NCT06059066

Optimization of OnabotulinumtoxinA (BTX-A) Injection for the Treatment of Neurogenic Lower Urinary Tract Dysfunction

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: The Methodist Hospital Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 of neurogenic lower urinary tract dysfunction (NLUTD), which develops when either the detrusor muscle fails to maintain effective contractions (voiding phase) or fails to relax appropriately with low pressures (storage phase), if the urethral sphincter (internal or external) fails to lower its tonicity and resistance, or if there is an asynchrony in events eventually leading to detrusor sphincter dyssynergia (DSD). Different patterns of NLUTD (including both storage and voiding) can arise depending on the level of injury or type of neurological disease. It can be characterized by urinary urgency, frequency and incontinence or urinary hesitancy and retention that leads to urinary tract infections (UTIs). Some patients develop neurogenic overactive bladder (NOAB). Management of NOAB symptoms is complex. Treatment with BTX-A has been shown to decrease episodes of urinary incontinence and improve quality of life in this population. It has also been shown to ameliorate a multitude of devastating complications, such as upper tract deterioration, recurrent urinary tract infections, sepsis, and death. According to the current manufacturer's recommendation, a standard 200-unit vial of Botox® should be diluted in 30cc of 0.9% saline and injected across 30 different sites in the detrusor muscle (Figure 2). Despite these guidelines, there are wide variations in administration techniques, raising the question what is the best depth and location for injection, and optimal concentration and volume of toxin per injection site. The objective of this study is to determine the optimal injection schema for 200 units or more of intradetrusor BTX-A in patients with NOAB in the office setting. The investigators hypothesize that patients with NOAB symptoms undergoing intradetrusor injection of 200 units (or more) of BTX-A will be more willing to pursue additional sessions of BTX-A injections with a protocol utilizing less injection sites, while still maintaining effectiveness of the procedure.

Conditions

• Neurogenic Bladder
• Lower Urinary Tract Symptoms
• Overactive Bladder
• Neuro: Neurogenic Bladder
• Neurogenic Detrusor Overactivity

Interventions

Type	Name	Description
PROCEDURE	Standard number of injection sites	200 units or 300 units BTX-A reconstituted in 20 mL normal saline, injected into the bladder detrusor in 20 separate injections of 1 mL including the trigone.
PROCEDURE	Reduced number of injection sites	200 units or 300 units BTX-A reconstituted in 5 mL normal saline, injected into the bladder detrusor in 5 separate injections of 1 mL including the trigone.

Timeline

• Start date: 2023-10-04
• Primary completion: 2024-04-30
• Completion: 2024-04-30
• First posted: 2023-09-28
• Last updated: 2025-05-09
• Results posted: 2025-05-09

Locations

1 site across 1 country: United States