A consensus statement on when to start clean intermittent self-catheterization: An untapped resource?

BACKGROUND: Clean intermittent self-catheterisation (CISC or ISC) is used by patients/carers to empty the bladder if needed. Sometimes the urethral lumen leading out of the bladder is blocked; sometimes, the bladder (detrusor) muscle itself or the autonomic motor nerves innervating the bladder are damaged, resulting in a failure of the detrusor muscle to work, leading to a failure of the bladder being able to empty adequately. Prior consensus as to the indications and timing of CISC has yet to be provided. This article aims to provide a multidisciplinary consensus view on this subject. CONCLUSION: It is evident that every patient needs to be considered individually, bearing in mind the symptoms and investigations to be considered. We emphasise the importance of considering the term Bladder Voiding Efficiency (BVE). One group of patients who might find CISC helpful are those with a neurological disorder; these include spinal injury patients, multiple sclerosis, Parkinson's, and a condition called cauda equina. Sometimes bladder problems are treated with anticholinergics, and others may be treated with Botox. These may cause the bladder not to empty at all, which is good for leaks but needs self-catheterisation to empty the bladder. In the past, hospitals used a permanent catheter called an 'indwelling' or a 'suprapubic' catheter. These can have side effects, including infections, stones, and pain. For CISC, disposable catheters are the best option for patients as they come in different sizes and styles to provide individualised care. In conclusion, we would like hospitals to consider each patient separately and not use a general 'one-size-fits-all' bladder function for these patients.

Urinary Symptoms Among People With Neurogenic Lower Urinary Tract Dysfunction (NLUTD) Vary by Bladder Management.

Objectives: To determine whether assessment and decision-making around urinary symptoms in people with neurogenic lower urinary tract dysfunction (NLUTD) should depend on bladder management. Methods: Three surveys of urinary symptoms associated with NLUTD (USQNBs) were designed specific to bladder management method for those who manage their bladders with indwelling catheter (IDC), intermittent catheter (IC), or voiding (V). Each was deployed one time to a national sample. Subject matter experts qualitatively assessed the wording of validated items to identify potential duplicates. Clustering by unsupervised structural learning was used to analyze duplicates. Each item was classified into mutually exclusive and exhaustive categories: clinically actionable ("fever"), bladder-specific ("suprapubic pain"), urine quality ("cloudy urine"), or constitutional ("leg pain"). Results: A core of 10 "NLUTD urinary symptoms" contains three clinically actionable, bladder-specific, and urine quality items plus one constitutional item. There are 9 (IDC), 11 (IC), and 8 (V) items unique to these instruments. One decision-making protocol applies to all instruments. Conclusion: Ten urinary symptoms in NLUTD are independent of bladder management, whereas a similar number depend on bladder management. We conclude that assessment of urinary symptoms for persons with NLUTD should be specific to bladder management method, like the USQNBs are.

Non-Antibiotic Prophylaxis for Recurrent UTIs in Neurogenic Lower Urinary Tract Dysfunction (NAPRUN): Study Protocol for a Prospective, Longitudinal Multi-Arm Observational Study.

