The Effect of Intravesical Lidocaine Solution Versus Placebo as Anesthesia Prior to Intravesical Injection of Onabotulinum Toxin A. A Randomized, Double-blind, Placebo Controlled Cross-over Study
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 100 mm Visual Analogue Scale (VAS) score
研究概览
简要总结
The purpose of this study is to investigate the effect of Lidocaine solution versus placebo (isotonic Sodium Chloride NaCl) disposed inside the urinary bladder as intravesical anesthesia prior to onabotulinum toxin A injections in the treatment of urgency urinary incontinence.
详细描述
The aim of the study is to investigate if bladder installed Lidocaine solution have an effect on reported pain during BTX-A injections compared to placebo.
The study participants will be recruited from the existing patient populations enrolled in the BTX-A program of the tertiary Urogynaecological Clinic of Herlev University Hospital.
The participants are randomized to:
- Active drug: Lidocaine Hydrochloride and Sodium hydrogen carbonate
- Placebo: Sodium Chloride
The study includes 5 study visits:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Region Hovedstadens Apotek, Herlev Hospital produces the Lidocaine solution and the matching placebo solution, performs the randomization, and packages the blinded dosing kits with the order of Lidocaine and placebo in a balanced design (50% Lidocaine at the first treatment). Participants will get consecutive randomization numbers, which specify the dosing kit. Neither the participant, the operator, or the healthcare professional interviewing the participant about her pain score know what solution the participant gets administered.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Alkalinized Lidocaine, then Placebo
Participants will have Lidocaine Hydrochloride 20 mg/ml, 20 ml and Sodium hydrogen carbonate 1 mmol/ml, 10 ml (ie a total of 30 ml) installed in the bladder for 15 minutes prior to the BTXA-injection procedure.
When signing up for the next BTXA-injection with a wash out period of minimum three months, participants will have the matching placebo containing Sodium Chloride 9 g/L, 20 ml and Sodium Chloride 9 g/L, 10 ml, a total of 30 ml installed in the bladder for 15 minutes prior to the BTXA-injection procedure.
干预措施: Alkalinized Lidocaine (Combination Product)
Alkalinized Lidocaine, then Placebo
Participants will have Lidocaine Hydrochloride 20 mg/ml, 20 ml and Sodium hydrogen carbonate 1 mmol/ml, 10 ml (ie a total of 30 ml) installed in the bladder for 15 minutes prior to the BTXA-injection procedure.
When signing up for the next BTXA-injection with a wash out period of minimum three months, participants will have the matching placebo containing Sodium Chloride 9 g/L, 20 ml and Sodium Chloride 9 g/L, 10 ml, a total of 30 ml installed in the bladder for 15 minutes prior to the BTXA-injection procedure.
干预措施: Placebo Sodium Chloride 0.9% Inj (Drug)
Placebo, then Alkalinized Lidocaine
Participants will have placebo containing Sodium Chloride 9 g/L, 20 ml and Sodium Chloride 9 g/L, 10 ml, a total of 30 ml installed in the bladder 15 minutes prior to the BTXA-injection procedure.
When signing up for the next BTXA-injection with a wash out period of minimum three months, participants will have Lidocaine Hydrochloride 20 mg/ml, 20 ml and Sodium hydrogen carbonate 1 mmol/ml, 10 ml (ie a total of 30 ml) installed in the bladder for 15 minutes prior to the BTXA-injection procedure.
干预措施: Alkalinized Lidocaine (Combination Product)
Placebo, then Alkalinized Lidocaine
Participants will have placebo containing Sodium Chloride 9 g/L, 20 ml and Sodium Chloride 9 g/L, 10 ml, a total of 30 ml installed in the bladder 15 minutes prior to the BTXA-injection procedure.
When signing up for the next BTXA-injection with a wash out period of minimum three months, participants will have Lidocaine Hydrochloride 20 mg/ml, 20 ml and Sodium hydrogen carbonate 1 mmol/ml, 10 ml (ie a total of 30 ml) installed in the bladder for 15 minutes prior to the BTXA-injection procedure.
干预措施: Placebo Sodium Chloride 0.9% Inj (Drug)
结局指标
主要结局
100 mm Visual Analogue Scale (VAS) score
时间窗: The participant is handed the VAS in paper form and asked to grade the intensity of pain according to the VAS by making a handwritten mark on the VAS immediately after the BTX-A injections
The maximum pain score reported by using VAS
次要结局
- Post-void residual requiring Clean Intermittent Catheterization (CIC)(Phone consultation one week after each treatment)
- Urinary tract infection (UTI)(Phone consultation one week after each treatment)
- Hematuria(Phone consultation one week after each treatment)
- 5-point rating scale(Phone consultation one week after each treatment)
研究者
Meryam El Issaoui
MD, PhD Student
Herlev and Gentofte Hospital