Status:
UNKNOWN
Xeomin vs Botox for Treatment of Overactive Bladder Syndrome
Lead Sponsor:
Walter Reed National Military Medical Center
Conditions:
Overactive Bladder Syndrome
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
Purpose: Multiple formulations and brands of botulinum toxin exist on the market today. Only OnabotulinumtoxinA (BOTOX®) is currently FDA approved for treatment of overactive bladder. Incobotulinumtox...
Detailed Description
The study will be registered on clinicaltrials.gov after IRB approval. Institutional Review Board (IRB) approval will be received. All women 18 years of age and older with bothersome overactive bladd...
Eligibility Criteria
Inclusion
- Females 18 years of age or older
- Primary complaint of urinary urgency incontinence
- 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
- Willingness to perform self-catheterization
- Ability to follow study instructions and complete all required follow-up
- DEERS eligible
Exclusion
- Concurrent use of oral medications for treatment of OAB (anticholinergics or beta 3 agonists)
- Contraindication to onabotulinumtoxinA and/or incobotulinumtoxin
- Post void residual volume \> 200 ml
- Symptomatic prolapse POP-Q (Pelvic Organ Prolapse Quantification) stage three or greater that is untreated
- Evidence of active bladder infection
- Any previous use of intradetrusor botulinum toxin within the preceding 6 months
- Total body onabotulinumtoxinA and/or incobotulinumtoxinA dose of ≥ 400 Units in the 3 months prior to scheduled appointment
- 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
- Neurogenic bladder or other neurological disease that may cause voiding dysfunction
- 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.
Key Trial Info
Start Date :
May 4 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2024
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT06034288
Start Date
May 4 2023
End Date
September 30 2024
Last Update
October 13 2023
Active Locations (1)
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1
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889