Salvage perineal-retropubic AUS cuff in paraplegic patient with exstrophy-epispadias complex after previous cuff erosion at bladder neck.

Cuff erosion at the bladder neck of an implanted artificial urinary sphincter (AUS) needs complete explantation of the device. The subsequent scar tissues predispose to repeated cuff erosion, when another AUS is implanted with the cuff at a similar location. We describe a paraplegic patient with exstrophy-epispadias complex that suffered from an AUS cuff erosion at the bladder neck. We use a novel perineal-retropubic route for cuff placement, with preparation similar to a retropubic male sling. At 12 years follow-up the AUS is still functional and the patient continent.

Efficacy and safety of mirabegron for the treatment of low compliance bladder resulting from sacral/infrasacral lesions: A prospective study.

OBJECTIVE: To assess the efficacy and safety of mirabegron in patients with sacral/infrasacral lesions who have an acontractile detrusor and develop a low compliance bladder. METHODS: This prospective study included adult patients with acontractile detrusor as a result of sacral/infrasacral lesions who develop a low compliance bladder (compliance <20 mL/cmH2 O). All patients were asked to make a 48-h clean intermittent catheterization diary and underwent invasive urodynamics evaluation at the baseline, and were started on mirabegron 50 mg once daily. Patients were re-evaluated at 6 weeks with a repeat clean intermittent catheterization diary and invasive urodynamics, and the efficacy and safety of mirabegron was assessed. RESULTS: A total of 17 patients were included. After 6 weeks of mirabegron therapy, the number of patients reporting leakage in between clean intermittent catheterization reduced from seven to two (P = 0.02), the end filling pressures reduced from 41.4 to 15.1 cmH2 O (P = 0.003), the compliance increased from 9.8 to 99.9 mL/cmH2 O (P = 0.000), and the number of patients where the end filling pressure was >40 cmH2 O reduced from eight to one (P = 0.02). The cystometric bladder capacity did not change significantly. Similar effects were noted in patients who were already on clean intermittent catheterization or were started on clean intermittent catheterization at inclusion in the study. Mirabegron was well tolerated, none of the patients discontinued therapy or reported major side-effects. CONCLUSIONS: Mirabegron reduces end filling pressure, improves compliance and is safe in patients with a low compliance bladder resulting from a sacral/infrasacral lesion.

Work-up for the neurourological patient.

A targeted history and physical examination are the mainstays for basic evaluation of neurourological patients. Urodynamics investigations are of paramount importance in providing information about the pressure situation in the lower urinary tract (LUT). Pressures are crucial not only for LUT but also for upper urinary tract function. Regular ultrasound assessment is advisable but cannot replace invasive urodynamics.

Frequency volume chart for the illiterate population: A simple solution.

INTRODUCTION: We aimed to assess the feasibility of a novel method of recording frequency volume chart (FVC) in adult patients who are either illiterate or are unable to make the required written record. MATERIALS AND METHODS: This prospective study included adult patients, in whom FVC was required as part of their urological evaluation, who were either illiterate or were not sufficiently literate to make the required written record. Three groups of people were involved in the study: (i) patient, (ii) nursing staff, and (iii) the investigator/coinvestigator. The investigator/coinvestigator briefed the patient and the nursing staff, separately, regarding their roles in detail. The patient-reported (investigator/coinvestigator interpreted) data were compared with the data recorded by the nursing staff to assess the feasibility of this novel method. RESULTS: A total of 30 patients were included in the study, with a mean age of 45.1 years and male: female ratio of 2:1. The patient-reported (investigator/coinvestigator interpreted) data including 24-h urine production, daytime urine volume, nocturnal urine volume, daytime urinary frequency, nocturia, average voided volume, and maximum voided volume were similar to the data reported by the nursing staff, with no significant differences. All patients completed the FVC satisfactorily, except one patient who failed to report the night time voids. CONCLUSIONS: Our novel method of recording FVC is feasible, reliable, and clinically as informative/applicable as the written FVC in patients who are illiterate/insufficiently literate to make a written record of FVC.

Gains in health utility associated with urinary catheter innovations.

