RECRUITING

Xeomin vs Botox for Treatment of Overactive Bladder Syndrome

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

IncobotulinumtoxinA (Xeomin®) vs OnabotulimuntoxinA (Botox®) for Treatment of Overactive Bladder Syndrome: Randomized Non-Inferiority Trial

Quick Facts

Study Start:2023-05-04

Study Completion:2024-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06034288

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Females 18 years of age or older 2. Primary complaint of urinary urgency incontinence 3. 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 4. Willingness to perform self-catheterization 5. Ability to follow study instructions and complete all required follow-up 6. DEERS eligible	1. Concurrent use of oral medications for treatment of OAB (anticholinergics or beta 3 agonists) 2. Contraindication to onabotulinumtoxinA and/or incobotulinumtoxin 3. Post void residual volume \> 200 ml 4. Symptomatic prolapse POP-Q (Pelvic Organ Prolapse Quantification) stage three or greater that is untreated 5. Evidence of active bladder infection 6. Any previous use of intradetrusor botulinum toxin within the preceding 6 months 7. Total body onabotulinumtoxinA and/or incobotulinumtoxinA dose of ≥ 400 Units in the 3 months prior to scheduled appointment 8. Procedure performed in the main operating room (not outpatient setting) 9. Concurrent diagnosis of interstitial cystitis/painful bladder syndrome 10. 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 11. Neurogenic bladder or other neurological disease that may cause voiding dysfunction 12. 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.

Inclusion Criteria

Exclusion Criteria

1. Females 18 years of age or older
2. Primary complaint of urinary urgency incontinence
3. 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
4. Willingness to perform self-catheterization
5. Ability to follow study instructions and complete all required follow-up
6. DEERS eligible

1. Concurrent use of oral medications for treatment of OAB (anticholinergics or beta 3 agonists)
2. Contraindication to onabotulinumtoxinA and/or incobotulinumtoxin
3. Post void residual volume \> 200 ml
4. Symptomatic prolapse POP-Q (Pelvic Organ Prolapse Quantification) stage three or greater that is untreated
5. Evidence of active bladder infection
6. Any previous use of intradetrusor botulinum toxin within the preceding 6 months
7. Total body onabotulinumtoxinA and/or incobotulinumtoxinA dose of ≥ 400 Units in the 3 months prior to scheduled appointment
8. Procedure performed in the main operating room (not outpatient setting)
9. Concurrent diagnosis of interstitial cystitis/painful bladder syndrome
10. 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
11. Neurogenic bladder or other neurological disease that may cause voiding dysfunction
12. 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.

Contacts and Locations

Study Contact

Anna S Trikhacheva, MD

CONTACT

7162353843

ann_trik@hotmail.com

Principal Investigator

Anna S Trikhacheva, MD

PRINCIPAL_INVESTIGATOR

Walter Reed Army Institute of Research (WRAIR)

Study Locations (Sites)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889

United States

Collaborators and Investigators

Sponsor: Walter Reed National Military Medical Center

Anna S Trikhacheva, MD, PRINCIPAL_INVESTIGATOR, Walter Reed Army Institute of Research (WRAIR)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-04

Study Completion Date2024-09-30

Study Record Updates

Study Start Date2023-05-04

Study Completion Date2024-09-30

Terms related to this study

Additional Relevant MeSH Terms

Overactive Bladder Syndrome