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

Description

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.

Conditions

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Urinary Bladder, Overactive
Intervention / Treatment

-

Contacts and Locations

Washington

MedStar Washington Hospital Center, Washington, District of Columbia, United States, 20010

Tampa

University of South Florida Health South Tampa Center for Advanced Healthcare, Tampa, Florida, United States, 33606

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of South Florida,

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

Study Record Dates

2021-06-01