PURPOSE: To estimate gains in health utility for two different catheter features and a support service related to urinary catheters used for intermittent catheterization. PATIENTS AND METHODS: Two internet-based time trade-off (TTO) surveys were undertaken to value vignettes describing two innovative catheter features and a support service. The first TTO survey "Size and Service" included catheters with compact design and the availability of a support service for users; the second TTO survey "Phthalates" included avoidance of potentially harmful phthalates in the material of the catheters. All participants were from the UK; they traded health states against a time horizon that matched their total life expectancy. Sensitivity analyses were done to estimate the impact of extreme values on disutilities. RESULTS: The participants (n=890) estimated the incremental value of 0.031 (95% CI: 0.024-0.039), 0.009 (95% CI: 0.003-0.015), and 0.037 (95% CI: 0.027-0.046), respectively, for catheters with compact design, availability of support service, and catheters not containing phthalates. CONCLUSIONS: Participants valued all three improvements in catheter design. To capture the impact of such design improvements on quality of life and utilities, vignette-based approaches can be a useful supplement to the conventional, generic tools.

The impact of different scenarios for intermittent bladder catheterization on health state utilities: results from an internet-based time trade-off survey.

AIMS: Intermittent catheterization (IC) is the gold standard for bladder management in patients with chronic urinary retention. Despite its medical benefits, IC users experience a negative impact on their quality of life (QoL). For health economics based decision making, this impact is normally measured using generic QoL measures (such as EQ-5D) that estimate a single utility score which can be used to calculate quality-adjusted life years (QALYs). But these generic measures may not be sensitive to all relevant aspects of QoL affected by intermittent catheters. This study used alternative methods to estimate the health state utilities associated with different scenarios: using a multiple-use catheter, one-time-use catheter, pre-lubricated one-time-use catheter and pre-lubricated one-time-use catheter with one less urinary tract infection (UTI) per year. METHODS: Health state utilities were elicited through an internet-based time trade-off (TTO) survey in adult volunteers representing the general population in Canada and the UK. Health states were developed to represent the catheters based on the following four attributes: steps and time needed for IC process, pain and the frequency of UTIs. RESULTS: The survey was completed by 956 respondents. One-time-use catheters, pre-lubricated one-time-use catheters and ready-to-use catheters were preferred to multiple-use catheters. The utility gains were associated with the following features: one time use (Canada: +0.013, UK: +0.021), ready to use (all: +0.017) and one less UTI/year (all: +0.011). LIMITATIONS: Internet-based survey responders may have valued health states differently from the rest of the population: this might be a source of bias. CONCLUSION: Steps and time needed for the IC process, pain related to IC and the frequency of UTIs have a significant impact on IC related utilities. These values could be incorporated into a cost utility analysis.

Neurogenic bowel dysfunction: Clinical management recommendations of the Neurologic Incontinence Committee of the Fifth International Consultation on Incontinence 2013.

BACKGROUND: Evidence-based guidelines for the management of neurological disease and lower bowel dysfunction have been produced by the International Consultations on Incontinence (ICI). These are comprehensive guidelines, and were developed to have world-wide relevance. AIMS: To update clinical management of neurogenic bowel dysfunction from the recommendations of the 4th ICI, 2009. MATERIALS AND METHODS: A series of evidence reviews and updates were performed by members of the working group. The resulting guidelines were presented at the 2012 meeting of the European Association of Urology for consultation, and modifications applied to deliver evidence based conclusions and recommendations for the scientific report of the 5th edition of the ICI in 2013. RESULTS: The current review is a synthesis of the conclusions and recommendations, including the algorithms for initial and specialized management of neurogenic bowel dysfunction. The pathophysiology is described in terms of spinal cord injury, multiple sclerosis, and Parkinson's disease. Assessment requires detailed history and clinical assessment, general investigations, and specialized testing, if required. Treatment primarily focuses on optimizing stool consistency and regulating bowel evacuation to improve quality of life. Symptom management covers conservative and interventional measures to promote good habits and assist stool evacuation, along with prevention of incontinence. Education is essential to achieving optimal bowel management. DISCUSSION: The review offers a pragmatic approach to management in the context of complex pathophysiology and varied evidence base.

Results of a randomized, double-blind, active-controlled clinical trial with propiverine extended release 30 mg in patients with overactive bladder.

