Mirabegron for Female OAB Patients: Comparison of Daytime and Nighttime Dosing
Overactive Bladder SyndromeThe aim of this study is to elucidate whether night-time dosing of mirebegron can improve nocturia, compared with daytime dosing of mirabegron.
Effectiveness of Bilateral PTNS Compared to Unilateral PTNS for the Treatment of Overactive Bladder/Urge...
Overactive Bladder SyndromeUrinary Incontinence1 moreThis 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
Botulinum Toxin A vs Anticholinergic Treatment of Neurogenic Overactive Bladder in Patients With...
Urinary BladderNeurogenic1 moreBotulinum toxin type A injections into the detrusor at a dose of 200 units (U) of BOTOX® are a recognized second-line treatment for the treatment of adult neurogenic lower urinary tract disorders. Anticholinergics are established as the usual first-line treatment for neurogenic detrusor hyperactivity, but are oft not sufficiently effective and have significant side effects. In patients with multiple sclerosis (MS) suffering from overactive bladder, the 200 U dose of BOTOX® is very effective but induces a risk of urinary retention in 30% of patients requiring the temporary use of self-catheterization1. At 100 U, a recent study shows the efficacy and very good tolerance of botulinum toxin A in terms of probing risk in MS patients with overactive bladder and failure of anticholinergics. Furthermore, the efficacy of anticholinergics in MS has been little studied and is also disputed. The investigators plan to test the therapeutic alternative as the first line of treatment in two groups of randomized MS patients from a homogeneous population suffering from overactive bladder: a group testing the effectiveness of low doses of botulinum toxin type A (100 U, BOTOX®), the other group receiving the standard anticholinergic treatment (solifenacin succinate, Vesicare®). During this pilot study, the efficacy and side effects profile of each treatment will be analyzed in order to determine the amplitudes of effect and the safety profiles in this population and in order to establish the statistical hypotheses for a subsequent randomized multicenter study. The aim of this study will be to establish the benefit of botulinum toxin at a dose of 100 U as a first-line treatment instead of anticholinergics
Repetitive Transcranial Magnetic Stimulation in Women With Overactive Bladder With Urgency Incontinence...
Overactive BladderUrge IncontinenceOveractive bladder (OAB) affects an estimated 16-30% of women in the US and urgency urinary incontinence (UUI) affects 7-11% of women with OAB. It is known that repetitive transcranial magnetic stimulation (rTMS) over the supplementary motor area (SMA) can modulate the pelvic floor muscle activity with potential benefits for various urologic conditions. The goal of this study is to assess feasibility of rTMS as a treatment option for OAB with UUI by determining which rTMS frequency is most effective in targeting sensory components of OAB, namely urinary urgency, and also in targeting the brain network known to be involved in OAB.
BTL Emsella Chair Versus Sham for the Treatment of Overactive Bladder
Overactive Bladder SyndromeOveractive Bladder2 moreThe 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.
TEST-ON - Does iStim Reduce Urinary Urgency?
Overactive BladderUrgency-frequency Syndrome1 moreOveractive bladder (OAB) is a chronic disorder with an overall prevalence in the adult population of over 10%, but that may exceed 40% in elderly groups. Most overactive bladder treatments are aimed at decreasing urgency incontinence episodes. The purpose of this study is to determine whether an at-home transvaginal electrical stimulation (TES) program works to alleviate symptoms of urgency in patients with urinary urgency and frequency without incontinence. This is a cross-over trial. Women >18 yo presenting with OAB-dry will be randomized to receive one of two TES at home programs for 4 weeks. After completion of the program, the participant's symptoms will be assessed with standardized patient questionnaires. There will then be a 3 week washout period followed by the second at-home TES program. At the completion of the second program, the participant's symptoms will be assessed with the same standardized questionnaires. The participants will be followed for 6 months following the completion of the TES program.
Acupuncture for Overactive Bladder in Adults
Overactive BladderThe purpose of this study is to assess the effectiveness and safety of acupuncture for treating overactive bladder in adults.
Efficacy and Safety of High Dose Vitamin D Supplementation for Overactive Bladder Dry in Children...
Overactive BladderThis prospective, randomized, 3-arms, parallel-design, controlled clinical trial is conducted to determine whether high dose vitamin D supplementation (combined with standard urotherapy ) improves outcomes, compared with solifenacin (combined with standard urotherapy ) ,and standard urotherapy alone in children with OAB dry.
