跳至主要内容
临床试验/NCT05226832
NCT05226832撤回不适用

Intradetrusor Triamcinolone Injection in the Management of Interstitial Cystitis/Bladder Pain Syndrome: Pilot Study

The University of Texas Medical Branch, Galveston0 个研究点开始时间: 2022年8月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
O'Leary-Sant Symptom Index; Problem Index; Pain, Urgency, Frequency Symptom Scale

研究概览

简要总结

This initial pilot project aims to study the use of FDA-approved 40mg triamcinolone injections in the bladder for the management of interstitial cystitis with or without Hunner's lesions. Intradetrusor triamcinolone injections are already the standard of care for IC patients with Hunner's lesions, but its role in management of IC without Hunner's lesions has yet to be determined. Triamcinolone is a long-acting corticosteroid that acts by inhibiting the migration of polymorphonuclear leukocytes, which may contribute to attenuation of inflammation in interstitial cystitis. We will recruit 27 females 18 years of age or older that have been diagnosed with IC/BPS. Patients will undergo a one-time cystoscopy along with the triamcinolone injections for IC management as a part of the research study. Validated questionnaires will be provided before the treatment to quantify symptoms at baseline and after treatment at follow-up visits. Follow up visits will occur in clinic every 4 to 6 weeks, which will continue for a maximum of 1 year. Scores at follow-up visits will be compared to baseline.

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 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients must meet an appropriate diagnosis of IC from NIDDK (National Institute of Diabetes and Digestive and Kidney Diseases)
  • Patients must be female
  • 18 years or older
  • Have an official diagnosis of Interstitial Cystitis/Bladder Pain Syndrome

排除标准

  • Patients who do not meet NIDDK inclusion criteria for Interstitial Cystitis as described above will not me enrolled in the study
  • The presence of urinary tract or sexually transmitted infection (may be included once existing infection is treated and cleared)
  • Pregnant women
  • Patients who have the inability to consent on their own behalf
  • Prisoners

结局指标

主要结局

O'Leary-Sant Symptom Index; Problem Index; Pain, Urgency, Frequency Symptom Scale

时间窗: One Year

Follow-up visits will occur every 4-to-6-weeks post-procedure as part of UTMB's standard of care. Patients will be asked to fill out The O'Leary-Sant Symptom Index and Problem Index and the Pain, Urgency, Frequency Symptom Scale to quantify symptoms, which is not experimental. No other procedures will occur for Visits #3 and onward. Follow-up visits will continue for a maximum of 1 year

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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