Reduction of Bladder Injection Pain With Belladonna Opiate Suppository: A Randomized, Double-Blind, Placebo-Controlled Trial (ROBIN Trial)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Change in Bladder Injection Pain
研究概览
简要总结
The purpose of this study is to test whether using belladonna & opiate suppositories (B&Os) can improve patient discomfort during Onabotulinumtoxin A (BoNT) injection into the bladder for treatment of overactive bladder, neurogenic detrusor overactivity, or interstitial cystitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Met clinical criteria under outside care or during the Principal Investigator's routine standard of care for BoNT injection therapy
- •No contraindication to BoNT therapy as outlined by drug manufacturer guidelines
- •Participants have elected to have the BoNT injection therapy prior to being offered enrollment into the study for either overactive bladder (OAB), neurogenic detrusor overactivity (NDO), or refractory interstitial cystitis (IC)
排除标准
- •Currently pregnant
- •Currently nursing a baby
- •Anticipated geographic relocation within the first 3 months following treatment
- •Allergy to morphine, belladonna, or opiates
- •Patients will be excluded if participating in another research study
- •Individuals unable to provide informed consent or to complete two-week follow-up bladder testing (post-void residual) or data collection will also be excluded
研究组 & 干预措施
Active B&O suppository of belladonna
Receive the B&O suppository (belladonna/morphine) 40 minutes prior to Onabotulinumtoxin A (BoNT) injection procedure in conjunction with local analgesia.
干预措施: Onabotulinumtoxin A (BoNT) (Drug)
Active B&O suppository of belladonna
Receive the B&O suppository (belladonna/morphine) 40 minutes prior to Onabotulinumtoxin A (BoNT) injection procedure in conjunction with local analgesia.
干预措施: belladonna (Drug)
Active B&O suppository of belladonna
Receive the B&O suppository (belladonna/morphine) 40 minutes prior to Onabotulinumtoxin A (BoNT) injection procedure in conjunction with local analgesia.
干预措施: Morphine (Drug)
Active B&O suppository of belladonna
Receive the B&O suppository (belladonna/morphine) 40 minutes prior to Onabotulinumtoxin A (BoNT) injection procedure in conjunction with local analgesia.
干预措施: Active B&O suppository of belladonna (Drug)
Placebo suppository
Receive a placebo suppository 40 minutes prior to Onabotulinumtoxin A (BoNT) injection procedure in conjunction with local analgesia.
干预措施: Onabotulinumtoxin A (BoNT) (Drug)
Placebo suppository
Receive a placebo suppository 40 minutes prior to Onabotulinumtoxin A (BoNT) injection procedure in conjunction with local analgesia.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Bladder Injection Pain
时间窗: Baseline and intraoperative
The primary outcome will be calculated difference in numeric rating scale (NRS) pain score prior to procedure and midway through procedure. Scale is one question and has a range from a score of 0 (no pain) to 10 (worst possible pain). Measure will be reported as the intraoperative pain score minus the preoperative pain score.
次要结局
- Postoperative Voiding Trial Results(Postoperative (before leaving the clinic, within 3 hours of the end of the BoNT procedure))
- Number of Participants Declining to Complete Procedure Due to Pain Intolerance(Intraoperative)
- Post Void Residual (PVR)(2 Weeks)
- Pre-analgesia Pain Score(Baseline)
- Number of Participants With Evidence of Infection or Positive Urine Culture(2 Weeks)
- Post-operative Pain Score(Postoperative (within 10 minutes of the end of the BoNT procedure))
- Participant Satisfaction With Pain Control(Postoperative (within 10 minutes of the end of the BoNT procedure))
研究者
Edgar LeClaire, MD
Clinical Instructor
University of Kansas Medical Center