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Resume Objectifs Le seul systeme actuellement disponible pour le traitement de l’hyperactivite vesicale idiopathique (HAVI) refractaire par neuromodulation des racines sacrees (NMS) presente une batterie non rechargeable d’une duree de 3 a 6 ans, pouvant necessiter plusieurs chirurgies pour remplacement. L’objectif de l’etude RELAX-OAB etait d’evaluer la securite et l’efficacite d’un nouveau systeme de NMS rechargeable d’une duree de 15 ans ayant recu le marquage ce en 2016. Methodes Etude prospective multicentrique incluant les patients presentant un diagnostic d’HAVI refractaire eligible a la NMS entre juin 2016 et fevrier 2017. L’electrode et le stimulateur ont ete implantes en une seule procedure, sans test externe. Le premier mois suivant l’implant a servi de phase de test. Un calendrier mictionnel sur 3 jours, des questionnaires de qualite de vie specifiques (ICIQ-OAB QOL) et de satisfaction ont ete collectes a 1, 3, 6 et 12 mois. Les patients repondeurs etaient definis ainsi : reduction ≥ 50 % du nombre de miction par 24 h, du nombre de fuites par 24 h ou moins de 8 mictions par jour. Resultats Soixante et onze pour cent des 51 patients implantes etaient repondeurs a l’issue du mois de test. Apres 12 mois, 94 % des patients repondeurs au test continuaient de repondre au traitement. Les patients presentaient une reduction moyenne de 69 % de leurs fuites quotidiennes (p Conclusion Ces resultats confirment l’efficacite et la securite a moyen terme du premier systeme de NMS rechargeable. Ce systeme permet une nouvelle offre de soin, avec le potentiel d’ameliorer de maniere significative le profil economique et la balance benefice–risque de la therapie par NMS, par rapport a un produit non rechargeable.

Objectifs La neuromodulation sacree (NMS) est un traitement symptomatique recommande pour le syndrome d’hyperactivite vesicale (HAV). Actuellement, les NMS implantees sont non rechargeables avec une duree de vie de 3 a 5 ans. Le systeme Axonics® (r-NMS), approuve en 2016, est rechargeable avec une duree de vie de 15 ans. L’objectif de cette etude est d’evaluer la securite et l’efficacite de ce systeme. Methodes Il s’agit d’une etude clinique prospective multicentrique, simple bras. Les patients concernes presentaient un diagnostic d’hyperactivite vesicale idiopathique. Les criteres de jugements etaient les symptomes d’HAV sur le calendrier mictionnel, les reponses au questionnaire de qualite de vie specifique valide (ICIQ OAB QoL) et la satisfaction du patient a 1 et 3 mois. Les patients etaient systematiquement implantes avec le boitier de neuromodulation Axonics (R), dont la taille est tres petite, sans phase de test. Resultats Cinquante et un patients ont ete inclus dans 7 centres. A 3 mois, le taux d’efficacite sur la reduction des symptomes d’HAV sur le calendrier mictionnel etait de 73 % des patients a 3 mois (n = 33). Il a ete observe une reduction significative du nombre de mictions et de fuites urinaires quotidiennes (p Figure 1 , Figure 2 , Tableau 1 ). Conclusion Le systeme r-NMS semble etre sur et efficace a 3 mois de l’implantation. Les patients peuvent recharger le systeme et aucun evenement indesirable concernant le chargement n’a ete reporte. L’interet du systeme rechargeable est double, au niveau medicoeconomique ainsi que pour le patient en permettant de limiter la repetition des interventions chirurgicales.

