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临床试验/NCT00823030
NCT00823030撤回不适用

Effect of Intravesical Lidocaine on Urodynamic and Symptomatic Parameters of Interstitial Cystitis

Northwell Health1 个研究点 分布在 1 个国家开始时间: 2009年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Urodynamic parameters

研究概览

简要总结

The purpose of this study is to determine the amount of improvement in bladder function and pain relief with the administration of 2% alkalinized lidocaine in patients with interstitial cystitis. Specifically, we want to see if the administration of 2% alkalinized lidocaine treatments in the bladder improves urodynamic test result values. We hope to enroll approximately 40 patients in this study.

Previous research has shown that the administration of 2% alkalinized lidocaine in the bladder may improve the bladder's capacity to hold urine and urine flow rates while simultaneously providing pain relief. As part of standard of care at the Smith Institute of Urology Pelvic Pain Center, we routinely offer our IC patients 2% alkalinized lidocaine with follow up urodynamic evaluation. Our research looks to expand upon the prior studies and confirm the findings of improved bladder function and enhanced pain control of 2% alkalinized lidocaine versus placebo by performing a second urodynamic evaluation, which is not routinely performed.

详细描述

Interstitial cystitis (IC) is a chronic bladder condition that includes symptoms of bladder or pelvic pain as well as irritative voiding symptoms (urgency, frequency, nocturia, dysuria). The syndrome is usually diagnosed clinically after ruling out any possible infectious or neoplastic causes. Due to the lack of standardized diagnostic criteria, the reported prevalence of IC in the United States varies widely from 35 to 24,000 per 100,000 persons1,2. Regardless, there is no doubt that IC is a source of much distress and profoundly affects quality of life. IC patients have been reported to have lower quality of life than dialysis patients. They are 6 times more likely than the general population to cut down on work time owing to health problems and have higher reported incidences of depression, chronic pain, anxiety and overall mental health2,

The exact pathophysiology or etiology of IC is not completely understood but there have been much advancement in knowledge. The etiology is most likely multifactorial and studies have shown a role for epithelial dysfunction, inflammatory events as well as neurological dysfunction [Figure 1]. An initiating event such as infection, trauma, or autoimmune disorder leads to dysfunctional urothelium4. Activation and upregulation of sensory nerves occurs, leading to mast cell activation and release of histamine and other mediators5,6. This, in turn, leads to a cycle of symptoms for the IC patient.

Due to the multifactorial nature of its pathogenesis, IC treatment is complicated and involves multimodal treatments that target different factors. Tricyclic antidepressants control the regulation and activation of the nerves7. Antihistamines target mast cell activation8 while heparinoids such as pentosan polysulfate sodium (PPS) or heparin targets the dysfunction epithelium. Heparin is one of the most commonly used intravesical agent for the treatment of IC. It has been found to be effective is almost 50% of patients9. While heparinoid therapy enhances the barrier effect of the disrupted urothelium, it does not directly target the sensory nerves of the bladder. Hence, it may take more than 2 years of treatment for severely affected patients to feel any symptomatic relief10. Furthermore, once symptomatic relief is achieved, it is not sustained for very long11. Urologists aimed to develop therapy that would directly affect the sensory nerves of the bladder and provide immediate symptomatic relief.

The use of intravesical lidocaine in severe IC was first reported in Sweden in 1989. Asklin et al., reported on one patient who received repeated intravesical instillations of lidocaine and achieved much relief13. Success with the treatment was subsequently reported for another patient in 199214. Surprisingly, there have been very few studies on the clinical efficacy of intravesical lidocaine in IC patients since then. To date, all studies involving intravesical lidocaine lack randomization or a control group. It is difficult to determine the influence of any existing placebo effect of intravesical instillations.

One such study was conducted in 2005 by Parsons et al., which tested the efficacy of heparin combined with intravesical lidocaine in 47 newly diagnosed IC patients. 75% of patients reported significant improvement in symptoms after just one instillation with symptomatic relief lasting at least 4 hours. Significant improvement in symptoms was reported in 94% of patients who received a second instillation using a higher concentration of lidocaine. Of 20 patients who received a course of 6 instillations over 2 weeks, 80% reported sustained relief15.

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
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female patients aged ≥ 18
  • Clinical diagnosis of Interstitial cystitis based on the National Institute of Diabetes, Digestive and Kidney Diseases (NIDKK) criteria. According the NDIKK criteria, IC patients must have either glomerulations on cystoscopic examination or classic Hunner Ulcers and must also have either pain associated with the bladder or urinary urgency. Symptoms of abnormal urinary frequency and bladder pain/discomfort must have been present for at least 3 months prior to study entry
  • Able to understand and complete a VAS/GRA/modified IPSS assessment
  • Written informed consent

排除标准

  • Currently asymptomatic
  • Severely debilitating or urgent concurrent medical condition
  • History of pelvic radiation therapy, tuberculous cystitis, neurologic disease affecting bladder function, bladder cancer, or carcinoma in situ, or urethral cancer
  • Presence of bladder, urethral, or ureteral calculi
  • Clinical evidence of urethritis
  • Unlikely to be compliant due to unmanaged medical or psychological problem, including neurological, psychological or speech/language problems that will interfere with ability to complete the study
  • Allergy to lidocaine or any of the other anesthetics in the amide family.

研究组 & 干预措施

Placebo

Placebo Comparator

Placebo instillation: 20 ml of normal saline instilled intravesically

干预措施: Urodynamic study (Procedure)

Placebo

Placebo Comparator

Placebo instillation: 20 ml of normal saline instilled intravesically

干预措施: Normal Saline (Other)

experimental arm

Experimental

The experimental instillation will include 8 ml of 2% lidocaine, 3 ml of sodium bicarbonate, and 9 ml of normal saline.

干预措施: Urodynamic study (Procedure)

experimental arm

Experimental

The experimental instillation will include 8 ml of 2% lidocaine, 3 ml of sodium bicarbonate, and 9 ml of normal saline.

干预措施: Lidocaine (Drug)

结局指标

主要结局

Urodynamic parameters

时间窗: 2 hours, 1 baseline UDS will be checked and then another will be checked one hour after the interventional step

次要结局

  • symptom scores (Global response assessment, IPSS, VAS)(baseline, after 2nd UDS, and at 3 and 7 days after the procedure)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Robert Moldwin

principal investigator

Northwell Health

研究点 (1)

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