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NCT04873037
The purpose of this clinical trial is to compare the Emsella Chair therapy to Sham and to determine whether electromagnetic technology is effective in the treatment of overactive bladder (OAB). Currently there are no other studies utilizing the Emsella Chair for the treatment of OAB. Eligible subjects will receive 2 treatments per week for a total of 4 weeks.
NCT06769854
The purpose of this study is to find out if overactive bladder (OAB) can be safely treated by stimulating a nerve near the ankle. This procedure is called percutaneous tibial nerve stimulation (PTNS). It will be done by a device called the Urgent PC. The Urgent PC works by sending weak electrical signals through a thin needle to the nerve near the ankle. Stimulating this nerve may change bladder control.
NCT03535857
This study is designed to evaluate whether bilateral Posterior Tibial Nerve Stimulation is more effective than unilateral Posterior Tibial Nerve Stimulation at treating overactive bladder and urge urinary incontinence
NCT06198439
Overactive bladder (OAB) imposes a significant quality of life, mental health, and economic burdens. OAB with or without Urgency incontinence is associated with depression, sexual dysfunction, and limitation of social interactions and physical activities, which significantly affects quality of life. Non-invasive neuromodulation with repetitive transcranial magnetic stimulation (rTMS) can be used in research settings to investigate responses to focal regional brain activation. In the clinical setting, rTMS normalizes brain activity with associated clinical benefits in conditions such as refractory depression. rTMS has been studied for effects on lower urinary tract symptoms (LUTS) in bladder pain and neurogenic lower urinary tract symptoms (LUTS) populations. Unlike many standard of care OAB interventions, the safety of rTMS is well-reported, including for use in elderly populations and those with cognitive impairment. Functional magnetic resonance imaging (fMRI) to evaluate neuroplasticity is emerging as an essential tool to define OAB phenotypes; however, phenotyping studies guided by mechanistic data are lacking. The effects of central neuromodulation on regions involved OAB mechanisms and associated physiological and clinical responses are unknown. This study will be the first to report neuroplasticity, physiologic, and clinical effects of central neuromodulation with rTMS in adults with OAB.
NCT06616675
In this study the investigators compare the parasacral transcutaneous electric nerve stimulation (PTENS) treatment with Darifenacin to improve OAB symptoms in patients infected with HTLV-1.
NCT05719285
The goal of this clinical trial is to evaluate the outcomes of differing durations of antibiotic prophylaxis with bladder onabotulinumtoxinA injection in patients with refractory overactive bladder. The main question it aims to answer are: • Is the incidence of post-procedure UTI similar between single-dose and multi-day durations of peri-procedural antibiotics? Participants will be randomized to single-dose versus multi-day dose of antibiotic prophylaxis with bladder onabotulinumtoxinA injection. Researchers will compare incidence of UTI in each group to see if there is a significant difference.
NCT06123364
The goal of this clinical trial is to learn about impact of extracorporeal electromagnetic stimulation in addition to medical treatment with mirabegron on the treatment of overactive bladder (OAB). The study will include female patients, aged between 30 and 80, with signs of OAB, including urinary frequency, urgency and urinary urgency incontinence. The main questions it aims to answer are: * Does the addition of extracorporeal electromagnetic stimulation to medical treatment with mirabegron influence the urinary urgency incontinent or frequency? * Does the addition of extracorporeal electromagnetic stimulation to medical treatment with mirabegron influence the urine flow or post-void residual volume? * Does the addition of extracorporeal electromagnetic stimulation to medical treatment with mirabegron influence the patients' quality of life. Participants will: * receive 50 mg of mirabegron daily in the form of tablets, which is used to treat OAB according to current treatment guidelines. * Twice a week receive extracorporeal electromagnetic stimulation in the duration of 20 minutes. The patients will be divided into 2 groups, namely one group will receive actual electromagnetic stimulation, and the other group will receive placebo stimulation. * Have a urogynecological examination, with ultrasound measurements of the remaining urine in the bladder and determination of the thickness of the bladder wall, as well as a uroflow examination, after 4 and 8 weeks of treatment. * Have to to submit urine for laboratory tests and to fill out questionnaires regarding participants' symptoms, after 4 and 8 weeks of treatment. Researchers will compare both study groups to see if the addition of extracorporeal electromagnetic stimulation has influence on the research questions stated above.
NCT04300400
Idiopathic overactive bladder syndrome (iOAB) is a prevalent condition in urological practice. The variability in management between specialists and between centers remains high. Even guidelines are not always clear on the treatment management of drug therapy resistant OAB. Standardization in OAB treatment is needed.