OBJECTIVE: To compare the efficacy and safety of the 30 mg extended release (ER) formulation of propiverine hydrochloride with the 4 mg ER formulation of tolterodine tartrate in patients with overactive bladder (OAB) in a non-inferiority trial. PATIENTS AND METHODS: Eligible patients, aged 18-75 years and with symptoms of OAB, were enrolled in this multicentre, randomized, double-blind, parallel-group, active-controlled study. After a 2-week screening period, patients were randomized at a 1:1 ratio to receive either propiverine ER 30 mg or tolterodine ER 4 mg daily during the 8-week treatment period. Efficacy was assessed using a 3-day voiding diary and patient's self-reported assessment of treatment effect. Safety assessment included recording of adverse events, laboratory test results, measurement of post-void residual urine and electrocardiograms. RESULTS: A total of 324 patients (244 female and 80 male) were included in the study. Both active treatments improved the variables included in the voiding diary and in the patient's self-reported assessment. The change from baseline in the number of voidings per 24 h was significantly greater in the propiverine ER 30 mg group compared with the tolterodine ER 4 mg group after 8 weeks of treatment (full analysis set [FAS] -4.6 ± 4.1 vs -3.8 ± 5.1; P = 0.005). Significant improvements were also observed for the change of urgency incontinence episodes after 2 weeks (P = 0.026) and 8 weeks (P = 0.028) of treatment when comparing propiverine ER 30 mg with tolterodine ER 4 mg. Both treatments were well tolerated, with a similar frequency of adverse drug reactions in both the propiverine ER 30 mg and tolterodine ER 4 mg groups (FAS 40.7 vs 39.5%; P = 0.8). More patients treated with tolterodine ER 4 mg discontinued the treatment because of adverse drug reactions compared with propiverine ER 30 mg (7.4 vs 3.1%). CONCLUSIONS: Propiverine ER 30 mg was confirmed to be an effective and well-tolerated treatment option for patients with OAB symptoms. This first head-to-head study showed non-inferiority of propiverine ER 30 mg compared with tolterodine ER 4 mg.

Management of LUTS in patients with dementia and associated disorders .

AIMS: To systematically review the management of lower urinary tract symptoms (LUTS) in patients with dementia and associated disorders. METHODS: This systematic review was performed according to the PRISMA statement. Studies were identified by electronic search of Embase and Medline databases (last search August 2015) and by screening of reference lists and reviews. RESULTS: Of 1,426 abstracts that were screened, 102 full-text articles were identified and assessed for eligibility. Seventy-six articles were then included in the quantitative synthesis. Urinary incontinence (UI) prevalence rates in dementia patients have varied considerably, ranging from 11 to 93%. In Alzheimer's disease patients, UI usually correlates with disease progression (late-stage dementia). In contrast, LUTS usually precede severe mental failure in Lewy body disease and in vascular dementia. Behavioral therapy, including toilet training and prompted voiding, may be especially useful in patients with unawareness UI. High-quality data to guide the choice of treatment strategies in this population are lacking. Current evidence suggests that antimuscarinics, especially oxybutynin, can be associated with cognitive worsening, due to the blockade of M1 receptors. Thus, the use of antimuscarinics that do not easily cross the blood-brain barrier or are more M2/M3 selective should be considered. No data are available for beta-3 agonists so far. CONCLUSION: Different types of dementia cause different LUTS at varying time points during the disease process and need singular therapeutic approaches. Treatment of LUTS should be tailored to individual patient needs and disease status, considering factors like mobility, cognitive function, and general medical condition. Neurourol. Urodynam. 36:245-252, 2017. © 2015 Wiley Periodicals, Inc.

Neurogenic lower urinary tract dysfunction: Clinical management recommendations of the Neurologic Incontinence committee of the fifth International Consultation on Incontinence 2013.

BACKGROUND: Evidence-based guidelines for the management of neurological disease and lower urinary tract dysfunction have been produced by the International Consultations on Incontinence (ICI). These are comprehensive guidelines, and were developed to have world-wide relevance. AIMS: To update clinical management of neurogenic bladder dysfunction from the recommendations of the fourth ICI, 2009. MATERIALS AND METHODS: A series of evidence reviews and updates were performed by members of the working group. The resulting guidelines were presented at the 2012 meeting of the European Association of Urology for consultation, and consequently amended to deliver evidence-based conclusions and recommendations in 2013. RESULTS: The current review is a synthesis of the conclusions and recommendations, including the algorithms for initial and specialized management of neurogenic lower urinary tract dysfunction. The pathophysiology is categorized according to the nature of onset of neurological disease and the part(s) of the nervous system affected. Assessment requires clinical evaluation, general investigations, and specialized testing. Treatment primarily focuses on ensuring safety of the patient and optimizing quality of life. Symptom management covers conservative and interventional measures to aid urine storage and bladder emptying, along with containment of incontinence. A multidisciplinary approach to management is essential. DISCUSSION: The review offers a pragmatic review of management in the context of complex pathophysiology and varied evidence base. Neurourol. Urodynam. 35:657-665, 2016. © 2016 Wiley Periodicals, Inc.

