Comparing Xeomin and Botox for Overactive Bladder Treatment
IncobotulinumtoxinA (Xeomin®) vs OnabotulimuntoxinA (Botox®) for Treatment of Overactive Bladder Syndrome: Randomized Non-Inferiority Trial
This study is testing whether Xeomin works as well as Botox for treating overactive bladder in women to see if it could be a cheaper option.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Walter Reed National Military Medical Center Federal |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT06034288 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the efficacy of two formulations of botulinum toxin, Xeomin and Botox, in treating overactive bladder syndrome in women. It is a single-blinded, randomized non-inferiority trial conducted at Walter Reed National Military Medical Center. Eligible participants will undergo a thorough assessment and will be randomly assigned to receive either Xeomin or Botox injections. The study seeks to determine if Xeomin can provide similar benefits to Botox while potentially being a more cost-effective option.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 and older who experience urinary urgency incontinence and have either failed previous treatments or declined them.
Not a fit: Patients who are currently using oral medications for overactive bladder or have contraindications to botulinum toxin treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more affordable treatment option for women suffering from overactive bladder syndrome.
How similar studies have performed: While Botox is currently the only FDA-approved treatment for overactive bladder, this study is exploring the use of Xeomin, which has not been extensively tested for this specific condition.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bethesda, Maryland
- Walter Reed National Military Medical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Anna S Trikhacheva, MD — Walter Reed Army Institute of Research (WRAIR)
- Study coordinator: Anna S Trikhacheva, MD
- Email: ann_trik@hotmail.com
- Phone: 7162353843
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.