← 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2-6 weeks

Awards & highlights

Study Summary

This trial will compare the efficacy and safety of two botulinum toxin A formulations, OnabotulinumtoxinA (BOTOX®) and IncobotulinumtoxinA (XEOMIN®), for treatment of OAB in women.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Urge urinary incontinence episodes

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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Walter Reed National Military Medical CenterLead Sponsor

137 Previous Clinical Trials

34,424 Total Patients Enrolled

Anna S Trikhacheva, MDPrincipal InvestigatorWalter Reed Army Institute of Research (WRAIR)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can Xeomin potentially cause adverse effects for those who use it?

"Our internal assessment gave Xeomin a safety rating of 2, which means that data exists to back the drug's safe usage but not its efficacy."

Answered by AI

Is it possible to join this clinical trial at the present time?

"This trial is currently recruiting participants, with the original posting appearing on 4 May 2023 and the latest amendment being made on 5 September 2023."

Answered by AI

How many people are recruited for participation in this experiment?

"Affirmative. Per the information found on clinicaltrials.gov, this medical trial is still actively recruiting participants as of September 5th 2023; it was initially posted on May 4th 20203 and requires 64 individuals across 1 site to complete the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Xeomin vs Botox for Treatment of Overactive Bladder Syndrome

2023. "Xeomin vs Botox for Treatment of Overactive Bladder Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06034288.

All > Overactive Bladder