Sexual dysfunction in patients with epilepsy.

Sexuality is an important and private aspect of life and sexuality and epilepsy have been intimately linked since ancient time. Disturbances of reproductive and sexual health are common in men and women with epilepsy. Multiple causes may lead to sexual dysfunction. The basis for hyposexuality has been attributed to both epilepsy and antiepileptic drug use, making it difficult to distinguish between the illness-specific and pharmacologic impacts on sexual functioning. Low levels of androgens are associated with sexual arousal insufficiency and sexual dysfunction. Data from animal studies support the hypothesis that hyposexuality occurs as a result of epileptiform activity in the temporal lobe, but not in the motor cortex. Enzyme-inducing antiepileptic drugs are metabolized in the hepatic P 450 system (e.g., 3A4, 2C9, 2C19), induce hepatic enzymes, increase the hepatic synthesis of sex hormone-binding globulin (SHBG), and increase the metabolism of sex hormones that might have an additional influence on sexuality in patients with epilepsy. When examining sexual dysfunction in men and women with epilepsy, the Arizona Sexual Experience Scale may be helpful in evaluating sexual function. Laboratory tests for estrogen, free and total testosterone, and serum SHBG may also be useful in evaluating sexual health.

Follow-up of the neuro-urological patient: a systematic review.

OBJECTIVES: To systematically review the long-term urological follow-up strategies for patients with neurogenic lower urinary tract dysfunction (NLUTD), focusing on three main groups of neurological diseases: (i) spinal cord injuries, (ii) spinal dysraphism, and (iii) multiple sclerosis. PATIENTS AND METHODS: Data acquisition comprised electronic search on the Medical Literature Analysis and Retrieval System Online (MEDLINE) database and the EMBASE database in August 2014 to retrieve English language studies. MEDLINE and EMBASE search included the following medical subject heading (MeSH) terms: (i) neurogenic bladder and (ii) neurogenic bladder dysfunction. Each of these terms was crossed with (i) long-term care and (ii) long-term surveillance. Only studies related to NLUTD and urological follow-up were included. Studies were also identified by hand search of reference lists and review articles. RESULTS: Initial records identified through database searching included 265 articles. In all, 23 articles were included in the quantitative synthesis. The proposed time schedule of investigations as well as the amount and type of investigation were different according to specific neurological lesions. They depend on the dysfunctional pattern of the lower urinary tract (LUT) and its risk profile. However, there is a lack of high-evidence level studies to support an optimal long-term follow-up protocol. CONCLUSIONS: The goal of neuro-urological management is the best possible preservation of upper urinary tract (UUT) and LUT function in relation to the individual neurological disorder. Regular and risk adapted controls ('urochecks') allow detection of risk-factors in time before irreversible changes of the LUT and UUT have occurred. With risk- and patient-oriented lifelong regular urological care an optimised quality of life and life-expectancy can be achieved, although there is a complete lack of high-evidence level studies on this topic.

Factors implicated in pathogenesis of urinary tract infections in neurogenic bladders: some revered, few forgotten, others ignored.

AIMS: To comprehensively review factors implicated in the pathogenesis of urinary tract infection in patients with neurogenic bladders, and to stimulate research, especially in the somewhat ignored and forgotten areas of this important clinical subject. METHODS: In addition to reviewing relevant articles on pubmed, some important articles from previous times which were not available online were also procured and reviewed. RESULTS: Intrinsic defence mechanisms including protective flora, anti-adherence mechanisms, urothelial, and immunological responses to bacterial binding and the blood supply to the urinary bladder may be impaired in patients with neurogenic bladders. Further, bacterial washout mechanisms may be compromised as a result of inefficient voiding, reflux, and altered hydrokinetics. Finally, catheterization itself contributes to urinary tract infection in patients with neurogenic bladders. CONCLUSIONS: In order to address the issue of urinary tract infection in patients with neurogenic bladders, multiple factors need to be looked into and corrected. Further research is required, especially in the area of compromised host defence mechanisms. An individualized approach, which attempts to optimize each factor is recommended.

