Status:
RECRUITING
Standard Injections Versus Reduced Injections for Intravesical onabotulinumtoxinA Treatment of Overactive Bladder
Lead Sponsor:
Walter Reed National Military Medical Center
Conditions:
Overactive Bladder
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 onabotulinumto...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
184 Patients enrolled
Trial Details
Trial ID
NCT04020510
Start Date
July 1 2019
End Date
December 31 2021
Last Update
April 28 2020
Active Locations (1)
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1
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889