Needs, priorities, and attitudes of individuals with spinal cord injury toward nerve stimulation devices for bladder and bowel function: a survey.

STUDY DESIGN: Survey. OBJECTIVES: To investigate the needs and priorities of people with spinal cord injury for managing neurogenic bladder and bowel function and to determine their willingness to adopt neuromodulation interventions for these functions. METHODS: Anonymous online survey. It was advertised by word-of-mouth by community influencers and social media, and by advertisement in newsletters of advocacy groups. RESULTS: Responses from 370 individuals (27% female, 73% male) were included. Bladder emptying without catheters was the top priority for restoring bladder function, and maintaining fecal continence was the top priority for restoring bowel function. The biggest concerns regarding external stimulation systems were wearing a device with wires connecting to electrodes on the skin and having to don and doff the system daily as needed. The biggest concerns for implanted systems were the chances of experiencing problems with the implant that required a revision surgery or surgical removal of the whole system. Respondents were willing to accept an external (61%) or implanted (41%) device to achieve improved bladder or bowel function. CONCLUSIONS: Bladder and bowel dysfunction remain important unmet challenges for individuals living with SCI who answered our survey. These individuals are willing to accept some potential risks of nerve stimulation approaches given potential benefits. Additional consumer input is critical for guiding both research and translation to clinical use and personalized medicine.

Randomized Clinical Trial Using Sterile Single Use and Reused Polyvinylchloride Catheters for Intermittent Catheterization with a Clean Technique in Spina Bifida Cases: Short-Term Urinary Tract Infection Outcomes.

PURPOSE: Urinary tract infections are common and severe complications in patients with spina bifida. Management includes intermittent bladder catheterization with single use or reused sterile catheters. There is insufficient evidence to set a standard among the different techniques. We determined whether single use polyvinylchloride catheters would reduce urinary tract infections compared to reused polyvinylchloride catheters in patients with neurogenic bladder due to spina bifida. MATERIALS AND METHODS: We performed a 2-arm randomized parallel clinical trial from 2015 to 2016 with an 8-week followup at our center in patients with neurogenic bladder caused by spina bifida. Patients were divided into single use and reused polyvinylchloride catheter groups. Evaluations were done on days 0, 7, 14, 28, 42 and 56. Participants reported symptoms and urine cultures were obtained. The primary outcome was urinary tract infection frequency, defined as positive urine culture plus fever, flank pain, malaise, or cloudy or odorous urine. Study eligibility criteria were age 2 years or greater, spina bifida diagnosis with regular clean intermittent bladder catheterization and no urinary tract infection at initial evaluation. RESULTS: The calculated sample size was 75. Of the patients 135 were screened, 83 were randomized and 75 completed followup. Mean age was 12.7 years (range 2-56) and there were 29 males and 46 females. No statistical difference was found between the single use vs reused catheter groups in the frequency of asymptomatic bacteriuria (32.4% vs 23.7%, p = 0.398) or urinary tract infections (35.2% vs 36.8%, p = 0.877). CONCLUSIONS: Single use polyvinylchloride catheters for intermittent bladder catheterization did not decrease the incidence of urinary tract infections in our patients with neurogenic bladder compared to reused polyvinylchloride catheters. These results are consistent with the 2014 Cochrane Review.

[Prospective evaluation of mouth and eye dryness induced by antimuscarinic drugs used for neurogenic overactive bladder in 35 patients with multiple sclerosis]. / Évaluation prospective de l'impact des anticholinergiques sur la sécheresse buccale et oculaire chez 35 patients atteints de sclérose en plaque avec hyperactivité vésicale neurogène.

