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Showing 1-20 of 34 trials
NCT07507331
This observational study aims to evaluate the cross-cultural adaptation and psychometric properties of the Turkish version of the Neurogenic Bladder Symptom Score Short Form (NBSS-SF) in adults with spinal cord injury or multiple sclerosis who have neurogenic lower urinary tract dysfunction. Neurogenic bladder symptoms, such as urinary incontinence, urgency, and difficulties with urine storage or emptying, may negatively affect daily functioning and quality of life. In this study, the validity and reliability of the Turkish NBSS-SF will be examined, and convergent validity will be assessed through its relationship with the King's Health Questionnaire (KHQ) and the Short Form-12 (SF-12). In eligible participants, the scale will be administered again after 7 to 14 days. The aim of the study is to provide a valid and reliable Turkish patient-reported outcome measure for use in clinical practice and research.
NCT06588010
Recurrent urinary tract infections (UTIs) in patients with a neurogenic bladder using clean intermittent catheterization (CIC) are a major problem. In this population, urinary tract infections are the most frequent cause of morbidity and the second leading cause of mortality (Buzzell A, Spinal Cord, 2020). It is also the leading cause of healthcare use and consumption (A. Dinh, MMI 2019). In addition, multidrug-resistant bacteria (MRB) are frequently implicated, accounting for up to 50% of cases (Samal V BMC Infect Dis 2022, A. Dinh Spnal cord 2016), due to high exposure to antibiotics and frequent and prolonged hospitalisations. The very frequent recurrence of urinary tract infections encourages exposure to antibiotics, so prevention is of vital importance. Prevention based on treatments other than antibiotics (non-antibiotic prophylaxis) is of the greatest interest, not only to prevent UTIs, but also to reduce exposure to antibiotics and the ecological pressure they exert. However, few strategies are available, and very few have been well evaluated in high-risk populations. Bacterial lysates such as Escherichia Coli extract (OM-89), an immunoactive prophylaxis, are an original and innovative strategy that has been developed for the prevention of recurrent UTIs, and could constitute a therapeutic option in particularly at-risk populations. In vivo studies have shown that OM-89 : * increases IgA levels in intestinal secretions and in the urine of mice (Bosh AV Immunopharmacol Immunotoxicol 1988; Baier W Arzneim Forsch Drug Res 1997), * stimulates the production of serum IgG and IgA recognising a number of bacteria isolated from patients with urinary tract infections and enterohaemorrhagic E. coli infections (Huber M, Int J immunopharmacol 2000), * stimulates the killing capacity of rabbit polymorphonuclear leukocytes against E. coli and S. aureus (Nauck M, Int J Exp Clin Chemother 1991), * protects against acute infection with E. coli or P. aeruginosa, * and inhibits inflammation associated with lipopolysaccharide-induced cystitis in mice (Lee SJ, World J Urol 2006). Clinically, certain studies in patients with recurrent UTIs have shown a significant reduction in the number of urinary tract infections with OM-89 compared to placebo or an antibiotic (Bauer Eur Urol 2005; Naber KG Int J Antimicrob Agents 2009; Wade DT, Clin Rehabil 2020). However, these promising results suffer from methodological limitations and need to be confirmed by a high-quality trial carried out on a sample appropriate to the research question and in a homogeneous patient population. Patients with spinal cord injuries are a population at high risk of recurrent UTIs, and prevention is a major issue, given the incidence of MRBs in this population. It is therefore important in this high-risk population not only to rigorously evaluate the efficacy of OM-89 in reducing antibiotic consumption for UTIs, but also to assess its impact on bacterial resistance and on the microbiota (urinary and digestive). These patients could therefore see significant benefits: less frequent urinary tract infections and reduced antibiotic use. In addition, this population could serve as a model for other populations with or without neurological impairment suffering from recurrent UTIs
NCT07308808
The goal of this clinical trial is to determine whether Lactobacillus crispatus strains isolated from the lower urinary tracts of adult women can be used as an antibiotic-sparing treatment for urinary symptoms and urinary tract infection (UTI) among adults with neurogenic lower urinary tract dysfunction (NLUTD). The main question\[s\] it aims to answer are: 1. To identify soluble bactericidal compounds produced by urinary isolates of L. crispatus that kill uropathogenic E. coli (UPEC). 2. To determine if intravesical instillation of L. crispatus is safe and well tolerated in adults with NLUTD due to SCI who use intermittent catheterization (IC). If there is a comparison group: Researchers will compare L. Crispatus to standard care saline to see if there is a difference in urinary symptoms and urinary microbiome. Participants will be asked to complete daily symptom surveys, complete 2 bladder instillations, and collect, freeze, and return 14 urine samples.