INTRODUCTION: Patients with neurogenic lower urinary tract dysfunction (NLUTD) reliant on intermittent self-catheterization for bladder emptying are at an increased risk of recurrent urinary tract infections (rUTI). So far, the most common practice in the prevention of rUTIs is long-term low-dose antibiotic prophylaxis, phytotherapy, and immunomodulation, whereby antibiotic prophylaxis inevitably leads to the emergence of drug-resistant pathogens and difficulty in treating infections. Therefore, non-antibiotic alternatives in the prevention of rUTIs are urgently required. We aim to identify the comparative clinical effectiveness of a non-antibiotic prophylaxis regimen in the prevention of recurrent urinary tract infections in patients with neurogenic bladder dysfunction who practice intermittent self-catheterization. METHODS AND ANALYSIS: In this multi-centre, prospective longitudinal multi-arm observational study, a total of 785 patients practising intermittent self-catheterisation due to NLUTD will be included. After inclusion, non-antibiotic prophylaxis regimens will be instilled with either UroVaxom® (OM-89) standard regimen, StroVac® (bacterial lysate vaccine) standard regimen, Angocin®, D-mannose (oral dose 2 g), bladder irrigation with saline (once per day). The management protocols will be pre-defined, but the selection of the protocol will be at the clinicians' discretion. Patients will be followed for 12 months from the onset of the prophylaxis protocol. The primary outcome is to identify the incidence of breakthrough infections. The secondary outcomes are adverse events associated with the prophylaxis regimens and the severity of breakthrough infections. Other outcomes include the exploration of change in susceptibility pattern via the optional rectal and perineal swab, as well as health-related quality of life over time (HRQoL), which will be measured in a random subgroup of 30 patients. ETHICS AND DISSEMINATION: Ethical approval for this study has been granted by the ethical review board of the University Medical Centre Rostock (A 2021-0238 from 28 October 2021). The results will be published in a peer-reviewed journal and presented at relevant meetings. STUDY REGISTRATION NUMBER: German Clinical Trials Register: Number DRKS00029142.

Is EDSS Enough to Predict Risk of Upper Urinary Tract Damage in Patients with Multiple Sclerosis?

Lower urinary tract dysfunction is often observed in patients with multiple sclerosis (MS) and may be responsible for an increased risk of upper urinary tract (UUT) damage. Although there are well-known urodynamic risk factors for UUT damage, no clinical prediction parameters are clearly identified. We aimed to confirm the accuracy of the Expanded Disability Status Scale (EDSS) in predicting urodynamic risk factors for UUT deterioration and to assess other clinical parameters potentially predicting urodynamic risk factors. We retrospectively reviewed 201 patients with MS referred for primary neuro-urological work-up, including a video-urodynamic study (VUDS) from August 2009 to February 2020. Multivariate modeling revealed EDSS, male gender, and a number of LUTS as clinical parameters significantly associated with urodynamic risk factors for UUT damage (p = 0.06, p = 0.01, p = 0.02, respectively). A nomogram combining EDSS, male gender, and a number of different LUTS was created to predict the presence of at least one urodynamic risk factor for UUT damage. In conclusion, the presence of high EDSS combined with male gender and several different LUTS is significantly associated with urodynamic risk factors and can be used to stratify MS patients for further neuro-urological assessment and treatment.

Neurogenic Lower Urinary Tract Dysfunction in Asymptomatic Patients with Multiple Sclerosis.

Neurogenic lower urinary tract dysfunction (NLUTD) in asymptomatic patients with MS has been described in preliminary studies, but specific investigations of this topic are rare. Many authors advise early diagnosis and treatment of NLUTD in patients with MS. In contrast, clinical practice and different guidelines recommend neuro-urological diagnostics only in the presence of symptoms. Our aim was to investigate the characteristics of NLUTD and the correlations of clinical parameters with NLUTD in asymptomatic patients with MS. We evaluated bladder diaries, urodynamic findings, and therapy proposals. Correlations of the voided volume, voiding frequency, urinary tract infections, and uroflowmetry including post-void residual with the urodynamic findings were determined. In our study, 26% of the patients were asymptomatic. Of these, 73.7% had urodynamic findings indicative of NLUTD, 21.1% had detrusor overactivity, 13.2% had detrusor underactivity, 13.2% detrusor overactivity and detrusor sphincter dyssynergia, and 57.9% had radiologically abnormal findings of the bladder. No patients presented low bladder compliance or renal reflux. Clinical parameters from the bladder diary and urinary tract infections were found to be correlated with NLUTD, and the absence of symptoms did not exclude NLUTD in patients with MS. We observed that urinary tract damage is already present in a relevant proportion. Based on our results, we recommend that patients with MS be screened for NLUTD regardless of the subjective presence of urinary symptoms or the disease stage.

Psychometric properties of the Persian version of neurogenic bladder symptom score questionnaire: A methodological study on patients with multiple sclerosis and stroke.

