Botox (Botulinum Toxin A) as a Treatment for Interstitial Cystitis in Women: A Randomized Placebo Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- Chronic Prostatitis Symptom Index (CPSI-F)
研究概览
简要总结
Patients with interstitial cystitis have been well documented to have pelvic floor muscle tenderness as well as pain on bladder distension. Some investigators have even suggested that pelvic floor muscle pain is primarily the cause of bladder problems.
Botulinum toxin A causes muscle relaxation by inhibiting the acetylcholine release at the neuromuscular junction. It has been shown that this mechanism relieves pain in a number of muscle spasm-related syndromes.
Because, at present, there is little effective therapy available for patients with interstitial cystitis, the researchers want to determine if botulinum toxin A will relieve bladder and pelvic pain in these patients.
详细描述
Screening Visit:
After being screened by her medical provider, the patient will be given the opportunity to ask questions about the study. She will then be asked to read and sign the consent and then be randomized.
Then, for women of childbearing age, a pregnancy test will be done.
Next, we will ask the patient to fill out baseline study forms and she will be given a Voiding Diary. She will also be asked to provide a urine sample which will be processed for chemistry and culture.
Injection Visit:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women ages 18 and older
- •Diagnosis of interstitial cystitis
- •Subject has severity/stage of disease: at least 12 voids/day with the presence of pelvic pain
- •Ability to follow study instructions and likely to complete all required visits.
- •Negative urine pregnancy test on the day of treatment prior to the administration of study medication (for females of childbearing potential; if applicable)
排除标准
- •Use of any medications that might interfere with neuromuscular function
- •Any medical condition that may put the subject at increased risk with exposure to Botox including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other disorder that might interfere with neuromuscular function
- •Females who are pregnant, breast-feeding, or planning a pregnancy during the study or who think that they may be pregnant at the start of the study, or females of childbearing potential who are unable or unwilling to use a reliable form of contraception during the study
- •Known allergy or sensitivity to any of the components in the study medication
- •Concurrent participation in another investigational drug or device study, or participation in the 30 days immediately prior to study enrollment.
- •Stress incontinence
- •Urinary tract infection at time of enrollment
- •Overtly psychotic or suicidal
- •Pain from another source in the genital tract such as kidney stones or neoplasm
- •Having had radiation therapy
- •History of genitourinary tuberculosis
- •Neurological abnormalities such as stroke, brain tumors, spinal cord injury and Parkinson's or Alzheimer's disease
- •Currently taking antibiotics
研究组 & 干预措施
Botox injection
Subjects were injected with Botulinum toxin A in a mix of 50 U diluted in 2 cubic centimeters of normal saline. With the subjects in the dorsal lithotomy position, one injection of 25 international units was given into the bladder neck at the 3 o'clock position and another of 25 international units was given into the 9 o'clock position
干预措施: Botox (Drug)
Normal saline
Subjects were injected in the bladder neck with 1 cubic centimeter normal saline into the 3 o'clock and 6 o' clock positions in the perineum, while in the dorsal lithotomy position
干预措施: normal saline (Other)
结局指标
主要结局
Chronic Prostatitis Symptom Index (CPSI-F)
时间窗: 3 months
CPSI-F was adapted from the CPSI, in order to document the location of pain, with working pertinent to female anatomy. The CPSI-F was scored on a range of 0-83 (0-61 in the pain domain, 0-10 in the urination domain, 0-6 in the impact of symptoms domain, and 0-6 in the quality of life domain), with higher scores denoting worse symptoms.
次要结局
未报告次要终点