EUCTR2005-004995-20-GB进行中（未招募）1 期
A Prospective, Single-Arm, Open-label Study to Investigate the Efficacy and Safety of Intravesical Injection of Botulinum Toxin Type-A (500 Units Dysport®) for the Management of Idiopathic Overactive Bladder Syndrome. - Botulinum Toxin for the Management of Neurogenic Detrusor Overactivity
R and D Department, Cardiff and the Vale NHS Trust0 个研究点目标入组 50 人开始时间: 2006年1月13日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. The patient must give informed consent before completing any study-related procedure, which means any assessment or evaluation that would not have formed part of their normal medical care.
- •2. The patient must be between 18 and 75 years of age inclusive.
- •3. The patient must have a clinical diagnosis of Overactive Bladder Syndrome without any neurogenic cause, with or without evidence of detrusor overactivity on conventional urodynamic assessment.
- •4. The patient must have Overactive Bladder Syndrome resistant to anticholinergic medication, or suffer unacceptable side effects from anticholinergic therapy.
- •5. The patient must be fit for flexible cystoscopy under local anaesthetic.
- •6. The patient must be willing and able to use clean intermittent self-catheterisation (CISC) if this becomes necessary.
- •7. The patient must be competent to give informed consent.
- •8. The patient must be able and willing to comply with the requirements of the protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. The patient has significant coexisting genuine stress incontinence.
- •2. The patient is suffering from any severe concomitant medical illness, or has significantly reduced renal or hepatic function.
- •3. The patient has concurrent other bladder pathology.
- •4. The patient has an indwelling catheter.
- •5. The patient has coexisting myaesthenia gravis.
- •6. The patient has a persistent urinary infection or un-investigated haematuria (if patients are diagnosed with a urinary tract infection at screening, part 2 of the screening assessments will be postponed until the infection had resolved).
- •7. The patient has a history of blood clotting disorders, or is on warfarin.
- •8. The patient has any other serious illness or medical condition that in the opinion of the investigator would jeopardise the efficacy or safety of this treatment or of the study assessments.
- •9. The patient has any contraindication to the use of Botulinum toxin (any serotype).
- •10. The patient has a known allergy or hypersensitivity to clostridium botulinum neurotoxin complex or to any of the excipients.
- •11. The patient is pregnant or lactating. Female patients of child-bearing potential (i.e. who are not surgically sterile or < 1 year post-last menstrual period) must have a negative pregnancy test on the day of injection.
- •12. The patient is a female at risk of pregnancy during the study, not taking adequate precautions against pregnancy.
- •13. The patient is receiving anticholinergic medication for which the dose has not been stable for at least 12 weeks prior to the baseline visit.
- •14. The patient is currently treated with, or has been treated during the week prior to the study with medications that affect neuromuscular transmission, such as curare-like depolarizing agents, lincosamides, polymyxins, anticholinesterases and aminoglycoside antibiotics.
- •15. The patient has received any investigational drug therapy within 30 days prior to the study, or is scheduled to receive such a drug during the study period.
- •16. The patient has previously entered this study.
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