A Study of Mirabegron in Young Children With Neurogenic Detrusor Overactivity
Neurogenic Detrusor OveractivityPeople with neurogenic detrusor overactivity have poor bladder control because of how their nerves to the bladder are wired. This can cause high pressure in the bladder. It can also cause the bladder to leak by accident (incontinence). In this study, the researchers are studying whether a medicine, mirabegron, can help young children with neurogenic detrusor overactivity. The children will be from 6 months to under 3 years old. Mirabegron has already been approved for adults with bladder problems. The main aim of this study is to learn if mirabegron increases the maximum bladder capacity (to prevent high pressure in the bladder) in young children after 24 weeks of treatment. Maximum bladder capacity is the maximum amount of urine that the bladder can hold before it releases urine or starts to leak. There will be 2 groups in the study. Young children who are not taking certain medicines for their condition will be in group A. Young children who are already taking certain medicines for this condition will be in group B. Children in group B will stop taking these medicines before taking mirabegron. Their treatment will be delayed by 2 weeks to allow the other medicines to be cleared from the body before treatment. Both groups (A and B) will take the same treatment and have the same checks throughout the study. Children will have their vital signs checked (blood pressure, heart rate and body temperature). They will also have an ECG to check their heart rhythm and give urine samples for laboratory tests. Other tests will include checking how the bladder fills and empties plus an ultrasound of the bladder area. The caregivers will be shown how to check their child's blood pressure. They will be given an electronic diary to record the blood pressure, as well as any other medicines taken. They will do this every day for 7 days before each visit. Mirabegron will be stirred into water, making it easier for children to drink. Children will drink mirabegron once a day for up to 52 weeks. They will start on a low dose, adjusted for their weight. If children are taking other medicines for this condition, they will wait an extra 2 weeks before starting mirabegron. At weeks 2, 4 and 8, the dose may be increased once to a higher dose if the study doctor thinks the child will benefit from the higher dose. The children and their caregivers will visit the clinic at 2, 4, 8, 12, 24, 52, and 54 weeks. There will be fewer clinic visits if a child stays on the lower dose of mirabegron. In this case, the clinic will phone the caregiver instead to check the information in the diary. During each visit, the children will have their vital signs checked and have an ECG. The caregiver will be asked if their child has had any medical problems. At some visits, the children will give urine and blood samples for laboratory tests. Other tests will include checking how the bladder fills and empties. 36 weeks after treatment starts, the clinic will phone the caregiver to ask if their child has had any medical problems, and will check the information in the diary. The children and their caregivers will visit the clinic 52 weeks after treatment starts. The caregiver will be asked if their child has had any medical problems. The children will have a physical exam and have their vital signs checked. Also, they will have an ECG and have urine and blood samples taken for laboratory tests. Other tests will include an ultrasound of the bladder area. There will be a final clinic visit at 54 weeks. The caregiver will be asked if their child has had any medical problems. The children will have a physical exam and will have their vital signs checked. They will also have an ECG. The caregiver will be asked to complete a survey on their child's experience with taking mirabegron. They will do this at 4, 24 and 52 weeks after their child starts treatment. Finally, the clinic will phone the caregiver 30 days after the last dose of mirabegron to check if there were any further medical problems. No other visits are planned during this study.
Comparative Effectiveness of Initial OAB Treatment Options Among Older Women at High Risk of Falls...
Urinary BladderOveractive2 moreThe goal of this study is to conduct a randomized pilot multi-arm clinical trial comparing a standard course of physical therapist provided pelvic floor muscle training (PFMT) to pharmacologic therapy for the treatment of urgency urinary incontinence (UUI) or Overactive Bladder (OAB) in older women at high risk of falling. The central hypotheses for this project are i) a randomized pilot multi-arm clinical trial comparing PFMT to drug treatment for UUI or OAB in older women at high risk of falling is feasible; and ii) treatment approach can influence both UI and fall related outcomes in this patient population. The main questions it aims to answer are: 1) Is a multi-arm clinical trial comparing PFMT to drug treatment for UUI or OAB in older women at high risk of falling feasible? and 2) How does treatment approach influence both OAB and fall related outcomes in this patient population? Women (16 per arm) 60 years and older with UUI or OAB who screen positive for high fall risk will be randomized to one of three standard of care treatment arms and followed for six months. The three treatment arms are i) a 12-week structured behaviorally based pelvic floor muscle training (PFMT) intervention administered by physical therapists in the clinic; ii) a 12-week course of the beta-3 agonist, Mirabegron; and iii) a 12-week course of the antimuscarinic, Trospium Chloride. Researchers will compare study feasibility and OAB symptom related outcomes across the three groups to see if a larger clinical trial is warranted.