OBJECTIVES: Concerning the impact of neurogenic lower urinary tract dysfunction (NLUTD) on quality of life, besides the lack of standard psychometrically-analyzed Persian tools, the present study investigated the validity and reliability of the Persian version of the neurogenic bladder symptom score (NBSS) questionnaire. METHODS: A total of 279 multiple sclerosis (MS) or stroke/cerebrovascular accident (CVA) patients over 18 years of age with NLUTD referred to the neurology clinics entered the study in 2021-2022. After translation, back-translation, and developing a Persian version, its validity and reliability were determined. The content validity index (CVI) and content validity ratio (CVR) were calculated quantitatively. To determine the internal consistency and scale reliability, a test-retest was used. RESULTS: The Cronbach's α coefficient was 0.83 and the intraclass correlation coefficient (95% confidence interval) was 0.85 (0.82, 0.88). Cronbach's α in all domains (incontinence, storage and voiding, and consequence) was greater than 0.70. The criterion validity also showed a positive correlation of NBSS with the International Consultation on Incontinence Questionnaire-overactive bladder (p < 0.001 and r = 0.55). The face validity was acceptable according to the opinion of 10 participants. To determine the CVI and the CVR, 10 experts' panels reviewed all items related to the questionnaire in terms of necessity, clarity, transparency, and relevancy. Based on the expert panel all NBSS criteria got a high score, and all criteria were essential to assess NLUTD (CVI: 0.78-1). CONCLUSIONS: Regarding validity and reliability, the Persian version NBSS questionnaire can properly evaluate NLUTD in MS or stroke/CVA patients.

A 15-year retrospective review of urodynamic studies in children at Red Cross War Memorial Children's Hospital, Cape town, South Africa.

BACKGROUND: Despite the undeniable diagnostic benefits of urodynamic studies (UDS), their adoption into clinical practice in Africa has been slow. This study aimed to review the use of invasive UDS in children at a tertiary paediatric hospital in South Africa. METHODS: A retrospective analysis of 1108 UDS was conducted. Patient demographic characteristics, primary diagnosis, indication and urodynamic outcomes were reviewed. Presence of urodynamic high-risk features were documented, and a comparison was made between the first study and follow-up study. RESULTS: This study revealed increasing trends in the use of UDS from 2015. Referrals were from Urology (37.7%), Spinal defects clinic (34.4%), Nephrology (20.8%) and other departments (7.0%). The most common reason for referral was review of medical treatment (36.5%). Spinal dysraphism (58.3%) accounted for the majority of conditions seen. Majority (59.1%) of the patients were receiving more than one type of bladder treatment at the time of their first study, with clean intermittent catheterisation (46.5%) being the most common form of bladder management. 97.5% of studies were performed using transurethral bladder catheterization. Urodynamic diagnosis was neurogenic in 74.0%, anatomical (12.2%), functional (8.8%) and normal (5.0%). There was statistically significant improvement in bladder compliance, detrusor leak point pressure and detrusor sphincter dyssynergia between the first study and a subsequent study following therapeutic intervention. CONCLUSIONS: The unique ability of UDS to demonstrate changes in detrusor pressures, which is a common reason for therapy failure, makes UDS an invaluable tool in the diagnosis and management of children with lower urinary tract dysfunction.

The role of spinal cord tractography in detecting lesions following selective bladder afferent and efferent fibers injury: A novel method for induction of neurogenic lower urinary tract dysfunction in rabbit.

