patients, BCR- and MP-free rates were 86 vs. 85% (p = 0.97) and 97.5 vs.97.8% (p = 0.8) at 48 months. Similarly, rates of erectile function at 36 months and urinary continence at 12 months were 56 vs. 49% (p = 0.012) and 88 vs. 85% (p = 0.003), respectively. Before and after propensity score matching, obesity had no effect on BCR or MP, but a negative effect on erectile function (matched HR 0.87, 95%CI 0.76-0.99; p = 0.029) and urinary continence recovery (matched HR 0.91, 95%CI 0.84-0.98; p = 0.014). CONCLUSIONS: Obesity did not represent a risk factor of BCR or MP after RARP despite higher rates of adverse pathological features. However, obesity was associated with higher risk of perioperative morbidity and impaired functional outcomes. Such information is integral for patient counselling. Thus, weight loss before RARP should be encouraged.

Feasibility of robot-assisted radical prostatectomy in men at senior age ≥75 years: perioperative, functional, and oncological outcomes of a high-volume center.

OBJECTIVES: The aim of this study was to assess whether age ≥75 years impairs surgical, functional, and oncological outcomes after robot-assisted radical prostatectomy (RARP). MATERIALS AND METHODS: Patients with prostate cancer (PCa) were stratified in ≥75(n = 669) vs. <70 years(n = 8,268). Multivariable cox regression analyses (MVA) tested for effect of senior age on erectile function-, urinary continence-recovery, biochemical recurrence (BCR), and metastatic progression (MP). RESULTS: RARP duration, blood loss, and 30d complication rates were similar between groups. For patients ≥75 vs. <70 years, rates of erectile function after 36 and urinary continence after 12 months were 27 vs. 56% (p < 0.001) and 85 vs. 86% (p = 0.99), respectively. Mean quality of life (QoL) score after 12 months improved in both groups (p = 0.9). At 48 months, BCR- and MP-free rates were 77 vs. 85% (p < 0.001) and 97 vs. 98% (p = 0.3), respectively. MVA confirmed the negative effect of senior age on erectile function but no significant effect on urinary continence, BCR or MP, before and after propensity score matching. CONCLUSION: Apart from erectile function, senior age has no significant effect on urinary continence recovery, BCR- or MP-free rates after RARP. Post-RARP QoL improved even in senior patients. Modern therapy of senior PCa patients should be based on individual counseling than just age.

Muscarinic-3-receptor positive allosteric modulator ASP8302 in patients with underactive bladder. A randomized controlled trial.

AIM: The aim of this study is to evaluate safety and efficacy of ASP8302, a novel positive allosteric modulator for the muscarinic M3 receptor (M3-PAM), in patients with underactive bladder (UAB). METHODS: A randomized, double-blind, placebo-controlled multicenter study was performed in adult male/female subjects with UAB, defined as incomplete bladder emptying (postvoid residual volume [PVR] > 100 ml) without significant bladder outlet obstruction and/or overactive bladder. Subjects were randomized (1:1) to receive 4-week oral once-daily administration of 100 mg ASP8302 or matching placebo. Primary endpoint was a change from baseline in PVR measured by catheterization after standardized bladder filling (PVRC2 ). Other endpoints included PVR and bladder voiding efficiency (BVE) measured in various ways, uroflowmetry, bladder diary, and questionnaires. Pressure-flow studies were performed in a subgroup. RESULTS: One hundred and thirty-five patients were randomized (ASP8302 group: 65 patients, placebo group: 70 patients). The median change in PVRC2 was -40.0 ml (ASP8302) versus -35.0 ml (placebo) and the difference between groups was -5.0 ml (p = 0.960). In males, functional and symptomatic outcomes improved, for example, maximum urine flow rate (Qmax ) and detrusor pressure at Qmax (Pdet.Qmax ) increased (mean difference in change ASP8302 vs. placebo: 3.8 ml/s, p = 0.031 and 12.7 cm H2 O, p = 0.034, respectively). Urinary incontinence episodes/24 h decreased in males with preexisting incontinence (mean difference: -0.35; p = 0.028). The incidence of adverse events was similar between study groups (ASP8302: 33.3%, placebo: 31.4%). In the included subjects, both baseline urine flow and bladder voiding pressure was low. Compared with PVR, simultaneous BVE measurements were more consistent between various methods (spontaneous vs. standardized bladder filling, catheterization vs. ultrasound [US]). CONCLUSIONS: ASP8302 was safe and well tolerated in patients with UAB identified by nonurodynamic clinical criteria, but it did not show efficacy in the primary endpoint. However, in males it showed improvement of symptoms and functional parameters. BVE (using US) is a more optimal outcome measure than PVR in UAB.

