What this study is
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.
What's being tested
- onaBoNT-A
Intervention · DRUG
Intradetrusor onabotulinumtoxinA in either the standard number of injections or a reduced number of injections
Study details
- Official title
- Standard Injections Versus Reduced Injections for Intravesical onabotulinumtoxinA for Treatment of Idiopathic and Neurogenic Overactive Bladder: a Randomized Trial
- Sponsor
- Walter Reed National Military Medical Center
- Conditions
- Overactive Bladder
- Enrolling
- 184 people
- Starts
- 2019-07-01
- Est. completion
- 2021-12-31
- Design
- Open-label, randomized, parallel groups, Phase 4
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers AcceptedYou 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 can't join 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
- Females who are pregnant or planning a pregnancy during the study or who think that they may be pregnant at the start of the study, or females of childbearing potential who are unable or unwilling to use a reliable form of contraception during the study.
- Any medical condition that may put the subject at increased risk with exposure to botulinum-A toxin, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis/motor neuron disease, neuropathy, renal stones, or any other disorder that might interfere with neuromuscular function
- Known allergy or sensitivity to any of the components of onabotulinumtoxinA
- Concurrent participation in another investigational drug or device study that could impact the results
- Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openWalter Reed National Military Medical Center
Bethesda, Maryland, United States
- Angela M DiCarlo-Meacham, MD · Contact636-288-2955angeladmmd@gmail.com
- Christine Vaccaro, DO · Contact301-400-2469christine.m.vaccaro.mil@mail.mil
- Daniel Gruber, MD · Sub-investigator
- David Osborn, MD · Sub-investigator
- Katherine Dengler, MD · Sub-investigator
- Leah Scarlotta, MD · Sub-investigator
- Hector Gonzalez, MD · Sub-investigator
Recruiting
Study team
Sponsor
Walter Reed National Military Medical Center
Study ID 2019-0232
Principal investigator
Angela DiCarlo-Meacham, MD
Walter Reed National Military Medical Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.