Urinary Bladder, Neurogenic Clinical Trial
Official title:
A Double Blind, Randomized Placebo Controlled Trial Evaluating the Urodynamic and Clinical Efficacy of Mirabegron Among Neurogenic Bladder Patients
The proposed study is a randomized, double blind placebo controlled multicenter study to
determine the effectiveness of mirabegron in the treatment of neurogenic bladder dysfunction.
Patients will be randomized into one of two trial arms: mirabegron 25mg for two weeks, with
escalation to 50mg for the remaining 8 weeks, or matched placebo capsule for two weeks, with
placebo escalation for the remaining 8 weeks. Each of these trial arms will be stratified
based on whether the patient is already taking an anticholinergic medication or not. The
study will treat a total of 144 patients (72 with placebo, 72 with mirabegron). The study
hypothesis is that mirabegron will result in a statistically superior (increased) urodynamic
bladder capacity.
The study duration is 12 weeks, with a 1-4 week run in period where no active or placebo
treatment will be administered. The primary outcome measure will be based on an increase in
urodynamic bladder capacity. Secondary outcome measures will be additional urodynamic
parameters, urinary symptom scales, urinary quality of life indices, and voiding diary
results.
Patients who are over 18 years of age with a diagnosis of multiple sclerosis (MS) or spinal
cord injury (SCI) will be eligible to participate. All eligible patients will have urodynamic
studies performed within 4 weeks of trial enrollment, and at the end of study (week 9-10).
Adverse events and study outcomes will be assessed at predefined study time points.
n/a
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05141487 -
Feasibility of Triggered Sacral Neuromodulation for Neurogenic Bladder
|
||
Completed |
NCT01920243 -
Evaluation of a Bowel and Bladder Health Management Program for Individuals With Spinal Cord Injury (SCI)
|
N/A | |
Completed |
NCT04528784 -
Feasibility Study of Transcutaneous Tibial Nerve Stimulation for Urinary Symptoms in People With Multiple Sclerosis
|
N/A | |
Enrolling by invitation |
NCT03336424 -
Urinary Disorders in Patients With Multiple Sclerosis: Invasive Vs Non-invasive Investigations.
|
N/A | |
Not yet recruiting |
NCT05075642 -
Multicenter Observational Study for the Evaluation in Clinical Practice of Urinary Disorders in Multiple Sclerosis
|
||
Completed |
NCT02600715 -
Reduction of Bladder Injection Pain With Belladonna Opiate Suppository
|
Phase 4 | |
Recruiting |
NCT04128709 -
Measurement of Bladder Pressure With a Novel External Device (Cystomanometer) - Home Use
|
N/A | |
Enrolling by invitation |
NCT05740527 -
Ambulatory Closed-loop Stimulation for Bladder Control
|
N/A | |
Completed |
NCT02501928 -
Open-label Long-term Extension Study of Fesoterodine in Japanese Subjects With Neurogenic Detrusor Overactivity.
|
Phase 3 | |
Recruiting |
NCT06336304 -
NXT Post-Market Clinical Follow-up
|
||
Completed |
NCT06445426 -
Cystometry Using a Novel Microsensor System in Patients With Neurogenic Bladder Dysfunction
|
||
Recruiting |
NCT04819360 -
Botulinum Toxin A vs Anticholinergic Treatment of Neurogenic Overactive Bladder in Patients With Multiple Sclerosis
|
Phase 4 | |
Completed |
NCT01557244 -
A Study To Find Out How Fesoterodine Works In Children Aged 6 To 17 Years With Bladder Overactivity Caused By A Neurological Condition
|
Phase 3 | |
Recruiting |
NCT05380661 -
Heart Rate Variability and Anxiety During Urinary Bladder Catheterization
|
N/A | |
Recruiting |
NCT04193709 -
Recovery of Bladder and Sexual Function After Human Spinal Cord Injury
|
N/A | |
Completed |
NCT02582151 -
Transcutaneous Peripheral Neuromodulation for Neurogenic Bladder
|
N/A | |
Active, not recruiting |
NCT05232253 -
Cystoealstometer (Bladder Monitor Device)-Home Use
|
N/A | |
Completed |
NCT03405285 -
Connected Catheter Clinical Feasibility Study( CFS)
|
N/A | |
Completed |
NCT02673047 -
Observational Study of Botulinum Toxin Type A in Patients With Urinary Incontinence Associated With Overactive Bladder
|
N/A | |
Completed |
NCT01773213 -
Detrusor Contraction During the Ice-water-test
|
N/A |