GAG layer replenishment therapy for chronic forms of cystitis with intravesical glycosaminoglycans--a review.

AIMS: Glycosaminoglycan (GAG) layer replenishment is a cornerstone in the therapy of interstitial cystitis (IC). During the last years intravesical GAG layer replenishment has proven to be an effective treatment for overactive bladder (OAB), radiation cystitis, and recurrent urinary tract infections (UTIs). METHODS: Examination of different substances available for intravesical GAG replenishment and evaluation of the evidence for the treatment of the above-mentioned conditions. RESULTS: We searched the Medical Literature Analysis and Retrieval System Online (MEDLINE) database for studies on intravesical GAG replenishment. A total of 27 clinical studies remain relevant to this topic, many of them with mixed patient selection and suboptimal definition of symptom improvement/success. Two placebo controlled studies with hyaluronic acid failed to show superiority and have not been published. One active controlled randomized study has been published showing that chondroitin sulphate 0.2% has a clear benefit for OAB patients. Another study with chondroitin sulphate 2.0% failed to show statistically significant evidence, but was underpowered. CONCLUSIONS: A short number of randomized controlled studies confirm efficacy of intravesical GAG layer replenishment therapy. Concluded from the study background (which comprises also uncontrolled studies), so far chondroitin sulphate 0.2% is in favor for intravesical GAG layer replenishment therapy. In general, large-scale trials are urgently needed to underline the benefit of this type of therapy.

Voiding dysfunction in women: How to manage it correctly.

INTRODUCTION: Of women aged >40 years, 6% have voiding dysfunction (VD), but the definition for VD in women with respect to detrusor underactivity (DU) and bladder outlet obstruction (BOO) is not yet clear. In this review we address the current literature to define the diagnosis and treatment of VD more accurately. METHODS: We used the PubMed database (1975-2012) and searched for original English-language studies using the keywords 'female voiding dysfunction', 'detrusor underactivity', 'acontractile detrusor' and 'bladder outlet obstruction and urinary retention in women'. We sought studies including the prevalence, aetiology, pathogenesis, diagnosis and treatment of female VD. RESULTS: In all, 20 original studies were identified using the selected search criteria, and another 45 were extracted from the reference lists of the original papers. All studies were selected according to their relevance to the current topic and the most pertinent reports were incorporated into this review. CONCLUSION: Female VD might be related to DU or/and BOO. Voiding and storage symptoms can coexist, making the diagnosis challenging, with the need for a targeted clinical investigation, and further evaluation by imaging and urodynamics. To date there is no universally accepted precise diagnostic criterion to diagnose and quantify DU and BOO in women. For therapy, a complete cure might not be possible for patients with VD, therefore relieving the symptoms and minimising the long-term complications associated with it should be the goal. Treatment options are numerous and must be applied primarily according to the underlying pathophysiology, but also considering disease-specific considerations and the abilities and needs of the individual patient. The treatment options range from behavioural therapy, intermittent (self-)catheterisation, and electrical neuromodulation and neurostimulation, and up to urinary diversion in rare cases.

What are the causes and consequences of bladder overdistension? ICI-RS 2011.

AIMS: To report the outcome of the think tank on prolonged bladder overdistension from the 3rd ICI-RS meeting. METHODS: Prolonged bladder overdistension was discussed after acute urinary retention, its terminology, its prevalence, pathophysiology, and consequences, as well as prophylactic and therapeutic aspects. RESULTS: Acute prolonged bladder overdistension (ApBO) is a consequence of undetected or inadequately treated acute retention, and is mostly due to regional anesthesia, prolonged childbirth, or extensive surgery. Currently, there is no agreed terminology. A primary, temporary neurogenic detrusor dysfunction causing retention is associated with decreased or absent bladder sensation therefore patients do not complain, and management is delayed. Therapeutically, the first intervention is to drain the bladder. Recovery depends on whether reversible or irreversible damage has occurred. There are no good data to support the use of drugs or sacral neuromodulation. Intravesical electrostimulation is the only treatment that has specifically addressed this problem with encouraging results. There are no recent reports on the effect of surgery for myogenic bladder damage. CONCLUSION: ApBO is an important, but often unrecognized medical complication. There is a need for defining the terminology, for studies to record the incidence of different types of bladder overdistension, and to establish management strategies. Apart from clean intermittent self catheterization (CIC) there are no data justifying pharmacological or other therapies. Therefore, prevention is of paramount importance and there is a need to develop and test preventative strategies, which should then be incorporated in surgical registries.

