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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorWalter Reed National Military Medical Center

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • onaBoNT-A

Treatment groups

184 Participants
are divided into 2 treatment groups