Efficacy of Botulinum Toxin A Intradetrusor Injections for the Treatment of Non-neurogenic Urinary Urge Incontinence- A Randomized Double-Blind Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Change in Maximum Capacity at Cystoscopy Between Baseline and 6 Month Follow-up
研究概览
简要总结
Non-neurogenic urinary urge incontinence (UUI) is a common quality of life disorder that causes people to feel an "urgent" need to urinate. Standard treatment for UUI includes behavior modification, pelvic floor exercises, anticholinergic medication, and less commonly, sacral neuromodulation. Unfortunately anticholinergic therapy is only moderately effective.
Botulinum toxin A (BTA or Botox©) may be a useful treatment in patients that do not respond to standard therapy. Botulinum toxin A has been used in other studies to improve symptoms in neurogenic urinary incontinence, and a variety of lower urinary tract disorders. BTA has been used in other studies to improve the symptoms in urinary incontinence, migraines, spinal cord injuries and a variety of lower urinary tract disorders. However, the treatment of non-neurogenic urinary urge incontinence has not been examined in a well-controlled study.
The primary purpose of this study is to determine the efficacy of botulinum toxin A (BTA) in the treatment of non-neurogenic urinary urge incontinence (UUI). The secondary objectives are to examine the side effects associated with BTA treatment and the impact this treatment has on patients' quality of life.
详细描述
Introduction:
Non-neurogenic urinary urge incontinence (UUI) is a common quality of life disorder that becomes more prevalent with age. It is described as a condition that causes people to feel an "urgent" need to urinate due to muscle spasms in the bladder. Factors such as infection, inflammation, strokes, and dementia can stimulate the bladder to create spasms and cause urine loss. Overactive bladder refers to the symptom complex of urinary frequency, urgency and or nocturia with or without incontinence. Overactive bladder is a disorder of the storage phase of the bladder affecting approximately 16.9% of the US women, increasing to 31% after age 75. Standard treatment for UUI includes behavior modification, pelvic floor exercises, anticholinergic medication, and less commonly, sacral neuromodulation. Unfortunately anticholinergic therapy is only moderately effective and causes bothersome side effects, particularly at higher doses. Sacral neuromodulation therapy is currently unavailable in Saskatchewan with the closest treatment centre being located in Calgary.
Botulinum toxin A (BTA or Botox©) may be a useful treatment in patients that do not respond to standard therapy. Botulinum toxin A has been used in other studies to improve symptoms in neurogenic urinary incontinence, migraines following spinal cord injuries, and a variety of lower urinary tract disorders. This product has been approved by FDA for treatments of the following conditions: two eye muscle disorders (blepharospasm and strabismus in December 1989), severe underarm sweating (primary axillary hyperhydrosis), brow furrow and frown lines (April 2002) and other cosmetic purposes (July 2004). For the treatment of UUI, BTA is injected into the detrusor muscle of the bladder which is the muscle of the bladder that squeezes urine towards the outlet. BTA has been used in other studies to improve the symptoms in urinary incontinence and a variety of lower urinary tract disorders, however, the treatment for non-neurogenic urinary urge incontinence has not been examined in a well-controlled study.
Research Purpose and Objectives:
The primary purpose of this study is to determine the efficacy of BTA in the treatment of non-neurogenic UUI. The secondary objectives are to examine the side effects associated with BTA treatment and the impact this treatment has on patients' quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 17 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female subjects, greater than 17 years of age
- •Written informed consent has been obtained
- •Ability to follow study instructions and likely to complete all required visits
- •Written authorization for Use and Release of Health and Research Study Information has been obtained
- •Subject meets the following criteria: clinical diagnosis of urinary urge incontinence with resistance to or intolerance of anticholinergic medication
- •Anticholinergic medications allowed
- •Willingness and ability to use self-catheterization if necessary
排除标准
- •Uncontrolled clinically significant medical condition other than the condition under evaluation
- •Known allergy or sensitivity to any of the components in the study medication
- •Females with a positive pregnancy test, or who are breast-feeding, planning a pregnancy during the study, who think that they may be pregnant at the start of the study
- •Concurrent participation in another investigational drug or device study
- •Treatment with botulinum toxin of any serotype for urological condition prior to enrolment in study (if applicable)
- •Any medical condition that may put the subject at increased risk with exposure to botulinum toxin A including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other disorder that might interfere with neuromuscular function
- •Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study
- •Symptomatic urinary retention or post-void residual of >200ml
- •Anticoagulation therapy within 3 days of injection procedure
- •Familial bleeding disorder
- •UUI secondary to neurologic disease
- •Myasthenia gravis
- •Previous bladder pathology (e.g. transitional cell carcinoma)
研究组 & 干预措施
Placebos
Placebo injected into the detrusor at Day 1,
干预措施: Placebos (Drug)
Botulinum Toxins, Type A
Botulinum Toxins, Type A 100U injected into the detrusor at Day 1
干预措施: Botulinum Toxins, Type A (Drug)
结局指标
主要结局
Change in Maximum Capacity at Cystoscopy Between Baseline and 6 Month Follow-up
时间窗: Baseline to 6 months
Cystoscopy is a test performed with a cystoscope, a narrow tube with a tiny camera at its tip, inserted into the urethra and bladder to see the inside of the bladder and urethra. Maximum bladder capacity--the amount of liquid or gas the bladder can hold under anesthesia. Without anesthesia, capacity is limited by either pain or a severe urge to urinate.