INTRODUCTION: Mouth and eye dryness are frequently reported by patients with multiple sclerosis (MS) as side effects of antimuscarinic drugs used for neurogenic overactive bladder. We evaluated the impact of antimuscarinic drugs prescription on these symptoms. METHODS: MS patients consulting for overactive bladder were included. Xerostomia were evaluated at baseline and thirty days after treatment by self-reporting questionnaires (Xerostomia Quality of Life [X-Qol] and Xerostomia Questionnaire [XQ]), by salivary flow rate and sugar test. Xerophtalmia were evaluated by a self-reporting questionnaire (Ocular Surface Disease Index [OSDI]) and Schirmer test. Iatrogenic anticholinergic impregnation was evaluated by the Anticholinergic Drug Scale. RESULTS: From January to December 2014, 35 patients were included. Mean age was 50.1±10.2 years, mean EDSS=4.9. Mean anticholinergic impregnation was 0.6±1.0. Before treatment, none correlation was found between anticholinergic impregnation and other parameters. Twenty-two patients were evaluated after treatment. At baseline and thirty days after treatment, mean scores were respectively: 0.78±0.51 and 0.73±0.43 (P=0.67) for X-Qol, 9.22±11.8 and 7.03±11.4 (P=0.32) for XQ, 18.8±14.9 and 13.9±11.6 (P=0.06) for OSDI. Mean salivary flow rates were respectively 1.54±1.11 and 1.22±1.3 (P=0.53), positive sugar tests concerned respectively 68% and 55% of patients (P=0.53), and positive Schirmer test concerned 50% before and after treatment. CONCLUSION: Eye and mouth dryness exist in our MS population, even before prescription of antimuscarinic treatment, and is not getting worse after prescription. Those symptoms should not be the reason to stop an efficient treatment, but should be the reason to find and treat their aetiology. LEVEL OF EVIDENCE: 4.

Cotransplantation with specific populations of spina bifida bone marrow stem/progenitor cells enhances urinary bladder regeneration.

Spina bifida (SB) patients afflicted with myelomeningocele typically possess a neurogenic urinary bladder and exhibit varying degrees of bladder dysfunction. Although surgical intervention in the form of enterocystoplasty is the current standard of care in which to remedy the neurogenic bladder, it is still a stop-gap measure and is associated with many complications due to the use of bowel as a source of replacement tissue. Contemporary bladder tissue engineering strategies lack the ability to reform bladder smooth muscle, vasculature, and promote peripheral nerve tissue growth when using autologous populations of cells. Within the context of this study, we demonstrate the role of two specific populations of bone marrow (BM) stem/progenitor cells used in combination with a synthetic elastomeric scaffold that provides a unique and alternative means to current bladder regeneration approaches. In vitro differentiation, gene expression, and proliferation are similar among donor mesenchymal stem cells (MSCs), whereas poly(1,8-octanediol-cocitrate) scaffolds seeded with SB BM MSCs perform analogously to control counterparts with regard to bladder smooth muscle wall formation in vivo. SB CD34(+) hematopoietic stem/progenitor cells cotransplanted with donor-matched MSCs cause a dramatic increase in tissue vascularization as well as an induction of peripheral nerve growth in grafted areas compared with samples not seeded with hematopoietic stem/progenitor cells. Finally, MSC/CD34(+) grafts provided the impetus for rapid urothelium regeneration. Data suggest that autologous BM stem/progenitor cells may be used as alternate, nonpathogenic cell sources for SB patient-specific bladder tissue regeneration in lieu of current enterocystoplasty procedures and have implications for other bladder regenerative therapies.

Neurogenic bladder and neuroendocrine abnormalities in Pol III-related leukodystrophy.

BACKGROUND: Pol III-related leukodystrophies, including 4H leukodystrophy, are recently recognized disorders that comprise hypomyelination and various neurologic and non-neurologic clinical manifestations. We report the unique neurologic presentation of the micturition dysfunction in Pol III-related leukodystrophy and describe the novel endocrine abnormalities in this entity. CASE PRESENTATION: A 32-year-old Caucasian female exhibited chronic urinary incontinence that commenced at the age of 7 years and remained the unexplained symptom more than two decades before the onset of progressive neurologic decline. A transient growth failure and absent sexual development with hypoprolactinemia appeared in the meanwhile. Neurologic, endocrine, neuroradiologic, and genetic evaluation performed only in the patient's thirties, confirmed the diagnosis of 4H leukodystrophy as the only cause of the micturition disturbance. CONCLUSION: The report shows for the first time that an unexplained chronic bladder dysfunction should be evaluated also as a possible 4H leukodystrophy, thus alerting to the unexpected neurologic and endocrine features in 4H leukodystrophy.

Myogenic bladder defects in mouse models of human oculodentodigital dysplasia.