OBJECTIVE: Neurogenic lower urinary tract dysfunction (NLUTD), a challenging disorder, is defined by lack of bladder control due to the abnormalities in neural pathways and can be classified based on the location of lesions within the nervous system, thus investigating the neural pathways can help us to know the site of the lesion and specify the class of the NLUTD. Diffusion Tensor Imaging (DTI) tractography, a noninvasive advanced imaging method, is capable of detecting central nervous system pathologies, even if routine magnetic resonance imaging shows no abnormality. Accordingly, tractography is an ideal technique to evaluate patients with NLUTD and visualize the pathology site within the spine. This study aimed to introduce a novel method of spinal cord injury (SCI) to establish NLUTD in the rabbit and to investigate the potential of tractography in tracing neural tracts of the spinal cord in an induced NLUTD animal model. MATERIALS AND METHODS: An animal model of NLUTD was induced through cauterization of the spinal cord at the level T12-L1 in 12 rabbits. Then rabbits were assessed via DTI, urodynamic studies (UDS), voiding cystourethrogram (VCUG), and pathology assessments using antineurofilament 200 (NF200) antibody, anti-S100, anti-Smooth Muscle Actin, anti-Myogenin, and anti-MyoD1. RESULTS: The tractography visualized lesions within spinal cord fibers. DTI parameters including fractional anisotropy (FA) value and tract density were significantly decreased (FA: p-value = 0.01, Tract density: p-value = 0.05) after injury. The mean diffusivity (MD) was insignificantly increased compared to before the injury. Also, the results of UDS and pathology assessments corroborated that applying SCI and the establishment of the NLUTD model was completely successful. CONCLUSION: In the present study, we investigated the auxiliary role of tractography in detecting the spinal cord lesions in the novel established rabbit model of NLUTD. The introduced method of NLUTD induction was without the leg's neurological deficit, easily applicable, low-cost, and was accompanied by minimal surgical preparation and a satisfactory survival rate in comparison with other SCI animal models.

Acute effect of sacral neuromodulation on video-urodynamic parameters of neurogenic lower urinary tract dysfunction in a patient with vesicoureteral reflux: a case report.

Neurogenic lower urinary tract dysfunction (NLUTD) is a common urological disease that causes long-term complications and severely reduces patient's quality of life. Sacral neuromodulation has proven to be an effective treatment for NLUTD. However, most previous studies have focused mainly on the efficacy and safety of sacral neuromodulation in the treatment of NLUTD and less on the changes in urodynamic parameters in patients before and after sacral neuromodulation. This study aimed to evaluate the effect of short-term sacral neuromodulation on the results of video-urodynamic parameters in a 63-year-old woman with NLUTD with vesicoureteral reflux. The patient was admitted to the Department of Urology of Beijing Hospital in January 2021 and examined using video-urodynamics. In the same month, the patient underwent the first stage of sacral neuromodulation, with an experience period of 2 weeks. After the experience period ended, video-urodynamics was performed again in February 2021. By comparing the two video-urodynamic results, the effect of short-term sacral neuromodulation on the anatomy and physiology of the lower urinary tract was determined. After 2 weeks of sacral neuromodulation treatment, video-urodynamic parameter analysis showed that while the urine storage period of the patient significantly improved, the voiding period was not significantly changed. This was specifically reflected in the improvement of bladder compliance, safe capacity of the bladder, and significant reduction in vesicoureteral reflux. The improvement of the safe capacity of the bladder effectively helped the patient to control the number of intermittent catheterizations within an acceptable range, which greatly improved her quality of life. Therefore, the patient underwent permanent sacral neuromodulation implantation in February 2021. This study suggests that short-term sacral neuromodulation can significantly improve lower urinary tract function and reduce vesicoureteral reflux in patients with NLUTD with vesicoureteral reflux. In short, we believe that sacral neuromodulation may be a good choice for patients with NLUTD.

Early Transcutaneous Tibial Nerve Stimulation Acutely Improves Lower Urinary Tract Function in Spinal Cord Injured Rats.