Development of a Management Algorithm for Acute and Chronic Radiation Urethritis and Cystitis.

OBJECTIVE: The purpose of this review was to summarize the current literature on the assessment and treatment of radiation urethritis and cystitis (RUC) for the development of an evidenced-based management algorithm. MATERIAL AND METHODS: The PubMed/MEDLINE database was searched by a multidisciplinary group of experts in January 2021. RESULTS: In total, 48 publications were identified. Three different types of RUC can be observed in clinical practice: inflammation-predominant, bleeding-predominant, and the combination of inflammation- and bleeding-RUC. There is no consensus on the optimal treatment of RUC. Inflammation-predominant RUC should be treated symptomatically based on the existence of bothersome storage or voiding lower urinary tract symptom as well as on pain. When bleeding-predominant RUC has occurred, hydration and hyperbaric oxygen therapy (HOT) should be used first and, if HOT is not available, oral drugs instead (sodium pentosane polysulfate, aminocaproic acid, immunokine WF 10, conjugated estrogene, or pentoxifylline + vitamin E). If local bleeding persists, focal therapy of bleeding vessels with a laser or electrocoagulation is indicated. In case of generalized bleeding, intravesical installation should be initiated (formalin, aluminium salts, and hyaluronic acid/chondroitin). Vessel embolization is a less invasive treatment with potentially less complications and good clinical outcomes. Open- or robot-assisted surgery is indicated in patients with permanent, life-threatening bleeding, or fistulae. CONCLUSIONS: Treatment of RUC, if not self-limiting, should be done according to the type of RUC and in a stepwise approach. Conservative/medical treatment (oral and topic agents) should primarily be used before invasive (transurethral) treatments.

Perioperative and Postoperative Outcomes of Robot-Assisted Radical Prostatectomy in Prostate Cancer Patients with Prior Transurethral Subvesical Deobstruction: Results of a High-Volume Center.

PURPOSE: Prostate cancer patients who are scheduled for robot-assisted radical prostatectomy often have a history of transurethral resection or laser enucleation of the prostate as treatment of benign prostatic hyperplasia. We examined if these patients have impaired surgical, functional and oncologic outcomes compared to those who have no symptom burden of moderate to severe benign prostatic hyperplasia and no previous transurethral resection or laser enucleation of the prostate. MATERIALS AND METHODS: We compared 368 robot-assisted radical prostatectomy patients with previous transurethral resection or laser enucleation of the prostate (group A) to 4,945 robot-assisted radical prostatectomy patients without transurethral resection or laser enucleation of the prostate and without moderate or severe benign prostatic hyperplasia symptoms (group B) at a high-volume robot-assisted radical prostatectomy center. Multivariable Cox regression analyses assessed impact of transurethral resection or laser enucleation of the prostate on erectile function and urinary continence recovery, biochemical recurrence or metastatic progression. Analyses were repeated after propensity score matching. RESULTS: No relevant differences in surgical outcomes, such as surgical margin and 30-day complications rates, were observed. Urinary continence recovery rates at 12 months were 67% vs 74% (group A vs B; p <0.001). Erectile function recovery rates at 24 months were 52% vs 62% (p <0.001). Biochemical recurrence-free rates at 36 months were identical, at 87.3% vs 87.8%. Before and after propensity score matching, transurethral resection or laser enucleation of the prostate negatively affected erectile function recovery (matched HR 0.68, 95% CI 0.53-0.88; p=0.003) in multivariable Cox regression analyses. Similarly, transurethral resection or laser enucleation of the prostate had negative effect on urinary continence recovery (HR 0.84, 95% CI 0.73-0.97; p=0.015) but no effect on biochemical recurrence or metastatic progression. CONCLUSIONS: Previous transurethral resection or laser enucleation of the prostate does not negatively impact surgical, complication-related, and oncologic outcomes if the robot-assisted radical prostatectomy is performed by highly experienced surgeons. However, transurethral resection or laser enucleation of the prostate negatively affects erectile function and urinary continence recovery.