To date, over 65 mutations in the gene encoding Cx43 (connexin43) have been linked to the autosomal-dominant disease ODDD (oculodentodigital dysplasia). A subset of these patients experience bladder incontinence which could be due to underlying neurogenic deterioration or aberrant myogenic regulation. BSMCs (bladder smooth muscle cells) from wild-type and two Cx43 mutant lines (Cx43(G60S) and Cx43(I130T)) that mimic ODDD exhibit a significant reduction in total Cx43. Dye transfer studies revealed that the G60S mutant was a potent dominant-negative inhibitor of co-expressed Cx43, a property not equally shared by the I130T mutant. BSMCs from both mutant mouse strains were defective in their ability to contract, which is indicative of phenotype changes due to harbouring the Cx43 mutants. Upon stretching, Cx43 levels were significantly elevated in controls and mutants containing BSMCs, but the non-muscle myosin heavy chain A levels were only reduced in cells from control mice. Although the Cx43(G60S) mutant mice showed no difference in voided urine volume or frequency, the Cx43(I130T) mice voided less frequently. Thus, similar to the diversity of morbidities seen in ODDD patients, genetically modified mice also display mutation-specific changes in bladder function. Furthermore, although mutant mice have compromised smooth muscle contraction and response to stretch, overriding bladder defects in Cx43(I130T) mice are likely to be complemented by neurogenic changes.

Endoscopic treatment of vesicoureteral reflux with non-simultaneous involuntary detrusor contraction in chronic spinal cord injury patients with neurogenic detrusor overactivity.

OBJECTIVE: To analyze whether it is correct to use endoscopic treatment via bulking agents of vesicoureteral reflux (VUR) seen on video urodynamics with non-simultaneous involuntary detrusor contraction in chronic spinal cord injury (SCI) patients with neurogenic detrusor overactivity (NDO). METHODS: A retrospective study was performed with a cohort of 76 patients (age 48.9 ± 14.4 years) (mean ± standard deviation) of both sexes with chronic SCI who underwent endoscopic treatment of VUR during the years 2008 to 2011. Patients were subjected to clinical examinations and video urodynamic studies preoperatively and 22 ± 11.4 months after the intervention. RESULTS: Resolution of VUR was achieved in 46 cases (61%). Cured patients had a statistically significant younger age and showed stress urinary incontinence more frequently. On the contrary, a greater grade of VUR, presence of bilateral reflux and presence of NDO were positively associated with treatment failure. The variables that independently influenced the cure of the reflux were NDO and reflux grade. CONCLUSIONS: The failure rate was high in patients with NDO, even though the reflux was not synchronous with involuntary detrusor contraction, and therefore these patients should have NDO eradicated before doing any anti-reflux procedures.

A novel animal model of underactive bladder: analysis of lower urinary tract function in a rat lumbar canal stenosis model.

AIMS: An animal model of neurogenic underactive bladder (UAB) has not been established. It was reported that a rat lumbar spinal canal stenosis (LCS) model created by cauda equina compression manifested intermittent claudication and allodynia. In this study, we examined the lower urinary tract function of the rat LCS model. METHODS: One small hole was drilled at the fifth lumbar vertebral arch (sham), and a rectangular piece of silicone rubber was inserted into the L5-L6 epidural space (LCS). Before and after surgery, a metabolic cage study was performed. After surgery, awake cystometry (CMG) and an in vitro muscle strip study were performed. Bladder morphology was evaluated by hematoxylin and eosin staining. RESULTS: The LCS rats showed a significant decrease in voided volume and a significant increase in postvoid residual volume and residual urine rate compared with Sham rats. CMG showed that the postvoid residual urine volume and numbers of non-voiding contractions significantly increased, while the voided volume, threshold pressure, and maximum intravesical pressure during voiding significantly decreased. There were no significant differences between sham and LCS rats in response to carbachol. In contrast, there was a significant increase in response to field stimulation, especially at lower frequencies, in LCS rats. LCS rats showed no obvious difference in detrusor morphology. CONCLUSIONS: This rat model requires a relatively simple surgical procedure and has characteristics of neurogenic UAB. It seems to be useful in the pathophysiological elucidation of UAB and might have potential for assessment of pharmacotherapy of UAB.

[Treatment of detrusor-striated sphincter dyssynergia with permanent nitinol urethral stent: results after a minimum follow-up of 2 years]. / Résultats à moyen terme du traitement de la dyssynergie vésicosphinctérienne par sphinctérotomie prothétique permanente.