Introduction To examine pooled efficacy data from three, large phase III studies comparing mirabegron (50 and 100 mg) with placebo, and pooled safety data including additional mirabegron 25 mg and tolterodine extended release (ER) 4 mg results. Methods This prespecified pooled analysis of three randomised, double‐blind, placebo‐controlled, 12‐week studies, evaluated efficacy and safety of once‐daily mirabegron 25 mg (safety analysis), 50 or 100 mg (efficacy and safety analyses) and tolterodine ER 4 mg (safety analysis) for the treatment of symptoms of overactive bladder (OAB). Co‐primary efficacy measures were change from baseline to Final Visit in the mean number of incontinence episodes/24 h and mean number of micturitions/24 h. Key secondary efficacy end‐points included mean number of urgency episodes/24 h and mean volume voided/micturitions, while other end‐points included patient‐reported outcomes according to the Treatment Satisfaction‐Visual Analogue Scale (TS‐VAS) and responder analyses [dry rate (posttreatment), ≥ 50% reduction in incontinence episodes/24 h, ≤ 8 micturitions/24 h (post hoc analysis)]. The safety analysis included adverse event (AE) reporting, laboratory assessments, ECG, postvoid residual volume and vital signs (blood pressure, pulse rate). Results Mirabegron (50 and 100 mg once daily) demonstrated statistically significant improvements compared with placebo for the co‐primary end‐points, key secondary efficacy variables, TS‐VAS and responder analyses (all comparisons p < 0.05). Mirabegron is well tolerated and demonstrates a good safety profile. The most common AEs (≥ 3%) included hypertension, nasopharyngitis and urinary tract infection (UTI); the incidence of hypertensive events and UTIs decreased with increasing dose. For mirabegron, the incidence of the bothersome antimuscarinic AE, dry mouth, was at placebo level and of a lesser magnitude than tolterodine. Conclusion The efficacy and safety of mirabegron are demonstrated in this large pooled clinical trial dataset in patients with OAB.

Several electrical stimulation techniques are available for the treatment of the underactive bladder (uab). The techniques available are applicable for different neurogenic situations such as the anterior sacral root stimulation after selective posterior sacral rhizotomy (the brindley technique) in patients with a complete spinal cord injury and preserved contractility of the detrusor. Sacral neuromodulation is clinically available and fda approved for patients with underactive bladder. Transurethral electrotherapy is attractive minimally invasive option, but further clinical studies are required to establish efficacy. In this chapter we discuss various treatment techniques, indications and their outcomes in the context of detrusor underactivity/uab.keywordselectrical stimulationneuomodulationdetrusor underactivityunderactive bladder.

Purpose: Chronic pelvic pain syndrome is a debilitating disease which often has a major impact on quality of life. A significant number of patients do not respond to conservative treatment and often no good alternative can be offered except radical surgery. Sacral neuromodulation is a well established therapy for patients with lower urinary tract dysfunction. This therapy has also been suggested to be useful in the treatment of chronic pelvic pain. Although currently no Food and Drug Administration approval exists for this indication, several studies have demonstrated promising results. We provide an overview of the published literature on sacral neuromodulation as a treatment for chronic pelvic pain. Materials and Methods: A PubMed (R) search was performed to identify articles in English from 1990 to February 2010 reporting treatment of pelvic pain with sacral neuromodulation. In addition, the current definitions of pelvic pain syndromes and the mechanisms of action are discussed. Results: A total of 12 relevant articles were identified. Of these articles 10 mainly addressed the efficacy of sacral neuromodulation in patients with interstitial cystitis/bladder pain. The percentage of patients who responded to test stimulation was reported between 51% and 77%. Of the 10 articles 7 reported treatment outcome after implantation. The duration of followup ranged between 5 and 87 months. The mean reduction in pain scores was reported between 40% and 72%. The reoperation rate ranged between 27% and 50% after long-term followup. Two articles included patients with miscellaneous urogenital pain syndromes. The success rates after implantation ranged from 60% to 77% with followup ranging between 19 and 36 months. Conclusions: Currently there is insufficient evidence to determine the role of sacral neuromodulation in the treatment of chronic pelvic pain. Larger prospective trials with long-term evaluation are required to determine the ultimate efficacy of this treatment.

Nocturia is a bothersome and highly prevalent urological condition characterised by the need to wake to void at night. Contrary to popular misconception, nocturia is equally common in men and women, and although its prevalence increases with age, a significant proportion of younger people are also affected. Nocturia leads to repeated fragmentation of sleep and consequently to a serious decline in daytime functioning and in overall quality of life and health. As such, its impact should not be underestimated by clinicians. Traditionally, nocturia has been regarded as a symptom of benign prostatic enlargement and/or overactive bladder syndrome, with treatment therefore directed towards increasing the capacity of the bladder to hold urine. Such treatments have proven largely ineffective in many patients, likely because nocturnal polyuria (NP), a condition that results in overproduction of urine at night, has been found to be present in the majority of nocturia patients. As such, the traditional belief that nocturia is attributable to some other underlying pathological factors, is now being replaced by the acknowledgment that it can be a distinct clinical entity with specific pathogenesis. Frequency-volume charts are an invaluable tool, recommended for routine use in clinical practice, to determine whether nocturia is a result of excessive urine production at night, or of small voided volumes ( indicating bladder storage problems), or indeed a combination of these factors. Given the specific antidiuretic action of desmopressin, a synthetic analogue of the body's own antidiuretic hormone, it should be considered as first-line therapy for patients with nocturia where NP is present.

