IncobotulinumtoxinA (Xeomin®) vs OnabotulimuntoxinA (Botox®) for Treatment of Overactive Bladder Syndrome: Randomized Non-Inferiority Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Urge urinary incontinence episodes
研究概览
简要总结
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.
详细描述
The study will be registered on clinicaltrials.gov after IRB approval. Institutional Review Board (IRB) approval will be received.
All women 18 years of age and older with bothersome overactive bladder symptoms who are receiving care at Walter Reed National Military Medical Center (WRNMMC) in the urogynecology clinic will be eligible for the study.
All study participants will undergo a complete intake assessment to include a history, physical exam, post-void bladder residual volume assessment via straight catheterization or ultrasound, and counseling on treatment modalities for OAB using the AUGS handout to include behavioral and dietary modifications, physical therapy, oral medications, onabotulinumtoxinA and neuromodulation. Patients desiring treatment with onabotulinumtoxinA will be scheduled for the procedure. Patients do not have to fail prior treatment options in order to qualify for bladder BOTOX. This is all standard of care in our practice. All patients meeting the inclusion and exclusion criteria will be offered enrollment in this study. Enrollment will be done by the research team, who typically are also the clinicians. No patients will be pressured or coerced into participating in the study.
Prior to the procedure appointment, participants will be consented for participation in the study and asked to complete demographics data sheet, 24 hours bladder diary, OAB-q SF, PGI-S, PISQ-IR. OAB-q SF is a standard of are in our practice, all other questionnaires patient will fill out for the purpose of this study.
The procedure will be performed at Walter Reed National Military Medical Center either in clinic setting or in the operating room. All patients who plan to undergo the procedure in clinic will be offered a pre-treatment anxiolytic with a single dose of 5-10mg of oral diazepam, which is standard practice at this institution. Patients undergoing the procedure in the operating room, will be given sedation medications as per standard of care. As standard of treatment, patients will also be given a prescription for an antibiotic - either nitrofurantoin 100mg to take orally twice daily for 3 days starting the day of the procedure, or trimethoprim-sulfamethoxazole 800mg-160mg to take orally twice daily for 3 days starting the day of the procedure depending on patient's allergy profile.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Botox
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
干预措施: Botox 100 UNT Injection (Drug)
Xeomin
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
干预措施: Xeomin 100 UNT Injection (Drug)
结局指标
主要结局
Urge urinary incontinence episodes
时间窗: 2-6 weeks
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
次要结局
未报告次要终点