OBJECTIVES: The aim of this study was to assess the outcomes of nitinol permanent urethral stents used in detrusor-striated sphincter dyssynergia (DSD) treatment on male patients with a spinal cord injury. MATERIALS: We investigated retrospectively all patients treated from 2004 to 2012. A total of 22 patients were included, with an age ranging from 22 to 76 years old. The DSD syndrome was due to spinal cord injury (18) or various spinal cord diseases (four) and treated with a nitinol urethral stent (11 Ultraflex(®) and 11 Mémotherm(®)). Every patient had an urodynamical study. The follow-up reached at least 2 years. RESULTS: The mean follow-up was 56 months (± 14). Complementary procedures after stenting included: five stent prolongation or displacement (mean interval 7.6 months), six bladder neck incisions (12.2 months), three urethrotomy (42 months), ten obstruction treated by laser (47.3 months). Eight patients had a change of their urinary pattern: four underwent ileal conduit diversion, one had a continent urinary diversion, one chose self intermittent catheterization, two were under indwelling catheterization waiting for another treatment. Stent retrieval was either harmful or impossible for four of them. Three patients were free of complementary procedures. CONCLUSIONS: Nitinol urethral stent was an effective treatment initially. However, by the third year, urethral stenosis and hypertrophic growth of the urethral mucosa usually require iterative endoscopic procedures (0.31 per patient per year). Patients treated with permanent uretral stent deserve a yearly endoscopic follow-up. Safety and effectiveness of permanent uretral stent compared to surgical sphincterotomy to treat DSD are discussed.

Intradetrusor onabotulinumtoxinA injections are significantly more efficacious than oral oxybutynin for treatment of neurogenic detrusor overactivity: results of a randomized, controlled, 24-week trial.

OBJECTIVE: To prospectively compare the results of intradetrusor onabotulinumtoxinA injections and oral oxybutynin for urinary continence, urodynamic parameters and quality of life in patients with neurogenic detrusor overactivity due to spinal cord injury. METHODS: Adult patients under intermittent catheterization were randomized 1:1 to receive one injection of onabotulinumtoxinA 300U or oxybutynin 5mg, per oris, three times/day. Primary study endpoint was change in urinary incontinence episodes/24 hours and secondary study endpoints were maximum cystometric capacity, maximum detrusor pressure, bladder compliance and quality of life before randomization and at week 24. RESULTS: Sixty-eight patients participated in the trial. Significant improvements in urinary incontinence per 24 hours, all investigated urodynamic parameters and quality of life were observed in both groups. Compared with oral oxybutynin, onabotulinumtoxinA was significantly more efficacious for all parameters investigated. Non-response to treatment was higher for oral oxybutynin (23.5%) than onabotulinumtoxinA (11.8%). Dry mouth was the most common adverse in patients with oral oxybutynin (72%) and transient macroscopic hematuria in patients with onabotulinumtoxinA (28%). Only one patient with oral oxybutynin dropped out the study because of adverse effects. CONCLUSION: The comparison of the two study drugs showed that onabotulinumtoxinA was significantly more efficacious than oral oxybutynin with regard to continence, urodynamic parameters and quality of life. Clinicaltrials.gov: NCT:01477736.

Case of primary Sjogren's syndrome preceded by dystonia.

There are only six cases in literature that describe development of dystonia with Sjogren's syndrome (SS). We describe a case of a 43-year-old woman who presented with symptoms including movement disorder, sensory neurogenic bladder, sensory loss and neuropathic pain, migraine like headaches, musculoskeletal pain, Raynaud's phenomenon and dysautonomia. Symptoms started in 2000, with weakness that progressed to dystonia in 2003. Diagnostic work-up was inconclusive with negative inflammatory serologies, cerebrospinal fluid and MRI for many years. After patient developed sicca syndrome with dry eyes and mouth in 2009, her rheumatoid factor titre was elevated (550 IU/mL), erythrocyte sedimentation rate, anti-Sjogrens syndrome-related antigen A (anti-Ro/SSA) and anti-SSB/La: anti-Sjogrens syndrome-related antigen B (anti-La/SSB) became positive. Lip biopsy confirmed diagnosis of SS. She was diagnosed with primary SS with neurological involvement. Her symptoms responded well to intravenous methylprednisolone. Symptoms stabilised with trials of immune-suppressive therapy. This is a case that demonstrates the delay of diagnosing SS with preceding unique neurological association.

