View clinical trials related to Neurogenic Detrusor Overactivity.
Filter by:The purpose of this study is to evaluate and standardize the way providers perform OnabotulinumtoxinA (BTX-A) injections into the bladder for the diagnosis of neurogenic lower urinary tract dysfunction (NLUTD)/overactive bladder (OAB). NLUTD/OAB is a syndrome that affects many people, and includes urinary frequency, urinary urgency, urgency incontinence, and nocturia. This syndrome can be challenging to treat and often requires procedural management - including BTX-A injections into the bladder.
People 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.
Following spinal cord injury signals between the brain and the bladder are disrupted. As a result the bladder often becomes overactive which can lead to the need for frequent trips to the toilet, regular incontinence episodes and a decreased quality-of-life. Neuromodulation is a therapy that aims to target the nerves that become overactive controlling the bladder, stopping the bladder overactivity on demand using an external (non-invasive) nerve stimulation box and sticker electrodes placed on the penis or clitoris. This study is a pilot study that aims to investigate neuromodulation for improving symptoms of bladder overactivity when used by 10 people over eight weeks at home. We will assess whether using the device improves bladder capacity, incontinence, frequency of needing the toilet and whether there are any longer lasting changes after 8 weeks. Finally, the study will aim to find out the acceptability of using this type of therapy for participants and the acceptability of the device we are using. Participants in this trial will participate over 13 weeks and need to visit our centre in Stanmore to have urodynamics tests in the 1st, 9th and 13th week. At home they will use a small stimulation device on a daily basis for 8 weeks to control overactivity in the bladder. Whilst at home they will record relevant outcomes in several three-day diaries and questionnaires. They will record baseline data before starting stimulation and for 4 weeks after.
The purpose of this study is to evaluate the safety, efficacy, and PK of vibegron in pediatric participants with NDO who are regularly using CIC
Fesoterodine (Toviaz™) extended-release (ER) tablets are currently manufactured by Aesica Pharmaceuticals, Zwickau, Germany (Zwickau). An additional manufacturing location at Pfizer Freiburg, Germany (Freiburg) has been identified. This pivotal bioequivalence (BE) study is being conducted to satisfy the United States (US) Food and Drug Administration (FDA) regulatory requirements for the qualification of the Freiburg manufacturing site. Overall Study Design This is an open-label, randomized, single-dose, 4-period, 4-treatment, 2-sequence, two 2-way crossover study in healthy participants. This study will assess the BE of Fesoterodine (Toviaz™) 4 mg and 8 mg ER tablets manufactured at Zwickau (Reference) versus Freiburg (Test). Study participants will include healthy male and/or female individuals between the ages of 18 and 55 years, inclusive. Approximately 18 participants who fulfill entry criteria will be randomized to 1 of the 2 treatment sequences as shown in the table below.
Open Label, Single-Dose, Crossover Study To Assess The Bioequivalence Under Fed And Fasted Conditions Of The Fesoterodine Beads-In-Capsule (BIC) SR4 And SR7 Formulations And To Estimate The Bioavailability of SR7 Beads Sprinkled On Apple Sauce Relative To The Beads-In-Capsule SR7 Formulation Administered Intact.
Study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of Rec 0/0438 in subjects with neurogenic detrusor overactivity due to spinal cord injury
The purpose of this study is to determine if TAR-302-5018, an investigational drug-delivery system, is safe and tolerable in patients with neurogenic detrusor overactivity (NDO) resulting from spinal cord injury (SCI).
The objective of the study was to evaluate the efficacy, safety, tolerability and pharmacokinetics of mirabegron after multiple-dose administration in the pediatric population.
The purpose of the study is to evaluate the pharmacokinetics (PK) of mirabegron oral suspension after single dose administration in children with neurogenic detrusor overactivity (NDO) or overactive bladder (OAB). This study will also evaluate the safety and tolerability as well as the acceptability and palatability of mirabegron oral suspension after single dose administration in children with NDO or OAB.