次要结局
- Change in Incontinence Episodes Between Baseline and 24 Months Follow-up(Baseline and 24 months)
- Change in Number of Daytime Voids Between Baseline and 6 Week Follow-up(Baseline to 6 weeks)
- Change in Number of Night Voids Between Baseline and 6 Week Follow-up(Baseline to 6 weeks)
- Change in Number of Night Voids Between Baseline and 6 Month Follow-up(Baseline to 6 months)
- Change in Number of Night Voids Between Baseline and 9 Month Follow-up(Baseline and 9 months)
- Subjective Benefit Assessment at 6 Months(Baseline to 6 months)
- Change in Incontinence Impact Questionnaire From Baseline to 6 Weeks Follow-up(Baseline to 6 weeks)
- Frequency of Participants With Urinary Tract Infections From Baseline to 6 Months(Baseline to 6 months)
- Change in Incontinence Episodes Between Baseline and 6 Month Follow-up(Baseline to 6 month)
- Change in Incontinence Episodes Between Baseline and 12 Month Follow-up(Baseline and 12 months)
- Change in Incontinence Episodes Between Baseline and 9 Month Follow-up(Baseline to 9 months)
- Change in Number of Daytime Voids Between Baseline and 3 Month Follow-up(Baseline to 3 month)
- Change in Number of Daytime Voids Between Baseline and 12 Month Follow-up(Baseline to 12 months)
- Subjective Benefit Assessment at 3 Months(Baseline to 3 months)
- Change in Incontinence Impact Questionnaire From Baseline to 6 Months Follow-up(Baseline to 6 months)
- Change in Urogenital Distress Inventory From Baseline to 6 Months Follow-up(Baseline to 6 months)
- 24 Hour Pad Weight (gm) at 9 Months(9 months)
- Change in Incontinence Episodes Between Baseline and 6 Week Follow-up(Baseline to 6 weeks)
- Change in Incontinence Episodes Between Baseline and 3 Month Follow-up(Baseline to 3 month)
- Change in Number of Daytime Voids Between Baseline and 6 Month Follow-up(Baseline to 6 months)
- Change in Number of Night Voids Between Baseline and 12 Month Follow-up(Baseline to 12 months)
- Change in Number of Night Voids Between Baseline and 24 Months Follow-up(Baseline and 24 months)
- Change in Indevus Urgency Severity Scale From Baseline to 3 Months(Baseline to 3 months)
- 24 Hour Pad Weight (gm) at 3 Months(3 months)
- Change in Number of Daytime Voids Between Baseline and 9 Month Follow-up(Baseline to 9 months)
- Change in Number of Daytime Voids Between Baseline and 24 Month Follow-up(Baseline to 24 months)
- Change in Number of Night Voids Between Baseline and 3 Month Follow-up(Baseline to 3 months)
- Subjective Benefit Assessment at 6 Weeks(Baseline to 6 weeks)
- Change in Incontinence Impact Questionnaire From Baseline to 3 Months Follow-up(Baseline to 3 months)
- Change in Patient Perception of Bladder Condition From Baseline to 6 Weeks(Baseline to 6 weeks)
- Change in Indevus Urgency Severity Scale From Baseline to 6 Months(Baseline to 6 months)
- Change in Patient Perception of Bladder Condition From Baseline to 6 Months(Baseline to 6 months)
- Change in Indevus Urgency Severity Scale From Baseline to 6 Weeks(Baseline to 6 weeks)
- Frequency of Participants Needing Self-catheterization From Baseline to 6 Month Follow-up(Baseline to 6 months)
- Change in Urogenital Distress Inventory From Baseline to 6 Week Follow-up(Baseline to 6 weeks)
- Change in Urogenital Distress Inventory From Baseline to 3 Months Follow-up(Baseline to 3 months)
- Change in Patient Perception of Bladder Condition From Baseline to 3 Months(Baseline to 3 months)
- Frequency of Urinary Tract Infections From Baseline to 6 Months(Baseline to 6 months)
研究者
Corrine Jabs
Department Head Obstetrics & Gynecology
Saskatchewan Health Authority - Regina Area