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Compares treatment options for Overactive Bladder
Official title Standard Injections Versus Reduced Injections for Intravesical onabotulinumtoxinA Treatment of Overactive Bladder
ClinicalTrials.gov ID: NCT04020510
What this study is testing
What is onaBoNT-A?
onaBoNT-A is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for overactive bladder.
Also referred to as Botox.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join 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...
- 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 likely 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
See the full eligibility criteria
- 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
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.