Lessons on Urethral Lidocaine in Urodynamics (LULU): Impact of Intraurethral Lidocaine on Cystometric Parameters and Discomfort
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Sensation as Indicated by the Volume of Water Filled (ml) at the Time of Patient Perception of First Sensation, First Urge to Void, Strong Urge to Void, and Full Bladder Capacity During Bladder Filling.
研究概览
简要总结
This trial will assess whether use of intraurethral 2% lidocaine jelly meaningfully impacts sensation during filling (i.e., a change of more than 25% of first sensation, first desire to void, strong desire to void, or maximum cystometric capacity) and determine whether the use of intraurethral 2% lidocaine jelly meaningfully impacts pain/discomfort, filling metrics, and voiding metrics.
详细描述
This trial is a randomized, double blind, controlled trial for patients undergoing complex cystometric evaluation. Patients will undergo routine complex cystometric evaluation for acquisition of baseline data using a small amount of intraurethral aqueous jelly for catheter lubrication. Then, they will be randomized to instillation of either placebo (additional intraurethral aqueous jelly, 5ml) or intraurethral 2% lidocaine jelly. Participants then undergo complex cystometry a second time. Normal variations in studies with placebo will be compared to variations within the 2% lidocaine jelly group to determine if cystometric parameters are altered in any clinically important ways. Patient discomfort will also be evaluated by both the patient and the urodynamics advanced practice nurse.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Care Provider)
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
- •Female patients
- •>18 years of age
- •Already scheduled (or being scheduled) for UDS to assess urinary incontinence
- •Able to speak and read in English
排除标准
- •Diagnosis of pelvic pain, interstitial cystitis, or bladder pain syndrome
- •Known neurogenic disease impacting voiding/ continence (e.g., Parkinson disease, multiple sclerosis, myasthenia gravis, recent stroke)
- •Active UTI
- •Pelvic organ prolapse that is unable to be easily reduced
- •Pregnancy or breastfeeding
- •Allergy or hypersensitivity to lidocaine or local anesthetics
研究组 & 干预措施
Water Based Lubricating Jelly
5ml of Water Based Lubricating Jelly
干预措施: Water-Based Vaginal Lubricant (Drug)
Lidocaine 2% Jelly
5ml of Lidocaine 2% Jelly
干预措施: lidocaine topical (Drug)
结局指标
主要结局
Sensation as Indicated by the Volume of Water Filled (ml) at the Time of Patient Perception of First Sensation, First Urge to Void, Strong Urge to Void, and Full Bladder Capacity During Bladder Filling.
时间窗: Within same visit, approximately 90-120 minutes.
Assess whether use of intraurethral 2% lidocaine jelly meaningfully impacts sensation during filling (especially, strong desire to void).
次要结局
- Patient Perception of Pain/Discomfort as Indicated by Visual Analog Scale (Scale of 0-100 With 0 Being no Pain and 100 Being the Worst the Pain Imaginable).(Change from cystometrogram 1 to cystometrogram 2 within same visit, approximately 90-120 minutes.)
- Voiding Metrics: Percentage of Voiding Efficiency(Cystometrogram 2 within same visit, approximately 90-120 minutes.)
- Voiding Metrics: Voiding Pattern (Normal vs. Intermittent/Interrupted vs Prolonged) as Perceived by Provider Interpretation of Pressure Flow Study During Voiding Based on Seconds to Void and Whether Urine Stream is Constant or Intermittent/Interrupted.(within same visit, approximately 90-120 minutes.)
- Voiding Metrics: Voided Volume and Post-void Residual(Within same visit, approximately 90-120 minutes.)
- Voiding Metrics: Pdet Peak Flow(Within same visit, approximately 90-120 minutes.)
- Voiding Metrics: Pdet Max(Within same visit, approximately 90-120 minutes.)
- Filling Metrics: Number of Participants With Detrusor Overactivity(Cystometrogram 2 within same visit, approximately 90-120 minutes.)
- Voiding Metrics: Maximum Flow Rate(Within same visit, approximately 90-120 minutes.)
- Provider Perception of Patient Pain/Discomfort as Indicated by Visual Analog Scale (Scale of 0-100 With 0 Being no Pain and 100 Being the Worst Pain Imaginable).(Change from cystometrogram 1 to cystometrogram 2 within same visit, approximately 90-120 minutes.)
- Filling Metrics: Number of Participants With Normal Bladder Compliance(Within same visit, approximately 90-120 minutes.)
研究者
Christina Hegan
Nurse practitioner
University of Texas Southwestern Medical Center