Impact of early vs. delayed initiation of dutasteride/tamsulosin combination therapy on the risk of acute urinary retention or BPH-related surgery in LUTS/BPH patients with moderate-to-severe symptoms at risk of disease progression.

PURPOSE: To evaluate the effect of delayed start of combination therapy (CT) with dutasteride 0.5 mg and tamsulosin 0.4 mg on the risk of acute urinary retention or benign prostatic hyperplasia (BPH)-related surgery (AUR/S) in patients with moderate-to-severe lower urinary tract symptoms (LUTS) at risk of disease progression. METHODS: Using a time-to-event model based on pooled data from 10,238 patients from Phase III/IV dutasteride trials, clinical trial simulations (CTS) were performed to assess the risk of AUR/S up to 48 months in moderate-to-severe LUTS/BPH patients following immediate and delayed start of CT for those not responding to tamsulosin monotherapy. Simulation scenarios (1300 subjects/arm) were investigated, including immediate start (reference) and alternative delayed start (six scenarios 1-24 months). AUR/S incidence was described by Kaplan-Meier survival curves and analysed using log-rank test. The cumulative incidence of events as well as the relative and attributable risks were summarised stratified by treatment. RESULTS: Survival curves for patients starting CT at month 1 and 3 did not differ from those who initiated CT immediately. By contrast, significant differences (p < 0.001) were observed when switch to CT occurs ≥ 6 months from the initial treatment. At month 48, AUR/S incidence was 4.6% vs 9.5%, 11.0% and 11.3% in patients receiving immediate CT vs. switchers after 6, 12 and 24 months, respectively. CONCLUSIONS: Start of CT before month 6 appears to significantly reduce the risk of AUR/S compared with delayed start by ≥ 6 months. This has implications for the treatment algorithm for men with LUTS/BPH at risk of disease progression.

Model-based meta-analysis of the time to first acute urinary retention or benign prostatic hyperplasia-related surgery in patients with moderate or severe symptoms.

AIMS: Combination therapy of 5α-reductase inhibitor and α-blocker is a guideline-endorsed therapeutic approach for patients with moderate-to-severe lower urinary tract symptoms or benign prostatic hyperplasia (LUTS/BPH) who are at risk of disease progression. We aimed to disentangle the contribution of clinical and demographic baseline characteristics affecting the risk of acute urinary retention or BPH-related surgery (AUR/S) from the effect of treatment with drugs showing symptomatic and disease-modifying properties. METHODS: A time-to-event model was developed using pooled data from patients (n = 10 238) enrolled into six clinical studies receiving placebo, tamsulosin, dutasteride or tamsulosin-dutasteride combination therapy. A parametric hazard function was used to describe the time to first AUR/S. Covariate model building included the assessment of relevant clinical and demographic factors on baseline hazard. Predictive performance was evaluated by graphical and statistical methods. RESULTS: An exponential hazard model best described the time to first AUR/S in this group of patients. Baseline International Prostate Symptom Score, prostate-specific antigen, prostate volume and maximum urine flow were identified as covariates with hazard ratio estimates of 1.04, 1.08, 1.01 and 0.91, respectively. Dutasteride monotherapy and tamsulosin-dutasteride combination therapy resulted in a significant reduction in the baseline hazard (56.8% and 66.4%, respectively). By contrast, the effect of tamsulosin did not differ from placebo. CONCLUSIONS: Our analysis showed the implications of disease-modifying properties of dutasteride and tamsulosin-dutasteride combination therapy for the risk of AUR/S. It also elucidated the contribution of different baseline characteristics to the risk of these events. The use of tamsulosin monotherapy (symptomatic treatment) has no impact on individual long-term risk.

What are the chances of improvement or cure from overactive bladder? A pooled responder analysis of efficacy and treatment emergent adverse events following treatment with fesoterodine.