Constipation and LUTS - how do they affect each other?

CONTEXT: Urinary bladder and rectum share a common embryological origin. Their autonomic and somatic innervations have close similarities. Moreover, the close proximity of these two organ systems could suggest that dysfunction in one may influence, also mechanically, the function of the other. Therefore, it is not surprising that defecation problems and lower urinary tract symptoms (LUTS) occur together, as reported in the literature. OBJECTIVE: To study the relationship between constipation and LUTS focusing on what is evidence-based. EVIDENCE ACQUISITION: We searched the Medical Literature Analysis and Retrieval System Online (MEDLINE) database in February 2010 to retrieve English language studies (from 1997 to 2009) and the 2005, 2006 and 2007 abstract volumes of the European Association of Urology (EAU), American Urological Association (AUA) and International Continence Society (ICS). EVIDENCE SYNTHESIS: We present the findings according to the studied population in four groups: (a) children, (b) middle-aged women, (c) elderly and (d) neuropathic patients. Most published studies that correlated rectal and bladder dysfunction were carried out in children or in young women. On the other hand, there are few studies regarding the association between constipation and LUTS in the elderly and in neuropathic patients. CONCLUSIONS: Several studies in children documented that constipation is linked to urinary tract problems, including infections, enuresis, vesicoureteral reflux and upper renal tract dilatation. The underlying pathophysiology of these findings has not yet been clearly defined. Studies in middle-aged women also support a high prevalence of constipation among patients suffering from urinary tract dysfunction. Furthermore, an association between constipation and urinary incontinence, as well as between constipation and pelvic organ prolapse, has been suggested. The only prospective study in constipated elderly with concomitant LUTS demonstrates that the medical relief of constipation also significantly improves LUTS. Finally, the available data on neuropathic patients suggest that stool impaction in the rectum may mechanically impede bladder emptying. However, most of the studies only include a small number of patients, are not prospective and are uncontrolled. Therefore, there is a need for large-scale, controlled studies to further improve evidence and to provide a valid recommendation for all groups, especially for the elderly and neuropathic patients.

Constipation and LUTS: how do they affect each other?

CONTEXT: Urinary bladder and rectum share a common embryological origin. Their autonomic and somatic innervations have close similarities. Moreover, the close proximity of these two organ systems could suggest that dysfunction in one may influence, also mechanically, the function of the other. Therefore, it is not surprising that defecation problems and lower urinary tract symptoms (LUTS) occur together, as reported in the literature. OBJECTIVE: To study the relationship between constipation and LUTS focusing on what is evidence-based. EVIDENCE ACQUISITION: We searched the Medical Literature Analysis and Retrieval System Online (MEDLINE) database in February 2010 to retrieve English language studies (from 1997 to 2009) and the 2005, 2006 and 2007 abstract volumes of the European Association of Urology (EAU), American Urological Association (AUA) and International Continence Society (ICS). EVIDENCE SYNTHESIS: We present the findings according to the studied population in four groups: (a) children, (b) middle-aged women, (c) elderly and (d) neuropathic patients. Most published studies that correlated rectal and bladder dysfunction were carried out in children or in young women. On the other hand, there are few studies regarding the association between constipation and LUTS in the elderly and in neuropathic patients. CONCLUSIONS: Several studies in children documented that constipation is linked to urinary tract problems, including infections, enuresis, vesicoureteral reflux and upper renal tract dilatation. The underlying pathophysiology of these findings has not yet been clearly defined. Studies in middle-aged women also support a high prevalence of constipation among patients suffering from urinary tract dysfunction. Furthermore, an association between constipation and urinary incontinence, as well as between constipation and pelvic organ prolapse, has been suggested. The only prospective study in constipated elderly with concomitant LUTS demonstrates that the medical relief of constipation also significantly improves LUTS. Finally, the available data on neuropathic patients suggest that stool impaction in the rectum may mechanically impede bladder emptying. However, most of the studies only include a small number of patients, are not prospective and are uncontrolled. Therefore, there is a need for large-scale, controlled studies to further improve evidence and to provide a valid recommendation for all groups, especially for the elderly and neuropathic patients.

