← Back to Search

Neurotoxin

Xeomin vs Botox for Overactive Bladder

Phase 2
Recruiting
Led By Anna S Trikhacheva, MD
Research Sponsored by Walter Reed National Military Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Primary complaint of urinary urgency incontinence
Be older than 18 years old
Must not have
Contraindication to onabotulinumtoxinA and/or incobotulinumtoxin
Symptomatic prolapse POP-Q (Pelvic Organ Prolapse Quantification) stage three or greater that is untreated
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2-6 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial compares two brands of a muscle-relaxing drug for treating overactive bladder in women aged 18 and older. The treatment works by relaxing the bladder muscle to help control the urge to urinate.

Who is the study for?
This trial is for women over 18 with Overactive Bladder Syndrome who've tried at least one other treatment without success. They must be willing to self-catheterize, follow the study's instructions, and not be pregnant or planning pregnancy during the study. Participants should have no recent botox treatments for bladder issues, no severe prolapse untreated, and speak English.
What is being tested?
The trial compares two botulinum toxin A injections: Xeomin and Botox in treating Overactive Bladder Syndrome. It's a single-blinded study where participants are randomly assigned to receive either Xeomin or Botox but only the provider knows which one they get.
What are the potential side effects?
Possible side effects include pain at injection site, urinary tract infections, difficulty urinating requiring catheterization, blood in urine, fatigue, insomnia and muscle weakness near where the medicine was injected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I often feel a sudden urge to urinate and can't control it.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I cannot use certain botulinum toxin treatments due to health reasons.
Select...
I have a severe untreated pelvic organ prolapse.
Select...
I have received 400 or more units of Botox or Xeomin in the last 3 months.
Select...
My surgery will be in the main hospital operating room.
Select...
I have been diagnosed with painful bladder syndrome.
Select...
I am not pregnant, planning to become pregnant, or unwilling to use contraception during the study.
Select...
I have a bladder condition or nerve disease affecting my ability to urinate.
Select...
I can speak and read English.
Select...
I am currently taking oral medication for overactive bladder.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2-6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2-6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Urge urinary incontinence episodes

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: XeominExperimental Treatment1 Intervention
100units xeomin dilated in 10mL injectable saline will be injected into the detrusor muscle to a depth of 3mm at 20 sites at 0.5mL volume each
Group II: BotoxActive Control1 Intervention
100units Botox dilated in 10mL injectable saline will be injected into the detrusor muscle to a depth of 3mm at 20 sites at 0.5mL volume each

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Overactive Bladder (OAB) include antimuscarinic agents, beta3-adrenoceptor agonists, and botulinum toxin injections. Antimuscarinic agents, such as tolterodine and solifenacin, work by blocking muscarinic receptors in the bladder, reducing involuntary muscle contractions. Beta3-adrenoceptor agonists, like mirabegron, relax the bladder muscle by stimulating beta3 receptors. Botulinum toxin injections, such as IncobotulinumtoxinA (Xeomin®), block the release of acetylcholine at the neuromuscular junction, leading to reduced muscle contractions in the bladder. These mechanisms are crucial for OAB patients as they help manage symptoms like urinary urgency, frequency, and incontinence, thereby improving quality of life.

Find a Location

Who is running the clinical trial?

Walter Reed National Military Medical CenterLead Sponsor
140 Previous Clinical Trials
33,109 Total Patients Enrolled
Anna S Trikhacheva, MDPrincipal InvestigatorWalter Reed Army Institute of Research (WRAIR)
~25 spots leftby Dec 2025