NCT05151081
Purpose: A lot of etiological factors related to overactive bladder (OAB) has been investigated. However, the role of primary nocturnal enuresis (NE), which is characterized with childhood night time incontinence, in the etiology of OAB is controversial. This study aims to evaluate the effect of NE in patients diagnosed with OAB. Metod Between january-september 2021, the data of patients who applied to the urology outpatientclinic with OAB symptoms were collected. Patients with a history of chronic systemic disease, previous medical treatment for OAB and who did not accept to join the study were excluded. According to the diagnosis of childhood NE, patients were divided into two groups. Demographic data hav been recorded. Frequency of incontinence, number of day time void and nocturia were evaluated according to a 3 day voiding diary. Inaddition, max. Urinary flowr atio (Qmax), bladder Wall thickness and postvoid residual volüme rates were determined using uroflowmetry and pelvic ultrasound.
NCT05094414
Interstitial cystitis/bladder pain syndrome (IC/BPS) is a collective term referring to disorders which is characterized by lower urinary tract symptoms, including bladder pain/discomfort, frequent urination without evidence of bacterial infection. The etiology of IC/BPS is still uncertain, and most current treatment for IC/BPS are only symptoms control. Our previous study revealed Epstein-Barr virus (EBV) infection presented in the IC/BPS bladders and involved the pathogenesis. Hence, using anti-viral medication valacyclovir for the patients with IC/BPS might have clinical efficacy.
NCT05069376
This is a prospective randomized clinical trial, evaluating the effect of the intra-ureteral placement of the stent's distal end versus the conventional stent placement on the postoperative LUTS and pain.
NCT03758235
The aim of the original study was to compare Incobot/A versus Onabot/A in order to evaluate if the differences in the pharmacologic formulations between the two drugs could affect their efficacy and safety in the treatment of neurogenic overactive bladder (OAB). In the original study protocol two different dosages for either Incobot/A and Onabot/A (200 U and 100 U) were considered, to treat patients with neurogenic detrusor overactivity incontinence performing intermittent catheterization (IC) with higher dosages and those able to void spontaneously with lower dosage, with the resulting four treatment groups. For such a study, a very large sample of participants should have been treated and followed up, to have adequate power to demonstrate the hypothesis. At the end of last February 2020, we had to temporarily stop all the clinical activities related to the study and patients' recruitment, due to the occurrence of Sars-Cov-2 pandemic in our Country. At that point, a non-inferiority study seemed to be possible and adequate, and we adapted the protocol accordingly. In addition, on the basis of previously published information, we could hypothesize that the new drug (Incobot/A) would have had at least a roughly similar effect to the control drug (Onabot/A). In order to perform a non-inferiority study, the power and sample size analysis have been re-planned. Thus, we perform a not planned interim analysis to show the preliminary results of an ongoing, non-inferiority trial in which patients' recruitment temporarily stopped due to incontrollable external factors. The present study will be aimed to assess the non-inferiority of Incobot/A compared to Onabot/A on the efficacy and safety parameters, in the treatment of patients with refractory NDOI performing IC, who are randomized to receive 200 U of Incobot/A or Onabot/A intradetrusor injections and who are followed up to 12 wks after treatment
NCT03486639
Urodynamic examination evaluates storage and empting phases of the urinary bladder. It enables the clinician to correlate physiologic findings to patients' complains. The data gathered during the examination divided to storage and empting. During the storage phase, bladder sensation is measured while the bladder is filled with sterile water. During years of practice, we noticed that early sensation (bladder over-sensitivity) is occasionally associated with bladder outlet obstruction (as demonstrated in the emptying phase of the examination.