NCT04187027
This study was conducted to assess the efficacy of pulsed electromagnetic field therapy on neurogenic bladder in children with myelomeningocele .Intervention: A pretest-post test controlled study was conducted in out-patient clinic in faculty of physical therapy Cairo university.
NCT05681936
Building on recent improvements, state-of-the-art functional MRI will be applied as an advanced diagnostic tool for the lumbosacral cord in spinal cord injury (SCI) patients to characterize the remaining neuronal activity of the motor and sensory neurons. Alterations in the activity pattern will reveal the effect upon task-related spinal cord activity of the lower motor neurons and sensory neurons undergoing trauma-induced neurodegeneration, at a spatial specificity that has not been possible so far. Results of this study will be of crucial importance because SCI patients can only profit from regeneration-inducing therapies if spinal neuronal function is preserved below the level of lesion.
NCT05726786
The goal of this clinical trial research study is to evaluate the impact of preoperative oral immunonutrition (IN) on post-operative complications in patients undergoing a cystectomy. As a secondary focus, this study will aim to develop a signature that would identify patients that would benefit the most from IN. This is a multicentric (Swiss: N=3), prospective, controlled, pragmatic, parallel-group comparative study with block randomization stratified by centers.
NCT04323735
The objectives of the proposed research among this population are: 1) to define clinically meaningful change (i.e. differentiating states of health and illness) with respect to urinary symptoms, urine inflammation, cultivable bacteria, and the urine ecosystem; and 2) to determine the optimal intravesical Lactobacillus RhamnosusGG (LGG®) dose to be used to reduce urinary symptoms in a future clinical trial.
NCT04315142
Many patients with neurological diseases suffer from neurogenic lower urinary tract dysfunction (NLUTD), which often severely impairs quality of life, due to urinary urgency with or without incontinence and voiding dysfunction. In addition, the upper urinary tract may be jeopardized because of high intravesical pressure caused by detrusor overactivity (DO) with concurrent detrusor-sphincter-dyssynergia and/or low bladder compliance. The treatment of NLUTD is a challenge since conventional conservative therapies often fail and more invasive treatments such as intradetrusor onabotulinumtoxinA injections, bladder augmentation and urinary diversion have to be considered. Neuromodulation therapies including tibial nerve stimulation (TNS) may be alternative non-invasive treatment options. Indeed, TNS is an effective and safe treatment for idiopathic overactive bladder proven in randomised controlled trials (RCTs), but its value in neurological patients is unclear. In a recent systematic review, the investigators found evidence that TNS might become a promising treatment option for NLUTD, however, more reliable data from well-designed RCTs are urgently needed to reach definitive conclusions. However, this study will be the first adequately sampled and powered, randomised, sham-controlled, double-blind trial assessing transcutaneous TNS (TTNS) for NLUTD. It will provide significant insights into the efficacy of TTNS in patients suffering from NLUTD and in the case that this treatment is really effective in the neurological population, the investigators findings would completely revolutionize the management of NLUTD in daily clinical practice. Moreover, this interdisciplinary clinical trial will relevantly influence the neurological and urological approach in the management of NLUTD promoting future collaborative projects improving patients' medical care and underlying the pioneering role of Switzerland in the rapidly developing and ambitious research field of neuro-urology.
NCT05207826
Determining the most appropriate time to evaluate detrusor activity in urodynamic studies for both traumatic and non-traumatic spinal cord injuries
NCT04373512
The objectives of the proposed research among this population are: 1) to define clinically meaningful change (i.e. differentiating states of health and illness) with respect to urinary symptoms, urine inflammation, cultivable bacteria, and the urine ecosystem; and 2) to determine the optimal intravesical Lactobacillus RhamnosusGG (LGG®) dose to be used to reduce urinary symptoms in a future clinical trial.
NCT05312138
Urinary symptoms are frequently seen in patients with Multiple Sclerosis (MS). Early evaluation of the patients in terms of the urinary system, planning the appropriate treatment and following up at regular intervals are extremely important in terms of preventing urinary system complications. Neuromodulation applications are used reliably in the urological treatment of MS patients. The aim of this study was to compare the efficacy of different neuromodulation techniques, transcutaneous posterior tibial nerve stimulation and repetitive transcranial magnetic stimulation, in patients with MS reporting lower urinary tract symptoms.
