Central Nervous System Changes Following OnabotulinumtoxinA Injection in the Bladder

NCT ID: NCT03033355

Last Updated: 2025-08-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 12 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2019-03-31

Brief Summary

The purpose of this research study is to evaluate higher neural changes following intra-detrusor injection of Onabotulinumtoxin-A (BTX-A) in patients with Multiple Sclerosis (MS).

We will use our prospectively collected cohort of patients. 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).

Detailed Description

Multiple Sclerosis is a severe debilitating disease that affects patient's 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 and/or 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. Onabotulinumtoxin-A (BTX-A) intra-detrusor 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 perception/localization 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 intra-detrusor 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 intra-detrusor injection of BTX-A with simultaneous urodynamic evaluation.

Clinical correlation between women with these chronic urologic problems and new discoveries at level of central nervous system activity will give a better understanding of this disorder, leading to the development of more effective diagnostic and treatment modalities.

Conditions

Multiple Sclerosis; Lower Urinary Tract Symptoms; Neurogenic Bladder; Detrusor, Overactive; Urge Incontinence

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Pre and post BTX-A injection

Female patients with confirmed diagnosis of Multiple Sclerosis referred to our Neuro-urology clinic with neurogenic lower urinary tract dysfunction receiving intra-detrusor injection of onabotulinumtoxin-A.

Intra-detrusor injection of Onabotulinumtoxin-A

Intervention Type: DRUG

Using cystoscopy, Onabotulinumtoxin-A is injected into the bladder.

Interventions

Intra-detrusor injection of Onabotulinumtoxin-A

Using cystoscopy, Onabotulinumtoxin-A is injected into the bladder.

Intervention Type: DRUG

Other Intervention Names

OnabotulinumtoxinA, Botox®

Eligibility Criteria

Inclusion Criteria

• Patients with clinical diagnosis of neurogenic bladder.
• History of any neurologic illness or injury (including but not limited to spinal cord injury, Multiple Sclerosis, spina bifida, Parkinson's, major spine surgery).
• 18 years or older.
• Female patients.

Exclusion Criteria

• Male
• History of any incontinence surgery (sling, Marshall-Marchetti-Krantz Procedure, Burch).
• History of any lower urinary tract surgery or manipulation (urethral dilation).
• Positive urine pregnancy test at enrollment .

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The Methodist Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Rose Khavari, M.D.

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rose Khavari, MD

Role: PRINCIPAL_INVESTIGATOR

The Methodist Hospital Research Institute

Locations

Houston Methodist Hospital

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Pro00010110

Identifier Type: -

Identifier Source: org_study_id