Xeomin vs Botox for Overactive Bladder

Recruiting in Palo Alto (17 mi)

Overseen by Anna S Trikhacheva, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Walter Reed National Military Medical Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Anna S Trikhacheva, MD

Principal Investigator

Walter Reed Army Institute of Research (WRAIR)

Eligibility Criteria

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.

Inclusion Criteria

I can follow the study's instructions and attend all follow-ups.

I have tried at least one treatment or behavior change for my condition without success, or I chose not to try them.

I am a woman aged 18 or older.

Exclusion Criteria

I have not had botulinum toxin injections in my bladder in the last 6 months.

I cannot use certain botulinum toxin treatments due to health reasons.

I have a severe untreated pelvic organ prolapse.

Treatment Details

Interventions

• Botox (Neurotoxin)
• Xeomin (Neurotoxin)

Trial Overview 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.

Participant Groups

Group I: Xeomin Experimental Treatment 1 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: Botox Active Control 1 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

Who Is Running the Clinical Trial?

Walter Reed National Military Medical Center

Lead Sponsor

Trials

149

Recruited

33,800+

Melissa C. Austin

Walter Reed National Military Medical Center

Chief Executive Officer since 2020

MD from University of Colorado Health Sciences Center

Melissa C. Austin

Walter Reed National Military Medical Center

Chief Medical Officer since 2020

MD, Board Certified in Anatomic and Clinical Pathology