NL-OMON55567招募中不适用
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 - Brain areas involved in bladder filling and contraction.
Medisch Universitair Ziekenhuis Maastricht0 个研究点目标入组 48 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Healthy Subjects
- •1. Healthy female subjects aged 18 or older
- •2. Has provided written informed consent prior to any study related
- •procedures., OAB Subjects
- •1. Female subjects aged 18 or older
- •2. Has provided written informed consent prior to any study related procedures.
- •3. History of signs and symptoms of OAB including urinary frequency, urgency or
- •urge incontinence for greater than or equal to 3 months.
- •4. At enrolment visit (V2) the subjects must have:
- •- At least 1 episode of urgency with or without incontinence in the last 3-day
- •micturition diary.
- •- Frequency of micturition greater than or equal to 8 per 24 hours period
- •during the 3-day micturition diary period
- •5. 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.
排除标准
- •Exclusion Criteria, 1. History of lower urinary tract symptoms (LUTS),
- •including OAB (healthy subjects)
- •2. History of stress urinary incontinence, urethral sphincter incompetence and
- •neurogenic detrusor overactivity .
- •3. History of signs or symptoms suggestive of urinary tract infection
- •(confirmed by positive urine analysis).
- •4. History of bladder outlet obstruction (not including detrusor-overactivity)
- •for example bladder/vesicouterine pro-lapse (> grade II) or chronic obstruction.
- •5. History of urinary tract surgery less than or equal to 6 months prior to
- •6. Has an indwelling catheter or permanent catheter fitted.
- •7. History of pelvic area radiotherapy treatment.
- •8. Uncontrolled diabetes mellitus.
- •9. History of fibromyalgia.
- •10. 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).
- •11. Pregnancy within 6 months before screening or breast feeding within 3
- •months before screening.
- •12. History of positive hepatitis A, B surface antigen, hepatitis C antibody or
- •HIV test result.
- •13. Any use of drugs of abuse within 3 months prior to screening visit.
- •14. History of smoking more than 10 cigarettes (or equivalent amount of
- •tobacco) per day within 3 months prior to screening visit.
- •15. History of drinking more than 14 units of alcohol per week (1 unit = 10 g
- •pure alcohol = 250 ml of beer (5%) or 35 ml of spirits (35%) or 100 ml of wine
- •(12%) within 3 months prior to screening visit.
- •16. 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.
- •17. 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.
- •18. Any clinically significant abnormality following the investigator*s review
- •of screening physical examination.
- •19. 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.
- •20. 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.
- •21. Participation in any clinical study within 3 months or participation in
- •more than 3 clinical studies within 12 months, prior to the expected date of
- •enrolment into the study, provided that the clinical study did not entail a
- •biological compound with a long terminal half life.
- •22. Any clinical condition, which, in the opinion of the investigator would not
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研究者
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