Xeomin vs Botox for Treatment of Overactive Bladder Syndrome

NCT06034288 | Unknown Phase 2 FDA Drug

• 1 other identifier: WRNMMC-2022-0398
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: Multiple formulations and brands of botulinum toxin exist on the market today. Only OnabotulinumtoxinA (BOTOX®) is currently FDA approved for treatment of overactive bladder. IncobotulinumtoxinA (XEOMIN®) is a similar formulation of botulinum toxin A that has similar dosing and safety profile at onabotulinumtoxinA. OnabotulinumtoxinA is the most expensive formulation on the market. Compare the efficacy of incobotulinumtoxinA (Xeomin®, Merz Pharmaceuticals) to onabotulinumtoxinA (Botox®, Allergan) for treatment of OAB. Study design: A single-blinded, randomized non-inferiority trial of IncobotulinumtoxinA (Xeomin®, Merz Pharmaceuticals) to OnabotulinumtoxinA (Botox®, Allergan) in treatment of OAB. Target Population: The study findings will be applicable to all women 18 years of age or older with OAB symptoms associated with urinary urgency incontinence. Procedure: All patients that presents to urogynecology clinic at Walter Reed National Medical Military Center will be screened for inclusion and exclusion criteria. Patients that meet criteria will be offered to participate in the study. After enrollment patient will complete demographics data sheet, 24 hours bladder diary, OAB-q SF, PGI-S, PISQ-IR. Patients will be randomized by the principal investigator and the allocated treatment will be reveled by the treating provider to the treating provider only. Patient will have a follow up at 2-6 weeks and 6-9 months after procedure. During the follow up appointments patient will be asked to fill out 24-hour voiding diary, OAB-q SF, PGI-I, PGI-S, and PISQ-IR surveys.

Conditions

Overactive Bladder Syndrome

Outcome Measures

Primary Outcomes (1)

• Urge urinary incontinence episodes

  To evaluate non-inferiority of incobotulinumtoxinA to onabotulinumtoxinA for treatment of OAB by using number of incontinence episodes on a 24-hours bladder diary at 2-6 weeks post injection

  2-6 weeks

Study Arms (2)

Xeomin

EXPERIMENTAL

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

Drug: Xeomin 100 UNT Injection

Botox

ACTIVE COMPARATOR

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

Drug: Botox 100 UNT Injection

Interventions

Xeomin 100 UNT Injection DRUG

intravesical injection

Also known as: incobotulinumtoxinA

Xeomin

Botox 100 UNT Injection DRUG

intravesical injection

Also known as: onabotulinumtoxinA

Botox

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females 18 years of age or older
• Primary complaint of urinary urgency incontinence
• 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
• Willingness to perform self-catheterization
• Ability to follow study instructions and complete all required follow-up
• DEERS eligible

You may not qualify if:

• Concurrent use of oral medications for treatment of OAB (anticholinergics or beta 3 agonists)
• Contraindication to onabotulinumtoxinA and/or incobotulinumtoxin
• Post void residual volume \> 200 ml
• Symptomatic prolapse POP-Q (Pelvic Organ Prolapse Quantification) stage three or greater that is untreated
• Evidence of active bladder infection
• Any previous use of intradetrusor botulinum toxin within the preceding 6 months
• Total body onabotulinumtoxinA and/or incobotulinumtoxinA dose of ≥ 400 Units in the 3 months prior to scheduled appointment
• Procedure performed in the main operating room (not outpatient setting)
• Concurrent diagnosis of interstitial cystitis/painful bladder syndrome
• 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
• Neurogenic bladder or other neurological disease that may cause voiding dysfunction
• 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.

Sponsors & Collaborators

• Walter Reed National Military Medical Center: lead

Study Sites (1)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

RECRUITING

MeSH Terms

Interventions

incobotulinumtoxinA; Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Anna S Trikhacheva, MD

  Walter Reed Army Institute of Research (WRAIR)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna S Trikhacheva, MD

CONTACT

7162353843; ann_trik@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: September 13, 2023
• Study Start: May 4, 2023
• Primary Completion: June 30, 2024
• Study Completion: September 30, 2024
• Last Updated: October 13, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)