Central Nervous System Changes Following OnabotulinumtoxinA Injection in the Bladder

NCT03033355 | Completed Results FDA Drug

• 1 other identifier: Pro00010110
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

Neurogenic Bladder, Detrusor Overactivity, Botox, fMRI

Outcome Measures

Primary Outcomes (1)

• Change in Blood Oxygen Level Dependent (BOLD) Signals in the Brain After Treatment

  Brain activation patterns associated with the strong desire to void (Full Urge) were examined using functional magnetic resonance imaging (fMRI), assessing BOLD signal intensity in predefined regions of interest at baseline and 6-10 weeks following OnabotulinumtoxinA (OnabotA) injection. Post-treatment changes in activity (voxel signal) were analyzed based on a statistical threshold, with increased activation defined by a T-value greater than or equal to 2.0 and decreased activation by a T-value less than or equal to 2.0.

  Baseline (pre-OnabotA) and 6-10 weeks post-OnabotA treatment

Secondary Outcomes (6)

• Changes in Urodynamic (UDS) Parameters Following OnabotA Treatment

  Baseline (Pre-OnabotA) and 6-10 Weeks Post-OnabotA Treatment

• Number of Participants Presenting With Neurogenic Detrusor Overactivity (NDO) Events During Urodynamic Studies (UDS) Before and After OnabotA Treatment

  Baseline (Pre-OnabotA) and 6-10 Weeks Post-OnabotA Treatment

• Changes in Subjective Clinical Outcomes Following Treatment - Urogenital Distress Inventory, Short Form (UDI-6)

  Baseline (Pre-OnabotA) and 6-10 Weeks Post-OnabotA Treatment

• Changes in Subjective Clinical Outcomes Following Treatment - Incontinence Impact Questionnaire Short Form (IIQ-7)

  Baseline (Pre-OnabotA) and 6-10 Weeks Post-OnabotA Treatment

• Changes in Voiding Diary Metrics - Urge Urinary Incontinence (UUI) Events Per Day

  Baseline (Pre-OnabotA) and 6-10 Weeks Post-OnabotA Treatment

Study Arms (1)

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.

Drug: Intra-detrusor injection of Onabotulinumtoxin-A

Interventions

Intra-detrusor injection of Onabotulinumtoxin-A DRUG

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

Also known as: OnabotulinumtoxinA, Botox®

Pre and post BTX-A injection

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female subjects diagnosed with Multiple Sclerosis and lower urinary tract symptoms who are refractory to conservative management for neurogenic detrusor overactivity.

You may qualify if:

• 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).
• years or older.
• Female patients.

You may not qualify if:

• 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 .

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead

Study Sites (1)

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

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

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Incontinence; Urination Disorders

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Results Point of Contact

• Title: Dr. Rose Khavari
• Organization: houston methodist Hospital

rkhavari@houstonmethodist.org

713-363-9154

Study Officials

• Rose Khavari, MD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 15, 2016
• First Posted: January 26, 2017
• Study Start: February 1, 2014
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: August 5, 2025
• Results First Posted: August 5, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)