RECRUITING

Standard Injections Versus Reduced Injections for Intravesical onabotulinumtoxinA Treatment of Overactive Bladder

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Conditions

Overactive Bladder

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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

OnabotulinumtoxinA is an effective treatment for both idiopathic and neurogenic overactive bladder and was FDA approved for this indication in 2013. The standard technique for injecting onabotulinumtoxinA into the detrusor is mixing 100 units of onabotulinumtoxinA into 10mL of injectable normal saline and injecting 20 sites with 0.5mL in the posterior wall of hte bladder for idiopathic overactive bladder and mixing 200 units into 30mL and injecting 30 sites with 1mL for neurogenic overactive bladder. The purpose of this study is to compare the efficacy of a technique using a reduced number of injections with the same dosage of onabotulinumtoxinA to the standard technique. The hypothesis is that the reduced technique will not be inferior in terms of efficacy as the standard technique and that there will be a lower incidence of urinary tract infections and urinary retention requiring catheterization post-procedure.

Official Title

Standard Injections Versus Reduced Injections for Intravesical onabotulinumtoxinA for Treatment of Idiopathic and Neurogenic Overactive Bladder: a Randomized Trial

Quick Facts

Study Start:2019-07-01
Study Completion:2021-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04020510

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:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Males or Females ≥ 18 years of age
  2. * Predominant complaint of urinary urgency, urinary frequency or urge incontinence
  3. * Failed at least one medication (inadequate or poorly tolerated response) or behavior modification technique (timed voiding, pelvic floor physical therapy, etc.), or decline such interventions
  4. * Willingness to perform self-catheterization in the event of symptomatic urinary retention
  5. * Ability to follow study instructions and likely to complete all required follow-up
  1. * Concurrent use of oral medications for treatment of OAB (anticholinergics or beta 3 agonists).
  2. * Post void residual volume \> 200 ml
  3. * Symptomatic prolapse \> POP-Q (Pelvic Organ Prolapse Quantification) stage 2 or greater that is untreated
  4. * Evidence of active UTI (bladder infection)
  5. * Any previous use of intradetrusor botulinum toxin (onabotulinumtoxinA or abobotulinumtoxinA) within the preceding 6 months
  6. * Use of \>/= 400 units bontulinum toxin in the preceding 3months in other areas of the body
  7. * Procedure performed in the main operating room (not outpatient setting)
  8. * Concurrent diagnosis of interstitial cystitis/painful bladder syndrome
  9. * Females who are pregnant or planning a pregnancy during the study or who think that they may be pregnant at the start of the study, or females of childbearing potential who are unable or unwilling to use a reliable form of contraception during the study.
  10. * Any medical condition that may put the subject at increased risk with exposure to botulinum-A toxin, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis/motor neuron disease, neuropathy, renal stones, or any other disorder that might interfere with neuromuscular function
  11. * Known allergy or sensitivity to any of the components of onabotulinumtoxinA
  12. * Concurrent participation in another investigational drug or device study that could impact the results
  13. * Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study

Contacts and Locations

Study Contact

Angela DiCarlo-Meacham, MD
CONTACT
636-288-2955
angeladmmd@gmail.com

Principal Investigator

Angela DiCarlo-Meacham, MD
PRINCIPAL_INVESTIGATOR
Walter Reed National Military Medical Center

Study Locations (Sites)

Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
United States

Collaborators and Investigators

Sponsor: Walter Reed National Military Medical Center

  • Angela DiCarlo-Meacham, MD, PRINCIPAL_INVESTIGATOR, Walter Reed National Military Medical Center

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 Date2019-07-01
Study Completion Date2021-12-31

Study Record Updates

Study Start Date2019-07-01
Study Completion Date2021-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Overactive Bladder