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Study on OnabotulinumtoxinA Injections for Overactive Bladder

This study is looking at how the number of injections of OnabotulinumtoxinA (a medication used to treat overactive bladder) affects pain during the procedure. Currently, there's no standard for how many injections are given. This research compares giving 100 units of OnabotulinumtoxinA as 5 injections versus 20 injections. You may be able to join if you are a woman aged 18 or older with urinary urgency, frequency, or incontinence, and your procedure is scheduled without sedation. The main goal is to see if one method causes less pain right after the procedure. The study plans to enroll 60 participants, but its current status is unclear.

Study design
This interventional study will enroll 60 women. Participants will be randomly assigned to receive either 5 or 20 injections of OnabotulinumtoxinA.
What's involved
You would undergo a cystoscopic procedure where OnabotulinumtoxinA is injected into your bladder. Your pain level will be measured within 5 minutes of the procedure finishing.
Compensation
Not stated in the trial record.
Follow-up
Pain from the procedure is measured within 5 minutes of completion. No further follow-up is specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04305743

Post-procedural Pain Associated With 5 Versus 20 Intravesical Injections of Onabotulinumtoxin A

Recruiting
PHASE4Ages 18+InterventionalTreatment
University of South Florida
~60 participants
Updated 2020-11-05 on ClinicalTrials.gov
What's tested:OnabotulinumtoxinA 100 UNT

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pain from procedure: score
Measured over Within 5 minutes of procedure completion

Conditions

Urinary Bladder, Overactive
Incontinence, Urge
Incontinence, Urinary
Urinary Urge Incontinence
Urinary Frequency More Than Once at Night
Nocturia

Explore related trials

Overactive BladderUrge incontinence of urine

Where it's being run

2 sites across 2 states
District of Columbia1
Florida1

Study leadership

  • Eric S Chang, MD · PRINCIPAL_INVESTIGATOR · University of South Florida

Who to contact

Eric S Chang, MD
[email protected]
813-259-8500
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

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.

What this trial measures

  • Pain from procedure: scoreWithin 5 minutes of procedure completion

    Pain score as rated on a 10-point visual analog scale within 5 minutes of procedure completion