NCT03435991
Rationale: The overactive bladder syndrome is diagnosed clinically by using the ICS criteria of ≥8 micturitions and at least 1 urgency episode per 24 hours. To determine whether patients fit the criteria, micturition diaries ('sensation-related bladder diaries') and other symptom questionnaires with considerable limitations are used. This makes it difficult to get a good impression of the fluctuation of complaints during the day / week. These limitations are overcome using the Experience Sampling Method (ESM). This is an electronic questioning method which is characterized by repeated and random, momentary assessments in the subject's current environment and state. This study follows other successful ESM studies done within the Gastroenterology and Psychiatry Department. The aim of this study is to evaluate if the ESM is more accurate in the assessment of urological complaints in OAB compared to the current assessment with the use of the sensations-related bladder diaries (SR-BDs) and retrospective questionnaires. Furthermore the aim is to assess the reliability and validity of this OAB-specific electronic patient-reported outcome measure (ePRO), based on the Experience Sampling Method-principle, for symptom assessment and assessment of triggers for symptoms in OAB. Objective: To evaluate the accuracy of the ESM to assess urological complaints in OAB compared to SR-BDs and retrospective questionnaires. To assess content validity, reliability and the accuracy to validate the developed ePRO in OAB patients. Study design: The ESM study is a multicentre, prospective, cross-sectional study. Study population: 66 OAB patients will be recruited at the outpatient Pelvic Care Centre in Maastricht UMC+, Zuyderland Hospital and University Hospital Antwerp, 66 healthy volunteers will be recruited as well. Methods: In a period of 7 days, participants will fill out an electronic ESM assessment at 10 random moments during the day. Moreover, they will fill out a sensation-related bladder diary (SR-BD) during the last three consecutive days of filling out the ESM and several symptom questionnaires at the end of the study period. Main study endpoints: The main study outcome comprehends the psychometric properties of the PROM for symptom assessment of OAB symptoms. Secondary outcomes are increase in ESM score for OAB symptoms and environmental and psychosocial factors (e.g. as measured by the PROM) from one time point (t-1) to the next (t).
NCT03695822
We will get the impact of mirabegron on psychological distress, urethra and bladder blood flow and c reactive protein.
NCT03536494
This study was a multicentre, quasi-experimental design, controlled, before-and-after trial to estimate the effectiveness related to the review of mirabegron use and, if appropriate, its discontinuation. Intervention group: Patients with mirabegron prescription assigned to any of the 17 primary health care centers (PHC) located in the northern area of Barcelona. Control group: All the other patients assigned to any of the other 34 health care centers in Barcelona belonging to the Catalan Institut of Health (CIH). The structured intervention included initiatives with general practitioners and urologists/gynaecologists, management support from health care authorities, and monthly feed-back monitoring to general practitioners (GPs). The follow-up period was 12 months, from January 1st to December 31st, 2017.
NCT01559623
The purpose of this study is to assess the prevalence of mycoplasma hominis, ureaplasma urealyticum, neisseria gonorrhea, and chlamydia trachomatis in women with overactive bladder symptoms, and to correlate these findings with cystoscopic and urodynamic findings.
NCT01042119
The neurotoxin Botox (botulinum neurotoxin type A) is shown to be effective in the treatment of therapy refractory overactive bladder syndrome. Our data suggests a longer during efficacy than known from the use in striated muscle. The aim of our study is to analyze short- and longterm efficacy after Botox treatment and to evaluate risk factors for non-responders and side effects such as urinary retention.
NCT00839969
Urethral dilatation is a commonly undertaken intervention for a variety of urinary complaints including overactive bladder symptoms. There is however very little evidence for its efficacy, and no randomized trial evidence. The aim of this study is to ascertain the effect of urethral dilatation on overactive bladder symptoms and on voiding parameters. The null hypothesis is that there will be no difference in symptoms or voiding parameters between the urethral dilatation and sham groups. Eligible women will be assessed initially with a history and examination, a King's Health Questionnaire and Bristol Female Urinary Tract Symptoms (BFLUTS) questionnaire and pressure flow studies. They will be randomized to undergo either cystoscopy alone or cystoscopy and urethral dilatation. Patients will be blinded to the procedure undertaken and randomized using a series of opaque envelopes. Follow up will be at 6 weeks with repeat questionnaires and pressure flow studies. Subjective and objective outcomes will be compared between the two groups.
NCT00220363
The trial consisted of a 2 week Run-In period, 12 week double-blind Treatment period and 2 week Safety Follow-Up period. Subjects were randomized to one of 4 treatment arms receiving either fesoterodine (SPM 907) 4mg, fesoterodine 8mg, active control (tolterodine SR 4mg) or placebo during the Double-Blind Treatment Period. Two primary efficacy variables will be assessed for submission in the United States: change in the average number of micturitions (frequency) per 24 hours and the change in the average number of urge incontinence episodes per 24 hours. For the submissions in the European Union, the first primary variable will be the change in the average number of micturitions (frequency) per 24 hours and the co-primary variable is the treatment response, based on a treatment benefit scale. All continuous variables will be measured as changes from baseline to value after 12 weeks of treatment. The most important safety variables included the assessment of adverse events, laboratory parameters, changes in ECG, physical exams and measurement of residual urine.