AIM: This study describes patients with different degrees and combinations of symptom resolution in response to fesoterodine exposure to aid physicians in counselling patients with overactive bladder (OAB) on the likelihood of treatment success. METHODS: Data came from 12-week fixed-dose studies of fesoterodine. The proportions of patients experiencing symptom resolution and change in patient-reported outcome measures (PROM) at 4, 8, and 12 weeks were calculated. Treatment-emergent adverse events (TEAE) were reported according to response in urinary urgency episodes (UUE). The relationship between PROM and response was examined. RESULTS: Out of 6689 patients, 81.6% female, urgency urinary incontinence (UUI) episodes/24 h were more responsive to fesoterodine than UUE; with roughly 50% of patients reporting a 50% reduction and fewer than 10% reporting absence of UUE at 12 weeks compared to approximately 40%-50% reporting absence of UUI. TEAE was numerically lower in patients with greater response. There was a statistically significant relationship between improvement in urinary urgency and associated change in OAB-q symptom bother scores, r = 0.54, p < 0.001. At Week 4, 64.0%-76.7% of patients who had achieved a significant change in Patient Perception of Bladder Condition (PPBC) had a 50% reduction in UUI. At Week 12 this proportion was between 80% and 87.9%, with those being exposed to fesoterodine treatment reporting response in PPBC at numerically higher rates. CONCLUSION: These data provide clinicians with information from which they may usefully communicate the likelihood of symptom resolution in response to pharmacotherapy for OAB and answer a key clinical question posed by many care providers. Roughly ⅓ of fesoterodine treated patients reported a 50% reduction urgency and ¾ reported 50% resolution of incontinence at 12 weeks. Total resolution of all symptoms was seldom achieved.

Which drugs are best for overactive bladder? From patients' expectations to physicians' decisions.

AIM: In order to help physicians determine which drugs are the best for treating overactive bladder (OAB) symptoms, this review considered three questions: what are the patient's expectations? What information is generated by the Multicriteria Decision Analysis (MCDA) model? What can physicians expect from medical treatments? METHODS: A comprehensive literature search was undertaken on these three topics in order to assist physicians regarding the optimum treatment modality for OAB. RESULTS: Patients' difficulties in reporting symptoms and their expectations of treatment outcomes interfere with the success of treatment. To assist physicians in meeting patients' expectations and to choose the most appropriate treatment, a new approach, recognised by the European Medicines Agency, the MCDA model was used to compare the benefits and safety of OAB treatments. CONCLUSION: The MCDA model is useful for comparing the benefit-safety profiles of OAB drugs in order to equip clinicians with information on the drug that might best meet their patient's needs. Flexibly dosed fesoterodine appeared to be most efficacious in resolving urgency and urgency incontinence compared with other drugs, and resolution of urinary urgency appears to be associated with a reduced number of reported adverse events.

The role of novel minimally invasive treatments for lower urinary tract symptoms associated with benign prostatic hyperplasia.

OBJECTIVES: To provide an update on novel minimally invasive lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH) treatments in a non-systematic review. To define potential target populations for the various new minimally invasive treatments. METHODS: Recent literature, meta-analyses and guideline recommendations for aquablation (AquaBeam® ; PROCEPT BioRobotics, Redwood City, CA, USA), water vapour thermal therapy (Rezum® ; Boston Scientific, Natick, MA, USA), prostate artery embolisation (PAE), prostatic urethral lift (UroLift® ; NeoTract-Teleflex, Pleasanton, CA, USA) and the temporary implantable nitinol device [i-TIND® (nitinol butterfly-like stent ); Medi-Tate Ltd., Or-Akiva, Israel] were reviewed. RESULTS: Procedures that can be performed on an outpatient basis (Rezum, PAE, UroLift and i-TIND) are not an alternative for the standard patient requiring BPH surgery. Their effect on urinary flow, post-void residual urine volume or bladder outlet obstruction is less pronounced than that of transurethral resection of the prostate (TURP). Yet, these options appear to be valuable for those patients unfit for surgery, men who want to avoid medical therapy in general, or those who want to avoid sexual side-effects associated with medical therapy or standard BPH surgery (e.g. TURP). Aquablation is the first successfully operationalised robotic resection system, especially for patients with prostates >50 g. Nevertheless, long-term data are necessary for all novel, minimally invasive treatments. CONCLUSIONS: Better designed clinical trials, a clearer definition of target populations and a more realistic marketing allow a better characterisation of novel minimally invasive therapies for LUTS/BPH. It is hoped that some of these novel devices will stand the test of time, in contrast to the vast majority of their predecessors.

