A Pilot Study to Determine the Role of Toll-like Receptor-4 Expression in Patients With Interstitial Cystitis/Bladder Pain Syndrome
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Toll-like Receptor 4 protein analysis
研究概览
简要总结
This is a prospective pilot study, with a recruitment goal of 60 patients. Patients who are female, above the age of 18, and with a diagnosis of IC/BPS based on clinical criteria and O'Leary Sant ICPI and ICSI scores undergoing cystoscopy, hydrodistention and bladder biopsy will be included. The bladder biopsies will be evaluated for TLR4 expression, and sent for histological assessment of mast cell count. Additionally, data will be collected at baseline, day of surgery, day 7, day 14 and day 28. Data will include validated questionnaires, lower urinary tract symptoms, and recorded pain medication use.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients must be a candidate for cystoscopy, hydrodistention and bladder biopsy.
- •Participant must have subjective complaints of
- •urinary urgency, relieved with voiding, OR
- •urinary frequency; ≥ 8 voids per day, OR
- •pelvic pain, pressure, or discomfort
- •Gender of subjects: Subjects in this study will be female. Pregnant women and breastfeeding women will be excluded due to unknown risk of study medication on pregnancy and fetus or nursing infants.
- •Age of subjects: Age of subjects will range from 18 to 90 years.
- •Racial and ethnic origin: There are no enrollment restrictions based upon race or ethnic origin. The racial and ethnic distribution of subjects is entirely based on the population of patients at the study site.
- •Other inclusion criteria:
- •Participant must give written informed consent to participate in the study
- •Participant must be able to make decisions for herself
- •Participant must not have had a UTI within 7 days prior to start of the study
- •Female participants who are with a positive pregnancy test
排除标准
- •To participate in the study subjects must not meet any of the following criteria:
- •Participant is currently pregnant or breastfeeding
- •Participant has a positive urinary pregnancy test at the time of screening
- •Participant is currently or has been on antibiotic therapy with the last 7 days prior to the start of the study
- •Participant is currently in another trial
- •Participant has an active S3 nerve stimulator implanted or has PTNS
- •Participant has had intravesical botulinum toxin injection in 6 months prior to starting the study
- •Participant has grade III or IV pelvic organ prolapse
- •Participant has history of bladder cancer
- •Participant has a neurological disease including, but not limited to, multiple sclerosis, Parkinson's disease, Alzheimer's disease, spinal cord injury, brain injury, stroke or dementia
- •Participant has urinary frequency of less than 8 times/day
- •Participant has bladder or lower ureteral calculi
- •Participant has active genital herpes
- •Participant has urethral diverticulum
- •Participant has chemical cystitis
- •Participant has radiation or tuberculosis cystitis
结局指标
主要结局
Toll-like Receptor 4 protein analysis
时间窗: 1 year
Determine Toll-like Receptor 4 protein expression with western blot
Toll-like Receptor 4 mRNA expression in bladder biopsy
时间窗: 1 year
Determine Toll-like Receptor 4 mRNA expression with quantitative polymerase chain reaction
Toll-like Receptor 4 distribution and localization evaluation
时间窗: 1 year
Determine Toll-like Receptor 4 distribution and localization with immunohistochemistry
次要结局
- Bladder symptom evaluation(28 days)
- Vaginal symptoms evaluation(28 days)
- Female sexual function(28 days)
- Interstitial cystitis Flares(28 days)
- Patient satisfaction(28 days)
研究者
Kristene Whitmore
Division Head of Female Pelvic Medicine and Reconstructive Surgery
Philadelphia Urosurgical Associates