Study of Brain Areas Involved in the Sensation of Bladder Filling in Healthy Females and Untreated Females With Overactive Bladder (OAB) Using fMRI and Water Pressure Urodynamics
试验速览
- 阶段
- 不适用
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Bladder pressure changes during the filling phase with water pressure
研究概览
简要总结
Overactive Bladder syndrome (OAB) is a medical condition with symptoms of urgency, with or without incontinence, usually with frequency and nocturia, with no proven infection or obvious pathology 1. This study will explore the relationship between OAB, obstruction and the micro contractions as well as the brain areas involved in both normal desire to void and urgency, gaining a better understanding of the bladder pathophysiology and in the future allowing better strategy of treatment options for patients suffering from OAB.
详细描述
Overactive Bladder Syndrome The International Continence Society (ICS) has defined Overactive Bladder syndrome (OAB) as a medical condition with symptoms of urgency, with or without incontinence, usually with frequency and nocturia, with no proven infection of obvious pathology.
OAB has an overall prevalence in Western Europe and the United States of 16% to 17%. Epidemiological evidence indicates that symptoms of OAB are common and likely to affect up to 50-100 million persons worldwide. In the EPIC study which was conducted in 5 countries in > 19000 men and women aged > 18 years, using the ICS definitions for OAB, the prevalence of OAB was 10.8% in men and 12.8% in women, and its prevalence increased with age. The prevalence in women for storage was 59.2%, in voiding 19.5% and in post micturition symptoms 14.2%.
The fundamental symptom is urgency, which is widely considered to be the driver of other urological symptoms. Urgency is a sudden compelling desire to pass urine, which is difficult to defer. The urological symptoms can have a considerable negative impact on quality of life, typically resulting in embarrassment and loss of dignity, which might affect relationships, intimacy and self-image.
Conventional urodynamic test Diagnostic testing of lower urinary tract function by performing urodynamic investigations is currently widely accepted. The aim of the clinical urodynamics is to produce symptoms whilst making precise measurements in order to identify underlying causes for the symptoms and to quantify the related pathophysiological processes. Urodynamics allows direct assessment of lower urinary tract function by the measurement of physiological parameters (e.g. voiding pressure parameters; minimal urethral opening detrusor pressure and urethral resistance factor), micturitions volume and leakage volume).
Urodynamics cannot be performed as an automated protocol due to current limitations of urodynamic equipment and the lack of consensus on the precise method of measurement, signal processing, quantification, documentation and interpretation. The Good Urodynamic Practices developed by ICS provides guidelines regarding the strategy for urodynamic measurement, equipment set up and configuration, signal testing, plausibility controls, pattern recognition, and artefact correction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Healthy female subjects above 18 years of age.
- •Has provided written informed consent prior to any study related procedures.
- •Overactive bladder patients
- •Inclusion Criteria:
- •Female subjects above 18 years of age.
- •Has provided written informed consent prior to any study related procedures.
- •History of signs and symptoms of OAB including urinary frequency, urgency or urge incontinence for greater than or equal to 3 months.
- •At the screening visit, the subject should be either naïve to OAB treatment (e.g. no prior history of medications to treat lower urinary tract symptoms (LUTS), including OAB) or currently on treatment for LUTS (including OAB) and is willing to undergo a washout period for 3 weeks.
- •Healthy subjects:
排除标准
- •History of lower urinary tract symptoms (LUTS), including OAB.
- •History of stress urinary incontinence, urethral sphincter incompetence and neurogenic detrusor overactivity.
- •History of signs or symptoms suggestive of urinary tract infection (confirmed by positive urine analysis).
- •History of bladder outlet obstruction (not including detrusor-overactivity) for example bladder/vesico-uterine prolapse (> grade II) or chronic obstruction.
- •History of urinary tract surgery less than or equal to 6 months prior to screening.
- •Has an indwelling catheter or permanent catheter fitted.
- •History of pelvic area radiotherapy treatment.
- •Uncontrolled diabetes mellitus.
- •History of fibromyalgia.
- •Pregnant or intends to become pregnant during the study or sexually active, of childbearing potential and is unwilling to utilize a reliable method of birth control (note: reliable methods are contraceptive pills of combination type, hormonal implants, injectable contraceptives, sexual abstinence and vasectomized partner).
- •Pregnancy within 6 months before screening or breast feeding within 3 months before screening.
- •History of positive hepatitis A, B surface antigen, hepatitis C antibody or HIV test results.
- •Any use of drugs of abuse within 3 months prior to screening visit.
- •History of smoking more than 10 cigarettes (or equivalent amount of tobacco) per day within 3 months prior to screening visit.
- •History of drinking more than 14 units of alcohol per week within 3 months prior to screening visit.
- •Has any changes to prescribed medication or to dose of prescribed medication less than or equal to 1 month prior to screening which in the opinion of the Investigator, will interfere with the study procedures or compromise safety.
- •Is currently receiving or has a history of treatment with alpha blockers, beta receptor blockers or agonists, botulinum toxin (less than 12 months), resiniferatoxin or pelvic floor muscle relaxants less than or equal to 9 months prior to screening.
- •Any clinically significant abnormality following the investigator's review of screening physical examination.
- •Any clinically significant history of any other disease or disorder- gastrointestinal, cardiovascular, respiratory, renal, hepatic, neurological, dermatological, psychiatric or metabolic as judged by the medical investigator.
- •Abnormal pulse and/or blood pressure measurements at the screening visit as follows: Pulse <40 or >90 bpm; systolic blood pressure >140 mmHg; diastolic blood pressure >90 mmHg; blood pressure and pulse measurements after subject has rested for 10 minutes.
- •Employees of the University of Maastricht involved in the study.
- •Claustrophobia, preventing a patient to have an fMRI scan
- •Patients with any metal implants in the body (except dental implants) that would prevent the patients to undergo fMRI scan.
- •For overactive bladder subjects Refer to healthy subjects exclusion criteria number 2 to number 23.
结局指标
主要结局
Bladder pressure changes during the filling phase with water pressure
时间窗: up to two hours
urodynamics during the fMRI study.
次要结局
- HADS questionnaire (self-administered) screening for anxiety and depression(cross-sectional; filling out the HADS questionnaire (15 minutes))
研究者
Sajjad Rahmana'i
M.D. PhD
Maastricht University Medical Center