The Impact of Pre-procedure Periurethral Topical Lidocaine Application on Pain Scores After Complex Urodynamic Testing in Women
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- The change in patient visual analog pain score (vaginal area only) from before procedure to 4-6 hours after urodynamic testing
研究概览
简要总结
Urodynamic testing can be associated with mild discomfort, particularly at the time of insertion, repositioning, and removal of the bladder catheter (a tube inserted into the bladder via the urethra). Few studies have investigated ways to improve patient comfort during this procedure. In this study, the investigators want to see if applying external lidocaine (a numbing gel) prior to the procedure can help to minimize patient discomfort.
详细描述
Urodynamic testing can be associated with mild discomfort, particularly at the time of insertion, repositioning, and removal of the bladder catheter (a tube inserted into the bladder via the urethra). Few studies have investigated ways to improve patient comfort during this procedure. In this study, the investigators want to see if applying lidocaine (a numbing gel) prior to the procedure can help to minimize patient discomfort.
Participation in this study will involve only 1 clinic visit (for urodynamic testing), plus 2 phone calls to ask participants about pain (1 at 4-6 hours after testing; and 1 at 24 hours after testing). Additionally, the investigators will record any adverse effects (such as an allergic reaction to the gel or new irritation/pain) that happen within 2 weeks after testing.
Participants will be randomly assigned to receive either lidocaine gel or placebo gel for their urodynamic testing. The placebo gel will be a standard lubricant gel, meaning that it contains no active drug. The assigned study regimen will be chosen by chance, like flipping a coin. Participants will have an equal (50/50) chance of being given either study regimen. Neither the participant nor the study doctor or nurse practitioner will know which study regimen the participant is getting. Additionally, a member of the study team will ask participants about their pain level before and after the testing. The rest of the urodynamic testing procedure will take place exactly as it would if the participant was not in this research study.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All female patients between the ages of 40-80 undergoing urodynamic testing.
排除标准
- •Urinary tract infection or symptoms of infection at time of procedure or within past 2 weeks
- •History of urinary retention
- •Known or suggested history of urethral syndrome or painful bladder syndrome
- •Prior anti-incontinence surgery
- •Prior pelvic surgery with placement of transvaginal mesh
- •Known urethral or bladder anomaly including urethral diverticulum or congenital anomalies of the bladder or urethra
- •History of genital herpes outbreak within the past 3 months
- •Defects in mucosal surfaces including periurethral or vaginal abrasions, ulcerations, or lacerations
- •Neurologic disease affecting urethral sensation
- •Chronic pelvic pain
- •Contraindication or allergy to topical anesthetic
- •Pregnancy
- •Syncopal episode during preparation for or execution of uroflowometry
研究组 & 干预措施
Lidocaine gel
If assigned to this arm, participants have lidocaine gel 2% applied to their external urethra and vagina one time prior to the urodynamics procedure.
干预措施: Lidocaine gel 2% (Drug)
Lubricant gel
If assigned to this arm, participants will have a standard lubricant gel applied to their external urethra and vagina prior to the urodynamics procedure.
干预措施: Standard lubricant gel (Other)
结局指标
主要结局
The change in patient visual analog pain score (vaginal area only) from before procedure to 4-6 hours after urodynamic testing
时间窗: Baseline and 4-6 hours post procedure.
Participants will rate their pain according to a visual analog pain scale from 0 (no pain) to 100 (worst pain imaginable).
次要结局
- Urodynamic findings(At time of procedure.)
- Change in patient visual analog pain score (vaginal area only) from before procedure to 24 hours after urodynamic testing.(Baseline and 24 hours post procedure.)
- To assess voiding difficulties and other adverse events immediately after urodynamic testing, at 4-6 hours, 24 hours, and two weeks after urodynamic testing.(Baseline and 2 weeks post-procedure.)
- Procedure time(At time of procedure.)
- Patient visual analog pain score (vaginal area only) before procedure, at conclusion of all procedure-related activities, 4-6 hours after procedure, and 24 hours after procedure.(Baseline and 24 hours post procedure.)
研究者
charbel salamon
Principal Investigator
Atlantic Health System