Xeomin vs Botox for Treatment of Overactive Bladder Syndrome

Launched by WALTER REED NATIONAL MILITARY MEDICAL CENTER · Sep 5, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of two different treatments for Overactive Bladder Syndrome (OAB): Xeomin (incobotulinumtoxinA) and Botox (onabotulinumtoxinA). Currently, Botox is the only treatment approved by the FDA for OAB, but it is also the most expensive option. This study aims to see if Xeomin can provide similar benefits at a potentially lower cost. Women aged 18 and older who have symptoms of urinary urgency incontinence and have not found relief from previous medications or other treatments may be eligible to participate.

Participants in the trial will be randomly assigned to receive either Xeomin or Botox and will be monitored over several months. They will need to keep track of their bladder habits and complete questionnaires about their symptoms at various follow-up appointments. It's important to note that certain conditions, such as recent bladder infections or specific neurological issues, may prevent someone from participating. This study could help find a more affordable and effective option for women struggling with OAB symptoms.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Females 18 years of age or older
• • 2. Primary complaint of urinary urgency incontinence
• • 3. Failed at least one medication (inadequate or poorly tolerated response) or behavior modification technique (timed voiding, pelvic floor physical therapy, dietary modifications, etc.), or decline such interventions
• • 4. Willingness to perform self-catheterization
• • 5. Ability to follow study instructions and complete all required follow-up
• • 6. DEERS eligible
• Exclusion Criteria:
• • 1. Concurrent use of oral medications for treatment of OAB (anticholinergics or beta 3 agonists)
• • 2. Contraindication to onabotulinumtoxinA and/or incobotulinumtoxin
• • 3. Post void residual volume \> 200 ml
• • 4. Symptomatic prolapse POP-Q (Pelvic Organ Prolapse Quantification) stage three or greater that is untreated
• • 5. Evidence of active bladder infection
• • 6. Any previous use of intradetrusor botulinum toxin within the preceding 6 months
• • 7. Total body onabotulinumtoxinA and/or incobotulinumtoxinA dose of ≥ 400 Units in the 3 months prior to scheduled appointment
• • 8. Procedure performed in the main operating room (not outpatient setting)
• • 9. Concurrent diagnosis of interstitial cystitis/painful bladder syndrome
• • 10. 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
• • 11. Neurogenic bladder or other neurological disease that may cause voiding dysfunction
• • 12. Inability to speak or read English. Non-English speakers will be excluded from this study for ease of being able to allow the principal investigator to communicate with the patients during the consents, initial and all follow-up communication. Some of the questionnaires used have also only been validated in English.