Aims To determine (using structured brain storm sessions), which treatments should be used if drugs fail for OAB and to determine priority research questions in relation to this issue. Methods A frame work for discussion was prepared by the chairman of the session; this included a brief summary of the currently existing evidence. Several experts had been asked to prepare a presention of their personal treatment algorithm and to identify the [lack of] evidence for such an algorithm. These presentations were summarized by the chairman. Next, this summary was discussed with a large group of experts and opinion leaders and audio-recorded. The proceedings of this process are the basis for this manuscript. Results The structured sessions resulted in detailed statements about: possible reasons for failure of conservative treatment, the evaluation of outcomes of RCT's, the use of botulinum toxin A in refractory OAB patients, the relative place of neuromodulation or sacral nerve stimulation and botulinum toxin A in the treatment of refractory OAB. Conclusions A list of 10 unanswered questions and research topics was compiled. Additionally, 5 top priority research topics were identified. Neurourol. Urodynam. 29:658–661, 2010. Copyright © 2010 Wiley-Liss, Inc.

The overactive bladder syndrome (OAB) negatively affects the daily life of many people worldwide and conservative treatments, such as antimuscarinics, not always bring relief and/or are associated with considerable side effects resulting in treatment failure. Second line treatment options used to be invasive surgical procedures. However, less radical, minimally invasive and reversible alternatives, such as sacral neuromodulation and botulinum toxin A have emerged. Of these, only sacral neuromodulation with InterStim Therapy has been approved for OAB and been recommended by the International Consultation on Incontinence (ICI) in 2004. Nevertheless, depending of country rules and habits, both seem to be used by urologists in clinical practice for treating idiopathic OAB (I OAB). Therefore, this review attempts to provide an update on the available clinical evidence concerning the efficacy and safety, and the current position of sacral neuromodulation and botulinum toxin A in the second line management of adults with I OAB.

Guidelines for the management of continence and overactive bladder are generally available across Europe. For a majority of countries, these have been adopted by professional societies in either urology or gynaecology for local use. There has, however, been little monitoring of formal implementation of these guidelines and seldom any attempt to audit their operation. The state of continence care therefore remains largely unknown. This article reviews current guidelines and their status across Europe and examines what might be relevant from other disease areas to promote successful implementation.

Localized phasic contractions in the bladder wall (autonomous activity) have been hypothesized to be an integral part of a motor/sensory system contributing to bladder sensation. The sites responsible for generating this activity, the mechanisms involved in its propagation and modulation remain unknown. This phasic motor activity is modulated by exogenous prostaglandins. Therefore, analysis of the sites of prostaglandin production and action within the bladder wall may shed light on the mechanisms of generation and modulation of this phasic activity. In this paper we report the localization of immuno-reactivity indicative of the expression of cyclo-oxygenase enzyme type I (COX I-IR) within the bladder wall. Basically, three types of COX I-IR cell were identified: epithelial cells in the basal and intermediate layers of the urothelium, complex vimentin-positive and COX I-IR cells in the lamina propria and vimentin-negative COX I-IR cells in the lamina propria and on the surface of the inner muscle bundles. These vimentin-negative/COX I-IR cells appear to be in close apposition to a continuous network of vimentin-positive cells, which extends from the lamina propria into the inner muscle layers and subsequently into the outer muscle layers. However, the interstitial cells in this region might form a distinctly different sub-type. First, the interstitial cells in this region differ from those in the inner layer by their responsiveness to NO with a rise in cGMP. Two subtypes have been identified: cells on the surface of the muscle bundles and within the muscle bundles. Second, COX I-IR cells are not associated with the interstitial cells in the outer layers. The physiological significance for these apparent differences in the interstitial cell network is not clear. However, such differences are likely to reflect differences in the processes involved in their activation, modulation and control.

