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临床试验/NCT01048177
NCT01048177撤回2 期

A Trial of Intravesical Therapy for Interstitial Cystitis in Patients With Generalized Vulvodynia

Scripps Health1 个研究点 分布在 1 个国家开始时间: 2012年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
撤回
试验地点
1
主要终点
Reduction in pelvic pain / vulvodynia

研究概览

简要总结

In order to investigate whether the pain in women with vulvodynia may represent bladder origin pain, we will be performing a diagnostic test for interstitial cystitis (IC) in women with generalized vulvodynia. Those women with a positive test for IC, we will be performing a series of bladder treatments (instillations) for IC and checking symptoms throughout the trial to see if significant relief of vulvar pain can be obtained through treatment for IC.

详细描述

A TRIAL OF INTRAVESICAL THERAPY FOR INTERSTITIAL CYSTITIS IN PATIENTS WITH GENERALIZED VULVODYNIA

BACKGROUND:

Interstitial Cystitis (IC) is a urologic pain syndrome. The classic symptoms of IC are frequency, urgency and pain (dysuria) in the absence of an infection or other obvious source. IC has also been described as a visceral pain syndrome. In recent years, less common presentations of IC have been reported in women with primary symptoms of gynecologic pain such as endometriosis, dysparunia and vulvodynia1. This aim of this study is to further characterize the relationship between vulvodynia and IC and to see if a brief course of initial therapy for IC can relieve symptoms of generalized vulvodynia (GV)

The diagnostic criteria for IC, agreed to in the mid 1980's at an NIDDK conference, was developed for research purposes. These criteria require cystoscopy with hydrodistention in the operating room under general anesthesia. There also are multiple exclusionary criteria for diagnosis which limit its utility. The end result is that up to 60% of cases of IC can be missed using NIDDK criteria for the diagnosis of IC2. Because of these limitations, cystoscopy is now used less often for diagnosis.

In recent years, the potassium sensitivity test (PST) and the "anesthetic challenge" have been developed as alternative tests for the diagnosis of IC. These newer diagnostic techniques are less invasive and less painful than cystoscopy with hydrodistention, and are now fairly well accepted for diagnosis.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • We plan to enroll women 18 years or older with GV and negative tests for urine infection, negative cultures for Chlamydia and gonorrhea when indicated, and negative screens or cultures for yeast infection or bacterial vaginosis when indicated.
  • Patient symptoms will need to include no or minimal vaginal discharge.
  • Patients will have a minimum Visual Analog Score for vulvar pain of at least 3/
  • In order to receive bladder instillations, patients will need to have a positive potassium sensitivity test.

排除标准

  • We will exclude patients from enrollment if they use chronic narcotic pain medication or have localized vulvodynia. (We believe that localize vulvodynia is less likely of bladder origin).

研究组 & 干预措施

Treatment

Experimental

干预措施: Bladder instillation with heparin/ lidocaine (Drug)

结局指标

主要结局

Reduction in pelvic pain / vulvodynia

时间窗: 16 weeks

次要结局

未报告次要终点

研究者

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

Bruce Kahn

MD

Scripps Health

研究点 (1)

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