A novel use of dextranomer/hyaluronic acid copolymer.

The aim of this study is to present a novel use of Dextranomer/hyaluronic acid copolymer (Deflux) for the treatment of a complicated iatrogenic chronic urethral injury. A 12-year-old boy with a neuropathic bladder presented a groove in the urethral mucosa due to chronic clean intermittent catheterizations (CICs) and suffered a posterior urethral injury during a failed catheterization for a routine examination. The defect on the urethral wall was repaired using Deflux, a technique that is not described in the literature. After the intervention the patient is continuing CICs without further complications.

Preliminary study of a genetically engineered spinal cord implant on urinary bladder after experimental spinal cord injury in rats.

The objective of this study was to determine the effect of neurotrophin-secreting Schwann cell implants on the urinary bladder after spinal cord contusion. One hour after severe spinal cord contusion at the T8 to T11 level, carbon filaments containing nonsecreting Schwann cells, brain-derived neurotrophic factor (BDNF)-secreting Schwann cells, neurotrophin-3 (NT-3)-secreting Schwann cells, or Schwann cells secreting both BDNF and NT-3 were implanted into the spinal cord. Untreated spinal cord injured (SCI) rats and noncontused rats (C) were also studied. Two months after spinal cord injury, cystometry was performed and the bladders were studied using light microscopy. SCI rats had significantly increased bladder mass, thickness, and smooth muscle mass compared to C rats. Bladder capacity of SCI rats and rats with spinal cord implants were both significantly greater than that of C rats. This preliminary study suggests that neurotrophin-secreting Schwann cell implants may lead to improved bladder structure after spinal cord injury.

Efficacy and safety of tolterodine in people with neurogenic detrusor overactivity.

OBJECTIVE: To compare tolterodine with oxybutynin and placebo in people with neurogenic detrusor overactivity. DESIGN: Prospective, randomized, double-blind, crossover trial plus open-label comparative stage. PARTICIPANTS: Ten participants with neurogenic detrusor overactivity due to spinal cord injury or multiple sclerosis who used intermittent catheterization. METHODS: Bladder capacity on cystometrogram, a 10-day record of catheterization volumes, number of incontinent episodes per day, and perceived dry mouth using a visual analog scale (VAS) were measured for the following: (a) a blinded comparison: tolterodine, 2 mg twice daily, vs placebo, twice daily; and (b) an unblinded comparison: oxybutynin vs tolterodine, each at self-selected doses (SSDs). RESULTS: Tolterodine, 2 mg twice daily, was superior to placebo in enhancing catheterization volumes (P < 0.0005) and reducing incontinence (P < 0.001), but was comparable with placebo in cystometric bladder capacity. Efficacy of tolterodine SSD was comparable with oxybutynin SSD with regard to catheterization volumes, degree of incontinence, and cystometric bladder capacity. The side effect profile (dry mouth) was comparable between tolterodine, 2 mg twice daily, and placebo, but differed significantly when comparing tolterodine SSD with oxybutynin SSD (P < 0.05). CONCLUSION: Tolterodine, when used at SSDs, is comparable with oxybutynin at SSDs in enhancing bladder volume and improving continence, but with less dry mouth. Tolterodine at the recommended dosage of 2 mg twice daily improves incontinence and bladder volumes compared with placebo, and without significant dry mouth. Larger doses of tolterodine may be needed to achieve best effect in this population, but further studies are required.

Bladder management in patients with pediatric onset neurogenic bladders.

