Standard Injections Versus Reduced Injections for Intravesical onabotulinumtoxinA Treatment of Overactive Bladder

Overactive Bladder Clinical Trial

Official title: Standard Injections Versus Reduced Injections for Intravesical onabotulinumtoxinA for Treatment of Idiopathic and Neurogenic Overactive Bladder: a Randomized Trial

Status Recruiting

Clinical Trial Summary

OnabotulinumtoxinA is an effective treatment for both idiopathic and neurogenic overactive bladder and was FDA approved for this indication in 2013. The standard technique for injecting onabotulinumtoxinA into the detrusor is mixing 100 units of onabotulinumtoxinA into 10mL of injectable normal saline and injecting 20 sites with 0.5mL in the posterior wall of hte bladder for idiopathic overactive bladder and mixing 200 units into 30mL and injecting 30 sites with 1mL for neurogenic overactive bladder. The purpose of this study is to compare the efficacy of a technique using a reduced number of injections with the same dosage of onabotulinumtoxinA to the standard technique. The hypothesis is that the reduced technique will not be inferior in terms of efficacy as the standard technique and that there will be a lower incidence of urinary tract infections and urinary retention requiring catheterization post-procedure.

Clinical Trial Description

Overactive bladder has a large economic burden within the United States and internationally. Patients are often non-compliant with first and second line treatments for overactive bladder or find that they do not significantly improve symptoms. Intradetrusor onabotulinumtoxinA injection has been showed in many studies to significantly improve overactive bladder symptoms and quality of life in patients and was approved by the FDA for the treatment of overactive bladder in 2013.

Intradetrusor onabotulinumtoxinA injections are often performed in the office setting under local anesthesia. The standard technique for injecting onabotulinumtoxinA into the detrusor is mixing 100 units of onabotulinumtoxinA into 10mL of injectable normal saline and injecting 20 sites with 0.5mL in the posterior wall of hte bladder for idiopathic overactive bladder and mixing 200 units into 30mL and injecting 30 sites with 1mL for neurogenic overactive bladder. Despite instillation of local anesthetic into the bladder prior to the procedure, many patients still find the procedure uncomfortable and may elect not to have treatment or to undergo treatment under sedation.

Some literature exists that suggests that a fewer number of injections with the same dosage of onabotulinumtoxinA still provides significant improvement in symptoms for patients with the potential for fewer adverse events, specifically urinary tract infection and urinary retention requiring catheterization.

The purpose of this study is to directly compare the standard techniqe for intradetrusor onabotulinumtoxinA injections to a reduced injection technique to compare efficacy and rates of adverse events between the two groups. The hypothesis is that the reduced injection technique will be non-inferior to the standard technique.

Participants in the study will be randomized to either the standard technique or the reduced technique at the time of their procedures, provided they meet the inclusion and exclusion criteria and provide written consent to participate. Efficacy will be measured using a series of validated patient questionnaires. Scores will be obtained at a baseline and then at two other time points post-procedure (4-12 weeks and 6-9 months). Rates of adverse outcomes, specifically urinary tract infection and urinary retention requiring catheterization, will also be obtained following the procedure.

Other than the randomization of patients into study and control groups and having patients complete a series of questionnaires, the care of patients undergoing intradetrusor onabotulinumtoxinA injections will follow the standard of care. All patients will be screened for urinary tract infection prior to the procedure and if they screen positive will have their procedures delayed until after they are treated. All patients will receive pre-procedure antibiotics according to the American Urological Association guidelines. All patients will be screened for urinary retention and for symptoms of urinary tract infection at their initial post-procedure follow-up at 4-12 weeks and treated accordingly if they develop either. ;

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

• NCT number: NCT04020510
• Study type: Interventional
• Source: Walter Reed National Military Medical Center
• Contact: Angela DiCarlo-Meacham, MD
• Phone: 636-288-2955
• Email: angeladmmd@gmail.com
• Status: Recruiting
• Phase: Phase 4
• Start date: July 1, 2019
• Completion date: December 31, 2021