Ignite Creation Date:
2024-05-06 @ 9:38 AM
Last Modification Date:
2024-10-26 @ 12:17 PM
Study NCT ID:
NCT03033355
Status:
COMPLETED
Last Update Posted:
2020-03-25
First Post:
2016-07-15
Brief Title:
Central Nervous System Changes Following BotulinumtoxinA Injection in the Bladder
Sponsor:
Rose Khavari MD
Organization:
The Methodist Hospital Research Institute
Study Overview
Official Title:
A Prospective Study of Higher Neural Control Changes Following Intradetrusor Injection of BotulinumtoxinA in Patients With Multiple Sclerosis and Lower Urinary Tract Symptoms
Status:
COMPLETED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this prospective research study is to evaluate higher neural changes following intradetrusor injection of Botulinum toxin-A BTX-A in patients with Multiple Sclerosis MS Concurrent Urodynamic and Functional Magnetic Resonance fMRI data will be recorded pre- and post- intravesical injection of BTX-A in patients with Multiple Sclerosis MS and neurogenic detrusor activity NDO
Other objectives are to evaluate the role of urinary biomarkers such as brain-derived neurotropic factor BDNF and nerve growth factor NGF associated with bladder overactivity and to determine whether the common validated urgency questionnaires correlate with fMRI findings and urinary biomarker concentration pre- and post- BTX-A injection in patients with MS and NDO
Other objectives are to evaluate the role of urinary biomarkers such as brain-derived neurotropic factor BDNF and nerve growth factor NGF associated with bladder overactivity and to determine whether the common validated urgency questionnaires correlate with fMRI findings and urinary biomarker concentration pre- and post- BTX-A injection in patients with MS and NDO
Detailed Description:
Multiple Sclerosis is a severe debilitating disease that affects patients quality of life Up to 90 of patients with MS will develop lower urinary tract dysfunction within the first 18 years of the disease Lower urinary tract symptoms LUTS can range from urgency to urge urinary incontinence andor hesitancy and incomplete bladder emptying Urgency frequency and neurogenic detrusor overactivity NDO are the most common urologic findings 34-99 during diagnostic evaluations of patients with MS Even though anticholinergic or beta agonist drugs have limited effectiveness and adverse side effects they are the first line pharmacotherapy for patients with NDO if behavioral modifications and pelvic floor physical therapy are unsuccessful Botulinum toxin-A BTX-A intradetrusor injection is a highly effective treatment option for patients with NDO who are refractory to more conservative management BTX-A blocks the release of acetylcholine at the neuromuscular junction and leads to a temporary chemodenervation of the bladder paralysis of the muscle Motor effects of BTX-A on the bladder have been extensively studied and widely reported in the literature and the US Food and Drug Administration has approved BTX-A for the treatment of detrusor overactivity in neurogenic and non-neurogenic patients However the sensory effects of BTX-A injection correlating to central nervous system regional perceptionlocalization of urgency frequency and urge incontinence in humans are not well known
Over the past decades functional MRI fMRI has been used to study the activation of supraspinal lower urinary tract control centers in healthy subjects during the storage and voiding phases Given these facts the investigators are interested in evaluating the role of intradetrusor injection of BTX-A in afferent response in patients with MS and NDO High-resolution neuroimaging techniques will help investigators to further understand how MS affects the bladder-brain controls This study will use fMRI and task-related blood oxygen level dependent BOLD signal to evaluate patients with MS and NDO prior to and 6-10 weeks after intradetrusor injection of BTX-A with simultaneous urodynamic evaluation
Clinical correlation between women with these chronic urologic problems and new discoveries at level of CNS activity will give a better understanding of this disorder leading to the development of more effective diagnostic and treatment modalities
Over the past decades functional MRI fMRI has been used to study the activation of supraspinal lower urinary tract control centers in healthy subjects during the storage and voiding phases Given these facts the investigators are interested in evaluating the role of intradetrusor injection of BTX-A in afferent response in patients with MS and NDO High-resolution neuroimaging techniques will help investigators to further understand how MS affects the bladder-brain controls This study will use fMRI and task-related blood oxygen level dependent BOLD signal to evaluate patients with MS and NDO prior to and 6-10 weeks after intradetrusor injection of BTX-A with simultaneous urodynamic evaluation
Clinical correlation between women with these chronic urologic problems and new discoveries at level of CNS activity will give a better understanding of this disorder leading to the development of more effective diagnostic and treatment modalities
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None