NCT01293110
Patients with neurological disease/injury often suffer from lower urinary tract symptoms, which frequently have a negative impact on the patients' health related quality of life. The prevalence of lower urinary tract dysfunction is high and the treatment is a challenge because available treatments may fail. In this study data of patients with lower urinary tract dysfunction treated at the University of Zürich, are prospectively and systematically collected in a database.
NCT06429631
Neurogenic bladder is a condition that occurs due to nerve damage or congenital problems and causes urination disorders. Nowadays, in individuals diagnosed with neurogenic bladder, Clean Intermittent Catheterization is often used to evacuate the urine accumulated in the bladder. Clean Intermittent Catheterization(CIC) is a simple, safe and effective method in which the catheter is placed through the meatus. In this application, the catheter is removed without waiting after urine drainage is achieved. This process is usually performed on its own. Since IC(Intermittent Catheterization) is a procedure performed on the bladder, it may cause some complications. IC application must be performed successfully to prevent or reduce complications. The success of the technique largely depends on patient education and follow-up. Sometimes patients may not be able to come to the hospital for follow-up and feedback after IC training. Innovations are needed to ensure the continuation of distance education so that the education of patients who cannot come to the hospital is not incomplete. The literature includes brochures, videos, websites and some mobile applications for IC training. However, no application has been found that monitors patients' urine amounts. This research was planned to examine the effect of clean intermittent catheterization training given via mobile application to individuals with spinal cord injury on their quality of life and compliance.
NCT03931408
Participants will undergo daily gentamicin bladder instillations to determine if its use will reduce the rate of symptomatic urinary tract infections (UTIs) as well as the use of oral and intravenous antibiotics in adults with chronic spinal cord injury (SCI) who have recurrent UTIs. Participants are randomized into one of three groups: 1) Gentamicin and saline instillation 2) Saline only instillation 3) Standard of care, no instillation.
NCT06734390
Surgical outcomes of bladder neck surgery in children with neurogenic bladder. Consequences on bladder voiding.
NCT06734429
Retrospective monocentric study of the outcomes of patients with neurogenic bladder who had a urinary artificial sphincter before the age of 18 years old. Hypothesis: what was the impact of the urinary artificial sphincter on the global management of the patient?
NCT06733194
The goal of this observational study is to describe the complications in participants who underwent enterocystoplasty in childhood. The main question\[s\] it aims to answer are: * what kind of complications are there * the kind of complications depending on the type of enterocystoplasty Participants data will be collected in the medical field. There is no comparison group.
NCT00629642
A clinical study to evaluate the efficacy and safety of solifenacin in patients with bladder symptoms due to spinal cord injury or multiple sclerosis
NCT05809154
Lower urinary tract dysfunction (LUTD) is a very common complication of urological, gynecological, neurological, metabolic, inflammatory or tumor disease. LUTD is not an inevitable condition, the investigators can help in many ways. Modern clinical examinations like urodynamics allow for patient tailored treatment strategies. Urodynamics however, even if minimal invasive, may lead to urinary tract infections and are very expensive4. Aim of this study is to evaluate in the long-term perspective what patients profit of urodynamic examinations and in what patients the investigators could resign to perform urodynamics in the future and or in what patients the interval of urodynamics could be extended. Main objective is to follow in a long-term prospective cohort study, patients suffering of lower urinary tract dysfunction (LUTD). In this observational study the investigators will include all patient undergoing clinical routine urodynamic examination to better address what is the normal course of LUTD with and without Treatment. The aim is to have a prospective urodynamics database allowing to answer questions related to urodynamics.
NCT05562713
The purpose of the study is to develop a comprehensive program to increase early initiation of self-catheterization in children with Spina Bifida. This will be a prospective open label randomized control trial. Patients and caregivers/guardians in the intervention arm will be enrolled in a comprehensive program that utilizes behavioral economic theory to incentivize initiation of independent CIC. The study population will be patients aged 4 to 12 years old with diagnosis of spina bifida, including meningocele and myelomeningocele, as defined by International Classification of Diseases, 10th revision (ICD10). This study will look at behavioral interventions. There are no additional physical risks to participation in the study. Patient demographics will be reported using descriptive statistics. Study team will use Kaplan-Meier curves to demonstrate and compare the probability of achieving independent CIC over time between the study arms.