Impact of disease progression on individual IPSS trajectories and consequences of immediate versus delayed start of treatment in patients with moderate or severe LUTS associated with BPH.

PURPOSE: Despite superiority of tamsulosin-dutasteride combination therapy versus monotherapy for lower urinary tract symptoms due to benign prostatic hyperplasia (LUTS/BPH), patients at risk of disease progression are often initiated on α-blockers. This study evaluated the impact of initiating tamsulosin monotherapy prior to switching to tamsulosin-dutasteride combination therapy versus immediate combination therapy using a longitudinal model describing International Prostate Symptom Score (IPSS) trajectories in moderate/severe LUTS/BPH patients at risk of disease progression. METHODS: Clinical trial simulations (CTS) were performed using data from 10,238 patients from Phase III/IV dutasteride trials. The effect of varying disease progression rates was explored by comparing profiles on- and off-treatment. CTS scenarios were investigated, including a reference (immediate combination therapy) and six alternative virtual treatment arms (delayed combination therapy of 1-24 months). Clinical response (≥ 25% IPSS reduction relative to baseline) was analysed using log-rank test. Differences in IPSS relative to baseline at various on-treatment time points were assessed by t tests. RESULTS: Delayed combination therapy initiation led to significant (p < 0.01) decreases in clinical response. At month 48, clinical response rate was 79.7% versus 74.1%, 70.3% and 71.0% and IPSS was 6.3 versus 7.6, 8.1 and 8.0 (switchers from tamsulosin monotherapy after 6, 12 and 24 months, respectively) with immediate combination therapy. More patients transitioned from severe/moderate to mild severity scores by month 48. CONCLUSIONS: CTS allows systematic evaluation of immediate versus delayed combination therapy. Immediate response to α-blockers is not predictive of long-term symptom improvement. Observed IPSS differences between immediate and delayed combination therapy (6-24 months) are statistically significant.

Model-based meta-analysis of individual International Prostate Symptom Score trajectories in patients with benign prostatic hyperplasia with moderate or severe symptoms.

AIMS: International Prostate Symptom Score (IPSS) is a marker of lower urinary tract symptoms (LUTS) deterioration or improvement in benign prostate hyperplasia (BPH). Whereas changes in IPSS relative to baseline have been used as endpoints in clinical trials, little attention has been given to the time course of symptoms. The current investigation aimed to develop a drug-disease model to describe individual IPSS trajectories in moderate and severe BPH patients. METHODS: A model-based meta-analytical approach was used including data from 10 238 patients enrolled into Phase III and IV studies receiving placebo, tamsulosin, dutasteride or combination therapy over a period of up to 4 years. Model predictive performance was assessed using statistical and graphical criteria. Subsequently, simulations were performed to illustrate the implications of treatment with drugs showing symptomatic and disease-modifying properties in patients with varying disease progression rates. RESULTS: Improvement and worsening of IPSS could be characterized by a model including a sigmoid function which disentangles drug effects from placebo and varying disease progression rates on IPSS. Mean estimate (95% confidence intervals) for the disease progression rate was 0.319 (0.271-0.411) month-1 . Treatment effect on IPSS (DELTA) was found to be 0.0605, 0.0139 and 0.0310 month-1 for placebo, tamsulosin and combination therapy, respectively. In addition, it appears that individual trajectories can be clustered together into different phenotypes describing the underlying disease progression rate (i.e. slow, moderate and fast progressors). CONCLUSIONS: The availability of a drug-disease model enables the evaluation of interindividual differences in disease progression rate, deterioration of symptoms and treatment effects on LUTS/BPH.

Prevalence of female urinary incontinence in the developing world: A systematic review and meta-analysis-A Report from the Developing World Committee of the International Continence Society and Iranian Research Center for Evidence Based Medicine.