Despite the fact that a majority of patients with an injury to the spinal cord develop lower urinary tract dysfunction, only few treatment options are available currently once the dysfunction arises. Tibial nerve stimulation has been used in pilot clinical trials, with some promising results. Hence, we investigated whether the early application of transcutaneous tibial nerve stimulation in the animal model of spinal cord injured rats can prevent the development of detrusor overactivity and/or detrusor-sphincter-dyssynergia. Rats were implanted with a bladder catheter and external urethral sphincter electromyography electrodes. A dorsal over-hemisection, resulting in an incomplete spinal cord injury at the T8/9 spinal level, induced immediate bladder paralysis. One week later, the animals received daily tibial nerve or sham stimulation for 15 days. Effects of stimulation on the lower urinary tract function were assessed by urodynamic investigation. Measurements showed improvements of several key parameters of lower urinary tract function-in particular, non-voiding bladder contractions and intravesical pressure-immediately after the completion of the stimulation period in the stimulated animals. These differences extinguished one week later, however. In the dorsal horn of the lumbosacral spinal cord, a small significant increase of the density of C-fiber afferents layers I-II was found in the stimulated animals at four weeks after spinal cord injury. Tibial nerve stimulation applied acutely after spinal cord injury in rats had an immediate beneficial effect on lower urinary tract dysfunction; however, the effect was transitory and did not last over time. To achieve more sustainable, longer lasting effects, further studies are needed looking into different stimulation protocols using optimized stimulation parameters, timing, and treatment schedules.

Clinical Predictors of Neurogenic Lower Urinary Tract Dysfunction in Persons with Multiple Sclerosis.

BACKGROUND: Multiple sclerosis patients often develop neurogenic lower urinary tract dysfunction with a potential risk of upper urinary tract damage. Diagnostic tools are urodynamics, bladder diary, uroflowmetry, and post-void residual, but recommendations for their use are controversial. OBJECTIVE: We aimed to identify clinical parameters indicative of neurogenic lower urinary tract dysfunction in multiple sclerosis patients. METHODS: 207 patients were prospectively assessed independent of the presence of lower urinary tract symptoms. We analyzed Expanded Disability Status Scale scores, uroflowmetry, post-void residual, rate of urinary tract infections, standardized voiding frequency, and voided volume in correlation with urodynamic findings. RESULTS: We found a significant correlation between post-void residual (odds ratio (OR) 4.17, confidence interval (CI) 1.20-22.46), urinary tract infection rate (OR 3.91, CI 1.13-21.0), voided volume (OR 4.53, CI 1.85-11.99), increased standardized voiding frequency (OR 7.40, CI 2.15-39.66), and urodynamic findings indicative of neurogenic lower urinary tract dysfunction. Expanded Disability Status Scale shows no correlation. Those parameters (except post-void residual) are also associated with reduced bladder compliance, as potential risk for kidney damage. CONCLUSION: Therefore, bladder diary and urinary tract infection rate should be routinely assessed to identify patients who require urodynamics.

Slow development of bladder malfunction parallels spinal cord fiber sprouting and interneurons' loss after spinal cord transection.

Neurogenic lower urinary tract dysfunction typically develops after spinal cord injury. We investigated the time course and the anatomical changes in the spinal cord that may be causing lower urinary tract symptoms following injury. Rats were implanted with a bladder catheter and external urethral sphincter electromyography electrodes. Animals underwent a large, incomplete spinal transection at the T8/9 spinal level. At 1, 2-3, and 4 weeks after injury, the animals underwent urodynamic investigations. Urodynamic investigations showed detrusor overactivity and detrusor-sphincter-dyssynergia appearing over time at 3-4 weeks after injury. Lower urinary tract dysfunction was accompanied by an increase in density of C-fiber afferents in the lumbosacral dorsal horn. CRF-positive Barrington's and 5-HT-positive bulbospinal projections drastically decreased after injury, with partial compensation for the CRF fibers at 3-4 weeks. Interestingly, a decrease over time was observed in the number of GABAergic neurons in the lumbosacral dorsal horn and lamina X, and a decrease of glutamatergic cells in the dorsal horn. Detrusor overactivity and detrusor-sphincter-dyssynergia might therefore arise from a discrepancy in inhibitory/excitatory interneuron activity in the lumbosacral cord as well as input changes which develop over time after injury. The processes point to spinal plastic changes leading to malfunction of the important physiological pathway of lower urinary tract control.

Electrochemically activated solution as bladder irrigation-An individual curative trial in patients with neurogenic lower urinary tract dysfunction and recurrent urinary infections.

