What side effects are associated with this type of intervention?

Common treatments for Overactive Bladder (OAB) include botulinum toxin injections like IncobotulinumtoxinA (Xeomin®) and anticholinergic medications. Botulinum toxin injections can lead to side effects such as urinary tract infections, urinary retention, and the need for intermittent catheterization. Anticholinergic medications may cause dry mouth, constipation, blurred vision, and cognitive dysfunction, particularly in older adults. Both treatments aim to reduce bladder muscle contractions but have distinct potential adverse effects.

What prior FDA approvals exist?

The FDA has approved OnabotulinumtoxinA (Botox®) for the treatment of Overactive Bladder (OAB). This drug, like IncobotulinumtoxinA (Xeomin®), works by blocking the release of acetylcholine at the neuromuscular junction, thereby reducing muscle contractions in the bladder. Other pharmacological treatments for OAB include anticholinergic medications such as tolterodine and solifenacin, which also reduce bladder muscle contractions but through a different mechanism by blocking muscarinic receptors. Additionally, beta-3 adrenergic agonists like mirabegron have been approved, which relax the bladder muscle by stimulating beta-3 adrenergic receptors.

What other types of research exist?

Promising novel alternatives to IncobotulinumtoxinA (Xeomin®) for Overactive Bladder patients include: 1) Mirabegron, a beta-3 adrenergic agonist that relaxes the bladder muscle to increase storage capacity. 2) Vibegron, another beta-3 adrenergic agonist with a similar mechanism to Mirabegron but potentially fewer side effects. 3) Percutaneous Tibial Nerve Stimulation (PTNS), a minimally invasive neuromodulation technique that reduces OAB symptoms by modulating nerve activity. 4) Sacral Neuromodulation, an implantable device that stimulates the sacral nerves to improve bladder control. These alternatives offer different mechanisms of action and may provide effective symptom relief for OAB patients.

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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.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2-6 weeks

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

0 / 10Eligibility criteria met

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.