AIMS: The prevalence of urinary incontinence (UI) in the developing world varies widely. Factors influencing prevalence rates are a key area of interest, and knowledge of these would provide appropriate planning for preventive primary and secondary health care programs. The objective of this report was to synthesize the best available evidence to determine UI prevalence rates in adult women in a population setting. METHODS: A comprehensive search strategy was employed to find published and unpublished studies. Databases searched included PubMed, Embase, Scopus, Web of Science, and Google Scholar. We used the standardized Joanna Briggs Institute Meta-Analysis of Statistics, Assessment, and Review Instrument to appraise the included studies. RESULTS: In total, 54 studies with 138,722 women aged 10 to 90 years were included in this meta-analysis. Prevalence of UI ranged from 2.8% in Nigeria to 57.7% in Iran. The total prevalence of UI was 25.7% (95% CI: 22.3-29.5) and the prevalence rates for stress, urgency, and mixed UI were 12.6% (95% CI: 10.3-15.4), 5.3% (95% CI: 3.4-8.3), and 9.1% (95% CI: 7.0-11.8), respectively. When we excluded the elderly population, UI prevalence only slightly changed (26.2%; 95% CI: 22.6-30.2). Prevalence rates varied considerably during different recall periods, ranging from 15.6% for UI during the last 12 months to 41.2% for UI during the last 3 months. However, the study quality and use of validated vs nonvalidated questionnaires only had a minor impact on the prevalence rates. CONCLUSIONS: The prevalence, methodology, and definition of UI vary widely. A large-scale multinational study with a homogeneous methodology is necessary to correctly calculate and compare the prevalence rates to improve health policies in the developing world.

The International Continence Society (ICS) report on the terminology for male lower urinary tract surgery.

INTRODUCTION: In the development of terminology of the lower urinary tract (LUT), due to its increasing complexity, the terminology for male LUT surgery needs to be updated using a male-specific approach and via a clinically-based consensus report. METHODS: This report combines the input of members of the Standardization Committee of the International Continence Society in a Working Group with recognized experts in the field, assisted by many external referees. Appropriate core clinical categories and a subclassification were developed to give a numeric coding to each definition. An extensive process of 14 rounds of internal and external review was developed to exhaustively examine each definition, with decision-making by collective opinion (consensus). RESULTS: A Terminology Report for male LUT and pelvic floor surgery, encompassing 149 separate definitions/descriptors, has been developed. It is clinically-based with the most common diagnoses defined. Clarity and user-friendliness have been key aims to make it interpretable by practitioners and trainees in male LUT surgery. Figures have not been included to avoid any preference or bias towards a specific procedure. CONCLUSIONS: A consensus-based Terminology Report for male LUT surgery has been produced aimed at being a significant aid to clinical practice and a stimulus for research.

The International Continence Society (ICS) report on the terminology for adult male lower urinary tract and pelvic floor symptoms and dysfunction.

INTRODUCTION: In the development of terminology of the lower urinary tract, due to its increasing complexity, the terminology for male lower urinary tract and pelvic floor symptoms and dysfunction needs to be updated using a male-specific approach and via a clinically-based consensus report. METHODS: This report combines the input of members of the Standardisation Committee of the International Continence Society (ICS) in a Working Group with recognized experts in the field, assisted by many external referees. Appropriate core clinical categories and a subclassification were developed to give a numeric coding to each definition. An extensive process of 22 rounds of internal and external review was developed to exhaustively examine each definition, with decision-making by collective opinion (consensus). RESULTS: A Terminology Report for male lower urinary tract and pelvic floor symptoms and dysfunction, encompassing around 390 separate definitions/descriptors, has been developed. It is clinically-based with the most common diagnoses defined. Clarity and user-friendliness have been key aims to make it interpretable by practitioners and trainees in all the different specialty groups involved in male lower urinary tract and pelvic floor dysfunction. Male-specific imaging (ultrasound, radiology, CT, and MRI) has been a major addition whilst appropriate figures have been included to supplement and help clarify the text. CONCLUSIONS: A consensus-based Terminology Report for male lower urinary tract and pelvic floor symptoms and dysfunction has been produced aimed at being a significant aid to clinical practice and a stimulus for research.

The development of the ICIQ-UAB: A patient reported outcome measure for underactive bladder.