Overactive bladder (OAB) affects an estimated 49 million people in Europe, but only a minority receive appropriate treatment. Others are bothered by unacceptable levels of symptoms that severely impair their quality of life and represent a significant financial burden to themselves and to their healthcare providers. Recently updated guidelines from the International Consultation on Incontinence (ICI) and the European Association of Urology (EAU) take account of important new developments in the management of bladder problems in both primary and secondary care. However, local implementation of previous guidance has been variable, with many patients with OAB and other bladder problems failing to gain full benefit from current clinical and scientific understanding of these conditions. The recent expansion of the range of treatments available for OAB and stress urinary incontinence makes it especially important that physicians become aware of the differential diagnosis of these conditions - the questions they need to ask, and the investigations which will help determine the most appropriate course of action.

Purpose: To our knowledge we report the first long-term use of desmopressin for nocturia. Patients previously responding to desmopressin in short-term studies were enrolled in this long-term open label study. Materials and Methods: Patients received treatment for 10 or 12 months with the optimal desmopressin dose (0.1, 0.2 or 0.4 mg orally at bedtime). Patients were followed a further month without treatment. Of the patients completing the short-term study 132 males (92%) and 117 females (83%) were recruited, and 95 (72%) and 87 (75%), respectively, completed long-term treatment. Results: The mean number of nocturnal voids was decreased in males and females throughout the study (1.3 to 1.6 and 1.2 to 1.3) compared with baseline (3.1 and 2.9, respectively). After followup the number of voids increased after treatment cessation. From baseline to 12 months the mean duration of the first sleep period gradually increased in males (157 to 288 minutes) and females (142 to 310 minutes). After followup the mean duration of the first sleep period decreased, confirming that it was a treatment related benefit. Desmopressin was well tolerated with few males (14%) or females (10%) withdrawing due to adverse events. Most adverse events were mild (44%) or moderate (44%) in severity. Four males experienced serious drug related adverse events, namely dizziness in 1, cardiac failure, headache and vomiting in 2, and chest pain and hypertension in 1. A female experienced 4 serious drug related adverse events, that is hyponatremia, headache, nausea and vertigo. Two patients had clinically significant hyponatremia. Conclusions: This long-term study shows that desmopressin is a generally well tolerated and effective treatment for nocturia.

OBJECTIVES To examine the efficacy and safety of a once-daily formulation of alfuzosin in a pooled analysis of three parallel, randomized, double-blind, placebo-controlled 3-month studies of patients with lower urinary tract symptoms (LUTS) consistent with clinical benign prostatic hyperplasia. PATIENTS AND METHODS Patients were randomized to receive alfuzosin, 10 mg once-daily (473) or placebo (482) for 12 weeks. Primary efficacy criteria were improvements in the International Prostate Symptom Score (IPSS) and peak urinary flow rate (PFR). RESULTS Alfuzosin significantly improved the mean (sd) IPSS, by − 6.0 (5.1) vs − 4.2 (5.7) with placebo (P

OBJECTIVE To examine the benefit-risk profile of neuromodulation in treating refractory urinary urge incontinence and other voiding disorders. PATIENTS AND METHODS The outcome measures from all patients in pivotal clinical trials who had undergone sacral nerve stimulation were analysed retrospectively. RESULTS Neuromodulation was effective in several clinical studies; the response is durable and the benefit-risk profile good. CONCLUSION Sacral nerve stimulation is becoming the standard of care for refractory overactive bladder and retention problems. The potential benefit of neuromodulation should be included in female urology and gynaecology training programmes.

OBJECTIVE: To investigate the efficacy and safety of oral desmopressin in the treatment of nocturia in men. PATIENTS AND METHODS: Men aged >/=18 years with verified nocturia (>or=two voids/night) and nocturnal urine production greater than their maximum functional bladder capacity were recruited. A 3-week dose-titration phase established the optimum desmopressin dose (0.1, 0.2 or 0.4 mg). After a 1-week 'washout' period, patients who responded in the dose-titration period were randomized to receive the optimal dose of desmopressin or placebo in a double-blind design for 3 weeks. RESULTS: In all, 151 patients entered the double-blind period (86 treated with desmopressin, 65 with placebo). In the desmopressin group 28 (34%) patients and in the placebo group two (3%) patients (P

