BridgeMD
Compares treatment options for Urinary Bladder, Overactive
Official title Post-procedural Pain Associated With 5 Versus 20 Intravesical Injections of Onabotulinumtoxin A
ClinicalTrials.gov ID: NCT04305743
What this study is testing
What is OnabotulinumtoxinA 100 UNT?
OnabotulinumtoxinA 100 UNT is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for urinary bladder, overactive.
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
- Currently, in clinical practice there has been no standardization in the number of injections a single dose of intradetrusor onabotulinumtoxin A is administered in. Given the increasing use of this treatment modality, the aim of this study is to compare outcomes for patients given a 100 unit dose of onabotulinumtoxin A split into 5 as compared to 20 injections for the treatment of overactive bladder or urgency urinary incontinence refractory to medical treatment.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, 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, women only
You may be able to join if
- Women \>=18 years of age with diagnosis of urinary urgency, urinary frequency, urgency urinary incontinence, overactive bladder.
- Procedure scheduled in either the outpatient clinic or the operating room to be performed without use of sedation, general, or neuraxial anesthesia.
You likely can't join if
- Male gender.
- Women \<18 years of age.
- Non-English speaking.
- Pregnancy (patient will self-report pregnancy).
- Participant has symptoms of overactive bladder due to any known neurological reason (e.g. spinal cord injury, multiple sclerosis, cerebrovascular...
- Participant uses clean intermittent catheterization or indwelling catheter to manage urinary incontinence.
See the full eligibility criteria
- Women \>=18 years of age with diagnosis of urinary urgency, urinary frequency, urgency urinary incontinence, overactive bladder.
- Procedure scheduled in either the outpatient clinic or the operating room to be performed without use of sedation, general, or neuraxial anesthesia.
- Male gender.
- Women \<18 years of age.
- Non-English speaking.
- Pregnancy (patient will self-report pregnancy).
- Participant has symptoms of overactive bladder due to any known neurological reason (e.g. spinal cord injury, multiple sclerosis, cerebrovascular accident, Alzheimer's disease, Parkinson's disease, etc.)
- Participant uses clean intermittent catheterization or indwelling catheter to manage urinary incontinence.
- Participant has a history or current diagnosis of bladder cancer or other urothelial malignancy.
- Participant has a known allergy or sensitivity to any botulinum toxin preparation.
- Participant has any medical condition that may put her at increased risk with exposure to onabotulinumtoxin A, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis.
- Participant is scheduled for administration of onabotulinumtoxin A with use of sedation, general, or neuraxial anesthesia.
The study team makes the final eligibility decision.
Where it's taking place
- Washington D.C., District of Columbia, United States
- Tampa, Florida, 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 female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Washington D.C., District of Columbia, United States; Tampa, Florida, 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.