NL-OMON31587已完成2 期
Botulinum toxin A intravesical injections in the treatment of Bladder Pain Syndrome/ Interstitial Cystitis. - Bladder Pain Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Males and females aged 18 years, or older
- •- Subject has BPS/IC for a period of at least 9 months prior to screening, as determined by patient history:
- •- patient had cystoscopy with hydrodistension and cold biopsy
- •- patient has used oral medication: anticholinergic, NSAID and
- •tricyclic antidepressant
- •- patient has used intravesical instillations with cystistat, or ura-cyst, or
- •bladder cocktails, or heparin, or oxybutinin
- •- Subject has Visual Analog Scale (VAS) more than 5
- •- Subject has daytime voiding frequency more than 7
- •- Subject has night-time voiding frequency more than 2
- •- Those subjects taking anticholinergic medication, NSAID or tricyclic antidepressant use a stable dose and they are willing to maintain the dose during the study
- •- Patients must be willing to use clean intermittent catheterization to empty the bladder
排除标准
- •- Patient is pregnant, or patients who want to become pregnant during the study
- •- Patient has an active urinary tract infection or recurrent urinary tract infections
- •(> 5 urinary tract infections a year)
- •- Patient has a chronic or bacterial prostatitis
- •- Patient has a vaginitis
- •- Patient has an active sexually transmitted diseases
- •- Patient has urolithiasis
- •- Patient has an urethra or bladder diverticulum
- •- Patient has carcinoma of the uterus, cervix, vagina, urethra or prostate
- •- Patient has carcinoma in situ / malignancy of the bladder
- •- Patient has chemical-, tuberculous- or radiation cystitis
- •- Patient has hemophilia or other clotting factor deficiencies or disorders that cause bleeding diatheses.
- •- Patient has any medical condition that may put the patient at increased risk with exposure to BTX-A including diagnosed myasthenia gravis, Eaton Lambert syndrome or amyotrophic lateral sclerosis
- •- Patient discontinued anticholinergic, NSAID or antidepressant medication for bladder pain < 14 days prior to screening
- •- Patient using intravesical instillations, or used it 4 weeks prior to screening
- •- Patient using neuromodulations devices for treatment of BPS/IC
- •- Patient is breastfeeding
- •- Patient has a post void residual volume above 200 ml
- •- Patients who will use neuromuscular blocking agents in the period of three days before until eight weeks after study treatment
- •- Patients who will use aminoglycoside antibiotics the period of three days before until eight weeks after study treatment
研究者
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Botulinum toxin A intravesical injections in the treatment of Bladder Pain Syndrome/Interstitial CystitisInterstitial Cystitis (IC) is a syndrome characterized by bladder pain associated with urgency, frequency, nocturia, dysuria and sterile urine. The patho-physiology remains largely unclear. No universally, effective, treatment exists. Botulinum toxin-A (BTX-A) inhibits the release of acetylcholine at the presynaptic cholinergic junction resulting in temporally muscle relaxation and bladder desensitisation. We explore the effects of intravesical injections with BTX-A in the treatment of IC.EUCTR2007-005164-27-NLresearch office urology VUmc12
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