AIMS: Driven by increasing awareness of antibiotic stewardship, especially in the vulnerable group of patients with neurogenic lower urinary tract dysfunction (NLUTD), whose frequent need for invasive interventions leads to a high incidence of recurrent urinary tract infections (rUTIs), the goal was to find an alternative to antibiotic treatment. Our intention was for the treatment to be locally administered and well-tolerated as well as to avoid the risk of antimicrobial resistance. METHODS: A retrospective analysis of 12 catheterized NLUTD patients was performed within the setting of an individual curative trial. The decision to implement the investigational intervention was made on an individual basis with the aim of eliminating lower urinary tract bacteria before diagnostic procedures or to treat rUTI. Electrochemically activated solution (ECAS) was used as bladder irrigation (BI). The following assessments were undertaken: microbiological analysis of urine, analysis of leukocytes/erythrocytes (per µl urine); microbial resistance and sensitivity to antibiotics before and after therapy; clinical signs and patients' state of health. RESULTS: Eradication of bacteria or an increase in microbial sensitivity to antibiotics was observed in 50%-70% of patients. No adverse events were seen. Due to the restrictions of an individual curative trial, the results are limited by the small number of patients and the absence of a control group. CONCLUSION: In NLUTD patients with rUTIs, the use of ECAS BI to eliminate bacteriuria before invasive procedures (e.g., urodynamics, preoperative procedures) or to treat rUTI was shown to be a promising alternative to antibiotic treatment.

[Current aspects of neurogenic dysfunctions of the lower urinary tract in multiple sclerosis]. / Aktuelles zu neurogenen Dysfunktionen des unteren Harntraktes bei Multipler Sklerose.

BACKGROUND: In the clinical management of patients with multiple sclerosis (MS), the challenge is to make an early diagnosis and initiate adequate treatment of neurogenic disorders of the lower urinary tract (NLUTD). Various national guidelines provide practical recommendations which are sometimes discordant. OBJECTIVE: To develop a simple evidence-based algorithm for detecting NLUTD in patients with MS that could be taken as a principle for deriving therapeutic consequences. MATERIAL AND METHODS: A prospective multicenter study was initiated as a direct result of two multidisciplinary conferences. The aim was to identify statistically and clinically relevant parameters for the routine diagnosis of NLUTD in patients with MS. Urodynamic abnormalities served as the gold standard. At three subsequent consensus conferences, the results of the study were discussed, a diagnostic algorithm was developed and consensus was reached on a first-line treatment. RESULTS AND DISCUSSION: The proposed algorithm enables the detection of NLUTD in patients with MS with the help of four statistically significant predictors: 1) the residual urine volume, 2) the number of urinary tract infections (UTI) within the last 6 months, 3) the standardized micturition frequency and 4) the presence/absence of urinary incontinence. The newly developed algorithm has proved to be efficient with the following results: approximately 75% of the patients do not need a urodynamic examination for a first-line treatment decision. In 25% of cases, urodynamic examinations are essential for an adequate treatment decision. Routine assessments include the patient medical history, residual urine volume measurement, a micturition diary and a uroflowmetry (optional).

Intermittent catheterization with single- or multiple-reuse catheters: clinical study on safety and impact on quality of life.

PURPOSE: Intermittent catheterization (IC) is a proven effective long-term bladder management strategy for individuals who have lower urinary tract dysfunction. This study provides clinical evidence about multiple-reuse versus single-use catheterization techniques and if catheter choice can have an impact on health-related quality of life (HRQoL). METHOD: A prospective, multi-center, clinical trial studied patients who currently practiced catheter reuse, and who agreed to prospectively evaluate single-use hydrophilic-coated (HC) (i.e. LoFric) catheters for 4 weeks. A validated Intermittent Self-Catheterization Questionnaire (ISC-Q) was used to obtain HRQoL. Reused catheters were collected and studied with regard to microbial and debris contamination. RESULTS: The study included 39 patients who had practiced IC for a mean of 10 years, 6 times daily. At inclusion, all patients reused catheters for a mean of 21 days (SD = 48) per catheter. 36 patients completed the prospective test period and the mean ISC-Q score increased from 58.0 (SD = 22.6) to 67.2 (SD = 17.7) when patients switched to the single-use HC catheters (p = 0.0101). At the end of the study, 83% (95% CI [67-94%]) preferred to continue using single-use HC catheters. All collected reused catheters (100%) were contaminated by debris and 74% (95% CI [58-87%]) were contaminated by microorganisms, some with biofilm. CONCLUSION: Single-use HC catheters improved HRQoL and were preferred over catheter reuse among people practicing IC. Catheter multiple-reuse may pose a potential safety concern due to colonization by microorganisms as well as having reduced acceptance compared to single use. TRIAL REGISTRY NUMBER: ClinicalTrials.gov NCT02129738.