Our objective was to determine which clean intermittent catheterization (CIC) methods and supplies were used by patients with pediatric onset neurogenic bladders and to relate methodology and materials to reported urinary tract infections. Data were collected via questionnaires distributed by mail and at clinic visits at our university tertiary care outpatient pediatric rehabilitation clinic. Questionnaires were given to 165 patients. Fifty-nine percent were returned (68 patients with myelomeningocele, 27 with pediatric onset spinal cord injury (SCI) and two with other diagnoses). Mean age was 12 years (range 1-27). Fifty-four percent of patients participated in their own CIC. Only two percent used sterile catheterization technique, whereas 98 percent used CIC. A sterile catheter was employed with clean technique by 22 percent. Catheters were reused by 76 percent. Subjects used a wide ranging number of catheters per month, with a median of 5.3. There was no correlation between the number of urinary tract infections (UTIs) per year and the type of catheter used or the use of prophylactic antibiotics. Compared with patients with myelomeningocele, subjects with SCI were significantly more likely to use sterile catheters (p = 0.04), > 10 catheters per month (p = 0.01) and gloves (p < 0.001). Subjects who used gloves or more catheters were more likely to experience UTI. These data suggest that clean reused supplies are not related to an increased likelihood of UTI and should be considered a way to lower costs in these populations.

[New pharmacological treatment concepts for overactive bladder]. / Neue pharmakologische Therapiekonzepte bei instabiler Blase.

Muscarinic receptor antagonists such as oxybutynin, propiverine, tolterodine, or trospium are the basis of medical treatment for overactive bladder. While they are moderately efficacious, their use can be limited by adverse effects such as dry mouth. This has sparked the search for new treatment options. Vanilloid receptor agonists, tachykinin receptor antagonists, potassium channel openers, and beta(3)-adrenoceptor agonists are currently under investigation, but are unlikely to become clinically available in the next few years. Therefore, current attempts to optimize treatment focus on improvement of existing drugs by new pharmaceutical formulations. Indeed, extended release formulations of oxybutynin (not available in Germany) or tolterodine have demonstrated an improved tolerability in clinical studies which was accompanied by an efficacy at least equal to that of their standard formulations.

Intradetrusor onabotulinumtoxinA injections are significantly more efficacious than oral oxybutynin for treatment of neurogenic detrusor overactivity: results of a randomized, controlled, 24-week trial / Injeções intradetrusoras de onabotulinumtoxinA são significativamente mais eficazes que oxibutinina oral para tratamento da hiperatividade detrusora neurogênica: resultados de estudo randomizado e controlado de 24 semanas

ABSTRACT Objective To prospectively compare the results of intradetrusor onabotulinumtoxinA injections and oral oxybutynin for urinary continence, urodynamic parameters and quality of life in patients with neurogenic detrusor overactivity due to spinal cord injury. Methods Adult patients under intermittent catheterization were randomized 1:1 to receive one injection of onabotulinumtoxinA 300U or oxybutynin 5mg, per oris, three times/day. Primary study endpoint was change in urinary incontinence episodes/24 hours and secondary study endpoints were maximum cystometric capacity, maximum detrusor pressure, bladder compliance and quality of life before randomization and at week 24. Results Sixty-eight patients participated in the trial. Significant improvements in urinary incontinence per 24 hours, all investigated urodynamic parameters and quality of life were observed in both groups. Compared with oral oxybutynin, onabotulinumtoxinA was significantly more efficacious for all parameters investigated. Non-response to treatment was higher for oral oxybutynin (23.5%) than onabotulinumtoxinA (11.8%). Dry mouth was the most common adverse in patients with oral oxybutynin (72%) and transient macroscopic hematuria in patients with onabotulinumtoxinA (28%). Only one patient with oral oxybutynin dropped out the study because of adverse effects. Conclusion The comparison of the two study drugs showed that onabotulinumtoxinA was significantly more efficacious than oral oxybutynin with regard to continence, urodynamic parameters and quality of life. Clinicaltrials.gov: NCT:01477736.

