Status:
COMPLETED
Optimization of OnabotulinumtoxinA (BTX-A) Injection for the Treatment of Neurogenic Lower Urinary Tract Dysfunction
Lead Sponsor:
The Methodist Hospital Research Institute
Collaborating Sponsors:
Collaborating for Advancement of Interdisciplinary Research in Benign Urology
Conditions:
Neurogenic Bladder
Lower Urinary Tract Symptoms
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 dysfunctio...
Detailed Description
Neurological disorders such as Multiple Sclerosis (MS), Spinal Cord Injury (SCI), Parkinson's Disease (PD), Spina Bifida (SB), and stroke disrupt neural control of voiding and lead to the development ...
Eligibility Criteria
Inclusion
- Adult men and women (\>18 years of age) with a diagnosis of neurological conditions such as MS, PD, CVA, myelomeningocele, SCI, or traumatic brain injury longer than 6 months prior to treatment.
- Diagnosis of neurogenic bladder indicated for treatment with BTX-A for OAB symptoms.
- Participants must be able to provide informed consent, as well as understand and be willing to undergo.
- follow-up procedures and completion of all questionnaires provided during the study.
Exclusion
- Symptomatic UTI at the time of procedure, defined as positive nitrites or high-volume leukocyte esterase on urine dip in addition to at least one of the following symptoms: dysuria, gross hematuria, suprapubic pain, frequency/urgency above baseline.
- Diagnosis of bladder pain syndrome or other chronic pain syndrome including fibromyalgia, chronic pelvic pain, pelvic floor dysfunction, levator myalgia.
- Untreated bladder malignancy.
- Women who are currently pregnant or breast feeding.
- Contraindications to intradetrusor BTX-A injections.
Key Trial Info
Start Date :
October 4 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2024
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT06059066
Start Date
October 4 2023
End Date
April 30 2024
Last Update
May 9 2025
Active Locations (1)
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1
Houston Methodist Hospital
Houston, Texas, United States, 77030