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