Standard Injections Versus Reduced Injections for Intravesical onabotulinumtoxinA Treatment of Overactive Bladder
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
Yes
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About this study
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.
Sponsor: Walter Reed National Military Medical Center
You may qualify if…
- ✓ Males or Females ≥ 18 years of age
- ✓ Predominant complaint of urinary urgency, urinary frequency or urge incontinence
- ✓ Failed at least one medication (inadequate or poorly tolerated response) or behavior modification technique (timed voiding, pelvic floor physical therapy, etc.), or decline such interventions
- ✓ Willingness to perform self-catheterization in the event of symptomatic urinary retention
- ✓ Ability to follow study instructions and likely to complete all required follow-up
You may not qualify if…
- ✕ Concurrent use of oral medications for treatment of OAB (anticholinergics or beta 3 agonists).
- ✕ Post void residual volume \> 200 ml
- ✕ Symptomatic prolapse \> POP-Q (Pelvic Organ Prolapse Quantification) stage 2 or greater that is untreated
- ✕ Evidence of active UTI (bladder infection)
- ✕ Any previous use of intradetrusor botulinum toxin (onabotulinumtoxinA or abobotulinumtoxinA) within the preceding 6 months
- ✕ Use of \>/= 400 units bontulinum toxin in the preceding 3months in other areas of the body
- ✕ Procedure performed in the main operating room (not outpatient setting)
- ✕ Concurrent diagnosis of interstitial cystitis/painful bladder syndrome
Where it's recruiting
Bethesda
Source: ClinicalTrials.gov · NCT04020510 · last updated 2020-04-28