To assess the long-term efficacy and safety of alfuzosin 10 mg OD in patients with symptomatic BPH.Patients (50 years) were randomised to alfuzosin 10 mg OD, alfuzosin 2.5. mg t.i.d. or placebo for 3 months. Open-label alfuzosin 10 mg OD was continued for up to 1 year. Efficacy assessments included the International Prostate Symptom Score (I-PSS) and quality of life index and uroflowmetry.At 3 months, there was a significant reduction in I-PSS and a significant improvement in peak flow rate for both alfuzosin groups compared with placebo (p0.05). Vasodilatory adverse experiences were more common in the alfuzosin 2.5 mg group than the 10 mg OD group. Improvements in symptoms and flow rate with alfuzosin 10 mg OD were maintained for up to 12 months.Alfuzosin 10 mg OD is an effective treatment for symptomatic BPH for at least 12 months, with a better cardiovascular safety profile than the immediate release formulation.

To assess the efficacy and safety of a new prolonged release formulation of the uroselective alpha(1)-blocker alfuzosin for a once-daily dosing regimen in patients with lower urinary tract symptoms (LUTS) suggestive of symptomatic benign prostatic hyperplasia (BPH).After a 1-month run-in period, 447 patients were randomly allocated in a double-blind placebo-controlled study to receive alfuzosin 10 mg once daily (n = 143), alfuzosin 2.5 mg thrice daily (n = 150) or placebo (n = 154) for 3 months. At inclusion, 46% of the randomised population had concomitant cardiovascular disease and 30% received an antihypertensive treatment. Uroflowmetry was performed close to trough plasma concentration of alfuzosin once daily to demonstrate the 24-hour coverage with this formulation.Both alfuzosin formulations significantly improved urinary symptoms versus placebo assessed using the International Prostate Symptom Score (alfuzosin 10 mg once daily: -6.9; alfuzosin 2.5 mg thrice daily: -6.4; placebo: -4.9, p = 0.005). Peak flow rate increased significantly with alfuzosin 10 mg once daily (+2.3 ml/s, p = 0.03 vs. placebo) and with alfuzosin 2.5 mg thrice daily (+3.2ml/s, p0.0001 vs. placebo) compared to placebo (+1.4 ml/s). Overall both formulations of alfuzosin were well tolerated in comparison with placebo. In addition, vasodilatory adverse events appeared to be less frequent with the once daily than the thrice daily formulation (6.3 vs. 9.4%, respectively). No first-day effect was reported with alfuzosin once daily and the effect on blood pressure did not differ from those observed in placebo, both in normotensive and hypertensive patients. No specific sexual dysfunction including ejaculation disorder was reported in the alfuzosin 10 mg once-daily group.The new once-daily formulation of alfuzosin administered at a dose of 10 mg daily is an effective 24-hour treatment of LUTS associated with BPH. Alfuzosin is as effective as the immediate formulation and shows a better cardiovascular safety. The better safety profile enables the same dose to be used in all patients, providing the patients with the benefits of a once-daily administration.

The aim of this study was to determine the long-term clinical efficacy and complications of neuromodulation with a unilateral sacral foramen electrode in 36 patients with chronic voiding dysfunction. Following a positive effect of a percutaneous nerve evaluation test, patients underwent open surgery. A permanent electrode was implanted in 24 patients with urge incontinence, in 6 with urgency-frequency syndrome, and in 6 with nonobstructive urinary retention. After an average follow-up period of 37.8 months, 19 patients (52.8%) continue to benefit from the neuromodulation with a significant improvement of symptoms and urodynamic parameters. The median duration of the therapeutic effect for the total study population was longer than 60 months. No significant difference in the median duration of therapeutic effect with regard to sex, the type of voiding disorder, or the implant pulse generator was found. However, in patients with previous psychological disorders the median duration of therapeutic effect was only 12 months (P = 0.008). Complications were mild. In the group of patients in whom the therapeutic effect remains, 37 reoperations have had to be performed. We conclude that although reoperations were needed to overcome technical problems, patients can achieve lasting symptomatic improvement. Since technical changes in the equipment have reduced the number of complications, even better results can be expected in terms of the reoperation rate.