Actively Recruiting

Phase 4
Age: 18Years +
FEMALE
ID04305743

Post-procedural Pain Associated With 5 Versus 20 Intravesical Injections of Onabotulinumtoxin A for Treatment of Overactive Bladder: a Multi-center Randomized Controlled Trial

Led by University of South Florida · Updated on 2020-11-05

60

Participants Needed

2

Research Sites

21 weeks

Total Duration

On this page

Sponsors

U

University of South Florida

Lead Sponsor

M

Medstar Health Research Institute

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying the effects of different injection methods of onabotulinumtoxin A for women with overactive bladder or urgency urinary incontinence that has not improved with medication. This study compares outcomes between giving a 100 unit dose split into 5 injections versus 20 injections. The purpose is to see if the number of injections affects post-procedural pain and other treatment results. Participants receive a single procedure where their bladder is prepared with lidocaine. Then, onabotulinumtoxin A is injected into the bladder muscle either as 5 injections of 2 mL each or 20 injections of 0.5 mL each, totaling 100 units diluted in 10 mL. Both groups undergo cystoscopy with the same needle type and injection spacing. During the study, researchers will measure pain within 5 minutes after the procedure. They will also track procedure duration, treatment response at 6 weeks, and any urinary tract infections or retention up to 12 weeks afterward. Participants are monitored closely, with all visits and assessments designed to evaluate safety and treatment outcomes over this period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women 18 years of age or older with diagnosis of urinary urgency, urinary frequency, urgency urinary incontinence, or overactive bladder.
  • Procedure scheduled in outpatient clinic or operating room to be performed without sedation, general, or neuraxial anesthesia.
Not Eligible

You will not qualify if you...

  • Male gender.
  • Women under 18 years of age.
  • Non-English speaking.
  • Pregnancy (self-reported).
  • Overactive bladder symptoms due to known neurological conditions (e.g., spinal cord injury, multiple sclerosis, cerebrovascular accident, Alzheimer's disease, Parkinson's disease).
  • Use of clean intermittent catheterization or indwelling catheter for urinary incontinence.
  • History or current diagnosis of bladder cancer or other urothelial malignancy.
  • Known allergy or sensitivity to any botulinum toxin preparation.
  • Medical conditions increasing risk with onabotulinumtoxin A exposure, including myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis.
  • Scheduled for onabotulinumtoxin A administration with sedation, general, or neuraxial anesthesia.

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single procedure day

Participants receive a single intradetrusor injection of onabotulinumtoxin A as either 5 or 20 injections in one procedure to treat overactive bladder.

1 procedure visit (in-person)

Follow-up

Duration - Up to 12 weeks post-procedure

Participants are monitored for treatment response, urinary tract infections, and urinary retention after the procedure.

Visits at approximately 6 and 12 weeks post-procedure

Trial Site Locations

Total: 2 locations

1

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States, 20010

Actively Recruiting

2

University of South Florida Health South Tampa Center for Advanced Healthcare

Tampa, Florida, United States, 33606

Actively Recruiting

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Research Team

E

Eric S Chang, MD

A

Allison Wyman, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Postprocedural Pain Associated With 5 Versus 20 Intradetrusor Injections of onabotulinumtoxinA for Treatment of Overactive Bladder: A Multicenter Randomized Clinical Trial.

Eric S Chang, Nancy Ringel, Katherine L Woodburn...

https://pubmed.ncbi.nlm.nih.gov/35543540