RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2019-10-09
Study Completion:2021-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04305743

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Women \>=18 years of age with diagnosis of urinary urgency, urinary frequency, urgency urinary incontinence, overactive bladder.
  2. * Procedure scheduled in either the outpatient clinic or the operating room to be performed without use of sedation, general, or neuraxial anesthesia.
  1. * Male gender.
  2. * Women \<18 years of age.
  3. * Non-English speaking.
  4. * Pregnancy (patient will self-report pregnancy).
  5. * 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.)
  6. * Participant uses clean intermittent catheterization or indwelling catheter to manage urinary incontinence.
  7. * Participant has a history or current diagnosis of bladder cancer or other urothelial malignancy.
  8. * Participant has a known allergy or sensitivity to any botulinum toxin preparation.
  9. * 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.
  10. * Participant is scheduled for administration of onabotulinumtoxin A with use of sedation, general, or neuraxial anesthesia.

Contacts and Locations

Study Contact

Eric S Chang, MD
CONTACT
813-259-8500
ericchang@usf.edu
Allison Wyman, MD
CONTACT
813-259-8500
awyman@usf.edu

Principal Investigator

Eric S Chang, MD
PRINCIPAL_INVESTIGATOR
University of South Florida

Study Locations (Sites)

MedStar Washington Hospital Center
Washington, District of Columbia, 20010
United States
University of South Florida Health South Tampa Center for Advanced Healthcare
Tampa, Florida, 33606
United States

Collaborators and Investigators

Sponsor: University of South Florida

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-10-09
Study Completion Date2021-06-01

Study Record Updates

Study Start Date2019-10-09
Study Completion Date2021-06-01

Terms related to this study

Keywords Provided by Researchers

  • overactive bladder
  • urgency urinary incontinence
  • onabotulinumtoxin
  • bladder
  • botox

Additional Relevant MeSH Terms

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