Comparing standard and reduced injections of onabotulinumtoxinA for overactive bladder treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to compare the efficacy of a reduced number of injections of onabotulinumtoxinA against the standard injection technique for treating overactive bladder. The standard method involves multiple injections with a specific dosage, while the reduced technique seeks to maintain efficacy with fewer injections. The study hypothesizes that the reduced technique will not only be equally effective but may also lead to fewer complications, such as urinary tract infections and urinary retention. Participants will be monitored for symptom improvement and any adverse events following the procedure.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Males or Females ≥ 18 years of age
* Predominant complaint of urinary urgency, urinary frequency or urge incontinence
* 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
* Willingness to perform self-catheterization in the event of symptomatic urinary retention
* Ability to follow study instructions and likely to complete all required follow-up

Exclusion Criteria:

* Concurrent use of oral medications for treatment of OAB (anticholinergics or beta 3 agonists).
* Post void residual volume \> 200 ml
* Symptomatic prolapse \> POP-Q (Pelvic Organ Prolapse Quantification) stage 2 or greater that is untreated
* Evidence of active UTI (bladder infection)
* Any previous use of intradetrusor botulinum toxin (onabotulinumtoxinA or abobotulinumtoxinA) within the preceding 6 months
* Use of \>/= 400 units bontulinum toxin in the preceding 3months in other areas of the body
* Procedure performed in the main operating room (not outpatient setting)
* Concurrent diagnosis of interstitial cystitis/painful bladder syndrome
* 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.
* 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
* Known allergy or sensitivity to any of the components of onabotulinumtoxinA
* Concurrent participation in another investigational drug or device study that could impact the results
* 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

Where it's running

• Walter Reed National Military Medical Center
  Bethesda, Maryland, United States Recruiting

Study contacts

• Principal investigator: Angela DiCarlo-Meacham, MD — Walter Reed National Military Medical Center
• Study coordinator: Angela DiCarlo-Meacham, MD
• Email: angeladmmd@gmail.com
• Phone: 636-288-2955

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.