Intravesical vanilloids for treating neurogenic lower urinary tract dysfunction in patients with multiple sclerosis: A systematic review and meta-analysis. A report from the Neuro-Urology Promotion Committee of the International Continence Society (ICS).

AIMS: To systematically assess all available evidence on efficacy and safety of vanilloids for treating neurogenic lower urinary tract dysfunction (NLUTD) in patients with multiple sclerosis (MS). METHODS: This systematic review and meta-analysis was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. Studies were identified by electronic search of Cochrane register, Embase, Medline, Scopus, (last search January 8, 2016). RESULTS: After screening of 7848 abstracts, 4 randomized controlled trials (RCTs) and 3 prospective cohort studies were included. Pooled data from three RCTs evaluating intravesical capsaicin showed the standardized mean difference to be -2.16 (95% confidence interval [CI] -2.87 to -1.45) in incontinence episodes per 24 h and -0.54 (95%CI -1.03 to -0.05) in voids per 24 h. There was no statistically significant effect on maximum cystometric capacity and maximum storage detrusor pressure. Overall, adverse events were reported by >50% of the patients, most commonly were pelvic pain, facial flush, worsening of incontinence, autonomic dysreflexia, urinary tract infection and haematuria. Risk of bias and confounding was relevant in both RCTs and non-RCTs. CONCLUSIONS: Preliminary data suggest that intravesical vanilloids might be effective for treating NLUTD in patients with MS. However, the safety profile seems unfavorable, the overall quality of evidence is low and no licensed substance is currently available warranting well-designed, adequately sampled and properly powered RCTs.

High EDSS can predict risk for upper urinary tract damage in patients with multiple sclerosis.

BACKGROUND: Neurogenic lower urinary tract dysfunction (NLUTD) is very common in patients with multiple sclerosis (MS), and it might jeopardize renal function and thereby increase mortality. Although there are well-known urodynamic risk factors for upper urinary tract damage, no clinical prediction parameters are available. OBJECTIVE: We aimed to assess clinical parameters potentially predicting urodynamic risk factors for upper urinary tract damage. METHODS: A consecutive series of 141 patients with MS referred from neurologists for primary neuro-urological work-up including urodynamics were prospectively evaluated. Clinical parameters taken into account were age, sex, duration, and clinical course of MS and Expanded Disability Status Scale (EDSS). RESULTS: Multivariate modeling revealed EDSS as a clinical parameter significantly associated with urodynamic risk factors for upper urinary tract damage (odds ratio = 1.34, 95% confidence interval (CI) = 1.06-1.71, p = 0.02). Using receiver operator characteristic (ROC) curves, an EDSS of 5.0 as cutoff showed a sensitivity of 86%-87% and a specificity of 52% for at least one urodynamic risk factor for upper urinary tract damage. CONCLUSION: High EDSS is significantly associated with urodynamic risk factors for upper urinary tract damage and allows a risk-dependent stratification in daily neurological clinical practice to identify MS patients requiring further neuro-urological assessment and treatment.

Surveillance Strategies for Neurogenic Lower Urinary Tract Dysfunction.

Patients with neurogenic lower urinary tract dysfunction (NLUTD) experience significant morbidity and mortality due to urological complications including upper tract damage and bladder malignancy. This has led to increased surveillance in patients NLUTD. This article discusses the methods available for surveillance of patients with NLUTD and pulls information from the largest and most established organizations that have produced evidence-based surveillance guidelines for NLUTD. These organizations include the Paralyzed Veterans of America (PVA), US Department of Veterans Affairs, European Association of Urology (EAU), The NICE organization from the UK, and cites additional literature not been included in these documents.

