A Randomized Trial of Bladder Instillations Versus Onabotulinumtoxin A for Treatment of Interstitial Cystitis/Bladder Pain Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Change in O'Leary-Sant questionnaire scores from baseline between bladder instillation and intradetrusor onabotulinumtoxinA injection groups
研究概览
简要总结
Recognition of interstitial cystitis (IC)/bladder pain syndrome (BPS) is increasing. There is a dire need to develop effective treatment options for these patients as it manifests as more than a physical disease, affecting general and psychological health as well. Existing trials comparing varying bladder instillation formulations have not identified an optimal bladder instillation therapy, however existing studies support combined heparin and alkalinized lidocaine bladder instillation as an affordable and effective treatment for IC/BPS. Additionally, intradetrusor onabotulinumtoxinA injection has been well established for the treatment of overactive bladder (OAB), a constellation of symptoms similar to that of IC/BPS. OnabotulinumtoxinA has now come into the forefront for treatment of OAB due to its efficacy, safety profile, and absence of cognitive effects related to the previous mainstay anticholinergic treatment. While both bladder instillation and onabotulinumtoxinA therapy have been shown to be effective for treatment of IC/BPS, a direct comparison of these treatments has not been performed. We therefore designed a randomized controlled trial to compare the efficacy of heparin with alkalized local anesthetic bladder instillation versus intradetrusor onabotulinumtoxinA injection in treating IC/BPS symptoms.
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
- 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
- 否
入选标准
- •Females ≥ 18 years of age
- •O'Leary-Sant questionnaire score ≥ 6
- •Ability to follow study instructions and complete all required follow-up
排除标准
- •Contraindications and/or allergies to medications used
- •Known alternative diagnosis explaining bladder pain symptoms
- •Bladder instillation within the past 3 months
- •Intradetrusor onabotulinumtoxinA injection within the past 6 months
- •Use of ≥ 400 units of onabotulinumtoxinA in the last 3 months
- •Inability or unwillingness to self-catheterize
- •Post-void residual > 200mL
- •Concurrent procedural treatment (including hydrodistension, sacral neuromodulation)
- •Current use of vaginal pessary/devices
- •Untreated symptomatic prolapse > pelvic organ prolapse quantification system (POP-Q) stage 2
- •Females who are pregnant or planning a pregnancy during the study or who think that they may be pregnant at the start of the study and who are unwilling or unable to use a reliable form of contraception during the study
- •Inability to speak/read English
研究组 & 干预措施
Heparin & Alkalinized Lidocaine Bladder Instillation
Six weekly bladder instillations, each instillation consisting of 40,000 IU Heparin, 200mg lidocaine, 2ml 8.4% sodium bicarbonate, sterile water for a total volume 50 milliliters (mL).
干预措施: Heparin & Alkalinized Lidocaine Bladder Instillation (Drug)
Intradetrusor Onabotulinumtoxin A Injection
100 units onabotulinumtoxinA reconstituted in 10mL of injectable saline, injected in 20 sites with 0.5mL per injection along the posterior wall of the bladder above the trigone.
干预措施: Onabotulinum Toxin A (Drug)
结局指标
主要结局
Change in O'Leary-Sant questionnaire scores from baseline between bladder instillation and intradetrusor onabotulinumtoxinA injection groups
时间窗: Baseline, 8-10 weeks
Consists of O'Leary-Sant Symptom and Problem Index, total score 0-36.
次要结局
- Change in Female Sexual Distress Scale-Revised (FSDS-R) score between bladder instillation and intradetrusor onabotulinumtoxinA injection groups(Baseline, 4-6 weeks, 8-10 weeks)
- Change in bladder capacity between bladder instillation and intradetrusor onabotulinumtoxinA injection groups(Baseline, 4-6 weeks, 8-10 weeks)
- Incidence of adverse outcomes between bladder instillation and intradetrusor onabotulinumtoxinA injection groups(8-10 weeks)
- Patient perceptions of treatment between bladder instillation and intradetrusor onabotulinumtoxinA injection groups(6-9 months)
- Change in pain scores using the Defense and Veterans Pain Rating Scale (visual analog scale) between bladder instillation and intradetrusor onabotulinumtoxinA injection groups(Baseline, 4-6 weeks, 8-10 weeks, 6-9 months)
- Change in Female Sexual Function Index (FSFI) score between bladder instillation and intradetrusor onabotulinumtoxinA injection groups(Baseline, 4-6 weeks, 8-10 weeks)
- Incidence of re-treatment between bladder instillation and intradetrusor onabotulinumtoxinA injection groups(6-9 months)
- Change in O'Leary-Sant questionnaire scores from baseline between bladder instillation and intradetrusor onabotulinumtoxinA injection groups(Baseline, 4-6 weeks, 6-9 months)
- Change in 12-item Short Form Survey (SF-12) score between bladder instillation and intradetrusor onabotulinumtoxinA injection groups(Baseline, 4-6 weeks, 8-10 weeks)