Dose escalation improves therapeutic outcome: post hoc analysis of data from a 12-week, multicentre, double-blind, parallel-group trial of trospium chloride in patients with urinary urge incontinence.

BACKGROUND: Flexible dosing of anticholinergics used for overactive bladder (OAB) treatment is a useful strategy in clinical practice for achieving a maximum effective and maximum tolerated level of therapeutic benefit. In this post hoc analysis we evaluated the efficacy and tolerability of trospium chloride treatment for urinary urge incontinence (UUI) with focus on flexible dosing. METHODS: The data came from a 12-week, randomised, double-blind, phase IIIb study in which 1658 patients with urinary frequency plus urge incontinence received trospium chloride 15 mg TID (n = 828) or 2.5 mg oxybutynin hydrochloride TID (n = 830). After four weeks, daily doses were doubled and not readjusted in 29.2% (242/828) of patients in the trospium group, and in 23.3% (193/830) in the oxybuytnin group, until the end of treatment. We assessed the absolute reduction in weekly UUI episodes and the change in intensity of dry mouth, recorded in patients' micturition diaries. Adverse events were also evaluated. Statistics were descriptive. RESULTS: Dose escalation of either trospium or oxybutynin increased reduction in UUI episodes in the population studied. At study end, there were no relevant differences between the "dose adjustment" subgroups and the respective "no dose adjustment" subgroups (trospium: P = 0.249; oxybutynin: P = 0.349). After dose escalation, worsening of dry mouth was higher in both dose adjusted subgroups compared to the respective "no dose adjustment" subgroups (P < 0.001). Worsening of dry mouth was lower in the trospium groups than in the oxybutynin groups (P < 0.001). Adverse events were increased in the dose adjusted subgroups. CONCLUSIONS: Flexible dosing of trospium was proven to be as effective, but better tolerated as the officially approved adjusted dose of oxybutynin. TRIAL REGISTRATION (PARENT STUDY): The study was registered with the German Federal Institute for Drugs and Medical Devices (BfArM, Berlin, Germany), registration number 4022383, as required at the time point of planning this study.

Efficacy, tolerability and safety of propiverine hydrochloride in comparison to oxybutynin in children with urge incontinence due to overactive bladder: Results of a multicentre observational cohort study.

OBJECTIVE: To compare, in a retrospective observational cohort study, the efficacy, tolerability and safety of propiverine and oxybutynin in children with urge incontinence (UI) due to overactive bladder. PATIENTS AND METHODS: Medical records were scrutinized for children with UI. As a primary efficacy outcome variable the achievement of continence after treatment with variable doses of propiverine or oxybutynin was assessed. Weekly UI episodes and daily voiding frequency were evaluated as secondary efficacy outcomes. Tolerability was evaluated by the rate of adverse events, adverse drug reactions caused by antimuscarinics and premature treatment termination. RESULTS: At 16 study centres, 621 children aged 5-14 years with UI due to overactive bladder were enrolled. After anticholinergic treatment (437 propiverine, 184 oxybutynin) continence was achieved in 61.6% and 58.7% of the patients after 186 and 259 days, respectively. There were clinically relevant improvements in voiding frequency across treatment groups. Daily doses of propiverine were markedly below the recommendations (0.54 vs 0.8 mg/kg body weight), daily doses of oxybutynin were according to the recommendations (0.31 vs 0.2-0.4 mg/kg body weight) at treatment initiation. There was a significantly more favourable tolerability to propiverine than oxybutynin for the overall rate of adverse events (3.9% vs 16.3%, odds ratio 4.813), adverse drug reactions caused by propiverine or oxybutynin (2.8% vs 9.2%) and premature treatment termination due to adverse drug reactions (1.6% vs 4.4%). CONCLUSION: Propiverine and oxybutynin are effective in children with UI due to overactive bladder. Sufficient treatment periods of at least 2, preferably 3-4, months are the crucial factors for a successful treatment. The tolerability profile of propiverine is better than for oxybutynin.