Pharmacokinetics of intravesical versus oral oxybutynin in healthy adults: results of an open label, randomized, prospective clinical study.

PURPOSE: We investigated the pharmacokinetics of intravesical oxybutynin and discuss the clinical implications of the results. MATERIALS AND METHODS: We performed an open label, randomized, 3-period crossover clinical study in 20 healthy adults. In periods 1 and 2 subjects received a single dose of 10 mg oxybutynin HCl solution intravesically or a 5 mg tablet orally. Period 3 comprised repeat intravesical applications (7 doses) of 10 mg oxybutynin HCl. Enantioselective concentrations of oxybutynin and N-desethyloxybutynin were quantified by liquid chromatography-mass spectrometry. Pharmacokinetic parameters were calculated by noncompartmental methods, analyzed by descriptive statistics and compared using the average bioequivalence approach. RESULTS: Systemic exposure to racemic oxybutynin after intravesical administration was significantly greater, yielding 294% (90% CI 211-408) of that after oral intake of immediate release preparations, as measured by the dose normalized area under the plasma concentration time curve. In contrast, systemic exposure to racemic N-desethyloxybutynin reached only 21% (90% CI 15-29). The area under the plasma concentration time curve ratio of N-desethyloxybutynin to oxybutynin was 14-fold decreased for intravesical administration. After intravesical multidose administration, the cumulation of oxybutynin (1.3-fold) and N-desethyloxybutynin (1.6-fold) was weak, absorption was prolonged and apparent elimination half-lives were longer. The study medication was well tolerated with a third of participants reporting anticholinergic adverse effects. CONCLUSIONS: Our study provides evidence of significantly higher bioavailability of intravesical vs oral administration of oxybutynin due to circumvention of the intestinal first pass metabolism. Given the high efficacy and decreased rate of adverse effects, intravesical oxybutynin should be considered in patients with neurogenic lower urinary tract dysfunction who do not tolerate oral administration or in whom oral preparations fail to improve detrusor overactivity.

Prospective evaluation of sacral nerve modulation in children with validated questionnaires.

PURPOSE: Sacral neuromodulation for refractory urinary dysfunction in pediatrics shows promising results. We prospectively evaluated patients undergoing sacral neuromodulation using validated quality of life and bladder dysfunction questionnaires. MATERIALS AND METHODS: All patients were prospectively enrolled in the study. Two validated questionnaires were completed preoperatively, after lead placement and at all followups. The PedsQL™ 4.0 Generic Core Scale, which assesses quality of life and bladder dysfunction, was quantified using the Vancouver Nonneurogenic Lower Urinary Tract Dysfunction/Dysfunctional Elimination Syndrome (NLUTD/DES) questionnaire. The Wilcoxon matched pairs test was used for statistical analysis with p <0.05 considered significant. RESULTS: A total of 14 patients with a median age of 10 years were enrolled in the study. Median followup was 6 months. All patients underwent generator placement. No significant difference was seen in physical quality of life. Before and after lead placement mean ± SD psychosocial quality of life scores were 70.6 ± 17.4 and 81.43 ± 14.8 (p = 0.02), mean total quality of life scores were 75 ± 15.3 and 84.04 ± 13.2 (p = 0.006) and median NLUTD/DES scores were 23 ± 7.8 and 10.5 ± 7.0 (p <0.001), respectively. One month postoperatively a significant difference was seen in total quality of life and NLUTD/DES scores. Two patients required replacement of the temporary lead or generator. There were no infections. CONCLUSIONS: Patients undergoing sacral neuromodulation had significant improvement in NLUTD/DES scores, and psychosocial and overall total quality of life. Results were durable at 1 month. Continuing to follow these patients in a prospective manner with validated questionnaires will strengthen the current evidence supporting sacral neuromodulation in the pediatric population.