RESUMO Objetivo Comparar prospectivamente os resultados de injeções intradetrusoras de onabotulinumtoxinA e oxibutinina oral em pacientes com hiperatividade neurogênica do detrusor devido à lesão da medula espinhal, para avaliar a continência urinária, os parâmetros urodinâmicos e a qualidade de vida. Métodos Pacientes adultos em cateterismo intermitente foram randomizados 1:1 para tratamento com uma injeção de onabotulinumtoxinA 300U ou oxibutinina 5mg via oral, três vezes por dia. O desfecho primário foi alteração nos episódios de incontinência urinária em 24 horas, e os secundários foram capacidade cistométrica máxima, pressão máxima do detrusor, complacência vesical e qualidade de vida antes da randomização e na 24ª semana. Resultados Participaram do estudo 68 pacientes. Observou-se melhora significativa na incontinência urinária por 24 horas em todos os parâmetros urodinâmicos investigados e na qualidade de vida em ambos os grupos. Em comparação com a oxibutinina oral, a onabotulinumtoxinA foi significativamente mais eficaz para todos os parâmetros investigados. A falha no tratamento foi maior para oxibutinina oral (23,5%) em comparação com onabotulinumtoxinA (11,8%). A boca seca foi o evento adverso mais comum em pacientes tratados com oxibutinina oral (72%), e a hematúria macroscópica transitória naqueles tratados com onabotulinumtoxinA (28%). Apenas um paciente tratado com oxibutinina oral interrompeu o estudo por conta dos efeitos adversos. Conclusão A comparação dos dois fármacos do estudo mostrou que onabotulinumtoxinA foi significativamente mais eficaz que oxibutinina oral em relação a continência, parâmetros urodinâmicos e qualidade de vida. Clinicaltrials.gov: NCT:01477736.

Efficacy and safety of oxybutynin transdermal system in spinal cord injury patients with neurogenic detrusor overactivity and incontinence: an open-label, dose-titration study.

OBJECTIVES: To evaluate the efficacy and safety of oxybutynin transdermal system (oxybutynin-TDS) in spinal cord injury patients with neurogenic detrusor overactivity and incontinence despite use of clean intermittent catheterization (CIC). METHODS: This multicenter, open-label, dose-titration study included patients > or = 18 years old. During an 8-week dose-titration period, oxybutynin-TDS doses were adjusted every 2 weeks, depending on symptoms. The primary efficacy end point was a change in daily number of CIC periods without leakage, from baseline to 8 weeks or last observation. Outcome parameters included 3-day voiding diary, CIC volume, and urodynamic parameters. Changes from baseline were analyzed with paired t tests. RESULTS: Of 24 study participants (mean age, 41.9 years), 18 (75.0%) completed the study. Final oxybutynin-TDS doses were 7.8, 9.1, and 11.7 mg/d for 4, 9, and 11 patients, respectively. Daily number of CIC periods without leakage increased significantly (mean change, 1.5 + or - 2.2; P = .0036) from baseline (2.4 + or - 1.8) to 8 weeks (3.9 + or - 1.9). CIC volume (P = .0029), reflex volume (P = .0466), maximal cystometric bladder capacity (P = .0009), and residual urine volume (P = .0023) all increased significantly, whereas detrusor pressure at maximal bladder capacity decreased significantly (P = .0457). The most common adverse events were application site reaction (12.5% of patients), dry mouth (8.3%), and abnormal vision (8.3%). No patient discontinued treatment because of an adverse event. CONCLUSIONS: Oxybutynin-TDS was efficacious in spinal cord injury patients with neurogenic detrusor overactivity and was well tolerated at up to 3 times the standard dose.

Complications of clean intermittent catheterization in young females with myelomeningocele: 10 to 19 years of followup.

PURPOSE: We evaluated the rate of complications associated with catheterization and the risk of urethral lesions in girls with myelomeningocele treated with clean intermittent catheterization for a minimum of 10 years. MATERIALS AND METHODS: We examined the medical records of 31 females with myelomeningocele followed from the start of clean intermittent catheterization until age 11 to 20 years. Catheterization had been performed for a median of 15 years (range 10 to 19). Altogether, catheterization was used for a total of 459 patient-years. Noncoated polyvinyl chloride catheters were used in all cases. Anticholinergic treatment was given during 176 of the patient-years. RESULTS: Complications of catheterization were recorded in 13 patients on 20 occasions. Macroscopic hematuria was seen in 4 individuals. In 2 patients the hematuria was caused by urethral polyps that were cured by resection. Difficulties with catheterization occurred in 12 patients. The problems were solved by temporary use of lubrication or by other minor changes in management. There were no difficulties recorded after puberty. The risk of difficulties at catheterization doubled with the use of a Ch8 to Ch10 catheter compared to a Ch12 or larger catheter, and doubled during assisted clean intermittent catheterization compared to clean intermittent self-catheterization. CONCLUSIONS: There were remarkably few problems associated with clean intermittent catheterization in these females with myelomeningocele, despite long treatment periods and use of noncoated polyvinyl chloride catheters. Clean intermittent self-catheterization and large size catheters were associated with few complications.