N/A
N=78
Optimization of OnabotulinumtoxinA (BTX-A) Injection for the Treatment of Neurogenic Lower Urinary Tract Dysfunction
Neurogenic Bladder · Lower Urinary Tract Symptoms · Overactive Bladder · Neuro: Neurogenic Bladder · Neurogenic Detrusor Overactivity
Bottom Line
View on ClinicalTrials.gov: NCT06059066 ↗Enrolled (actual)
78
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Willingness to Repeat Procedure — 9.16; 9.34; 9.73; 9.67 units on a scale — p=0.57
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Standard number of injection sites (Procedure); Reduced number of injection sites (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Methodist Hospital Research Institute
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Willingness to Repeat Procedure |
9.16; 9.34; 9.73; 9.67 | 0.57 |
| SECONDARY Change in Neurogenic Bladder Symptoms After BTX-A Treatment - International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) |
-4.11; -5.23; -2.33; -3.54 | 0.59 |
| SECONDARY Change in Neurogenic Bladder Symptoms After BTX-A Treatment - Neurogenic Bladder Symptom Score - Short Form (NBSS-SF) |
5.44; 4.65; -1.81; -2.15; -2.93; -2.15 | 0.57 |
| SECONDARY Patient Impression of Clinical Improvement After BTX-A - Patient Global Impression of Improvement (PGI-I) Scale |
5.26; 4.88 | 0.21 |
| SECONDARY Patient Reported Procedural Discomfort - Numeric Pain Rating Scale (NPRS) |
3.39; 0.57 | <0.00002 sig |
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 dysfunction (NLUTD)/overactive bladder (OAB). NLUTD/OAB is a syndrome that affects many people, and includes urinary frequency, urinary urgency, urgency incontinence, and nocturia. This syndrome can be challenging to treat and often requires procedural management - including BTX-A injections into the bladder.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT06059066). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.