AIMS: To present the development of the International Consultation on Incontinence Questionnaire-underactive bladder (ICIQ-UAB) as the first patient reported outcome measure for the assessment of the symptoms and impact on the health-related quality of life of UAB developed in-line with the Food and Drug Administration Guidance for Industry. METHODS: Draft items were developed following 44 semi-structured concept elicitation interviews in the UK and refined using 36 cognitive interviews. A pilot study was designed to assess the draft ICIQ-UAB's initial psychometric properties with 54 patients recruited from European hospitals. Further concept elicitation interviews were also carried out with 11 patients in the US and 10 patients in Japan. All participants had a prior urodynamic diagnosis of detrusor underactivity. RESULTS: The cognitive interviews confirmed the initial items to be understood and interpreted as intended. Pilot testing showed that both internal consistency (Cronbach's α ≥ 0.85) and test-retest reliability (stable patients; intraclass correlation coefficient ≥ 0.88) were high. The interviews in the US and Japan elicited symptoms and impacts that support previous findings in the UK and provided further insight into the experiences of patients in those countries. The developmental ICIQ-UAB was refined using the evidence from all substudies. CONCLUSIONS: The validity and reliability of the ICIQ-UAB were supported in a pilot study setting and the wider cultural applicability by the additional interviews in the US and Japan. Following further validation in future clinical trials, the developmental ICIQ-UAB is envisaged as an important tool for the monitoring of future UAB treatment strategies.

Do patient characteristics predict which patients with overactive bladder benefit from a higher fesoterodine dose?

INTRODUCTION AND HYPOTHESIS: We sought to determine whether baseline characteristics predict which overactive bladder (OAB) patients benefit from fesoterodine 8 mg versus 4 mg. METHODS: In double-blind, placebo-controlled, flexible-dose trials, baseline characteristics of OAB patients with ≥ 1 urgency urinary incontinence (UUI) episodes/24 h who escalated from fesoterodine 4 mg to 8 mg were evaluated. Possible dose-escalation predictors (age; sex; previous antimuscarinic use; UUI, micturitions, and urgency episodes/24 h; race; body mass index; time to dose escalation; OAB duration) were compared in escalators versus non-escalators. Patients from fixed-dose trials with dose-escalator characteristics were identified (matched dose-escalator sample) to assess changes from baseline with fesoterodine 4 mg, 8 mg, and placebo. RESULTS: In flexible-dose trials, significant predictors of fesoterodine dose escalation were younger age (≤ 65.8 years), greater number of baseline micturitions (≥ 13.1) and urgency episodes/24 h (≥ 10.9), greater OAB duration (≥ 9.1 years), and more frequent previous antimuscarinic use (58.3%), but not baseline UUI episodes/24 h. In the matched dose-escalator sample (fesoterodine 4 mg: n = 215; 8 mg: n = 198; placebo: n = 217), change from baseline in UUI episodes significantly improved with fesoterodine 8 mg versus 4 mg (P = 0.043) and with both doses versus placebo (P < 0.001). Dry mouth and constipation rates were higher with fesoterodine 8 mg. CONCLUSIONS: Dose-escalator patients had a significantly greater UUI response with fesoterodine 8 mg versus 4 mg. Given the potential for adverse events, fesoterodine 4 mg is recommended to start; however, patients with UUI and identified predictors may benefit from initial treatment with fesoterodine 8 mg or rapid dose escalation.

Development and validation of a patient decision aid for prostate Cancer therapy: from paternalistic towards participative shared decision making.

BACKGROUND: Patient decision aids (PDAs) can support the treatment decision making process and empower patients to take a proactive role in their treatment pathway while using a shared decision-making (SDM) approach making participatory medicine possible. The aim of this study was to develop a PDA for prostate cancer that is accurate and user-friendly. METHODS: We followed a user-centered design process consisting of five rounds of semi-structured interviews and usability surveys with topics such as informational/decisional needs of users and requirements for PDAs. Our user-base consisted of 8 urologists, 4 radiation oncologists, 2 oncology nurses, 8 general practitioners, 19 former prostate cancer patients, 4 usability experts and 11 healthy volunteers. RESULTS: Informational needs for patients centered on three key factors: treatment experience, post-treatment quality of life, and the impact of side effects. Patients and clinicians valued a PDA that presents balanced information on these factors through simple understandable language and visual aids. Usability questionnaires revealed that patients were more satisfied overall with the PDA than clinicians; however, both groups had concerns that the PDA might lengthen consultation times (42 and 41%, respectively). The PDA is accessible on http://beslissamen.nl/ . CONCLUSIONS: User-centered design provided valuable insights into PDA requirements but challenges in integrating diverse perspectives as clinicians focus on clinical outcomes while patients also consider quality of life. Nevertheless, it is crucial to involve a broad base of clinical users in order to better understand the decision-making process and to develop a PDA that is accurate, usable, and acceptable.