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临床试验/NCT07016451
NCT07016451已完成1 期

Low-intensity Extracorporeal Shockwaves in the Treatment of Radiation Cystitis, Randomized Controlled Trial

Thanakrit Visuthikosol1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2024年4月2日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
25
试验地点
1
主要终点
Symptoms

研究概览

简要总结

Radiation-induced cystitis is a condition commonly seen in patients who have undergone radiation therapy, especially those treated in the pelvic region. Symptoms typically manifest after radiation exposure and may include dysuria (painful urination), increased urinary frequency during both day and night, and hematuria (blood in the urine), which can range from mild to severe.

Currently, treatment is symptomatic, as there is no definitive cure for radiation cystitis. Management includes medications to alleviate symptoms, cystoscopic interventions to control bleeding, intravesical instillations, and in severe cases, surgical procedures to divert the urinary tract.

Recently, low-intensity extracorporeal shock wave therapy (Li-ESWT) has been used to treat various urological conditions, including chronic prostatitis, chronic cystitis, overactive bladder, erectile dysfunction, and as an adjunct to enhance drug delivery into the bladder. This modality has shown potential to reduce inflammation, promote angiogenesis (formation of new blood vessels), regenerate tissues, and restore neural function.

For patients with radiation cystitis, particularly those with prostate cancer who have received pelvic radiation, shock wave therapy is being explored for its ability to alleviate bladder pain and inflammation. This approach is similar to its use in non-bacterial cystitis and overactive bladder conditions.

Studies have identified elevated levels of specific proteins in the urine of patients with radiation-induced cystitis, including markers of fibrosis, angiogenesis, and inflammation, which differ from those found in non-irradiated individuals.

The anticipated benefit of this study is to provide data on clinical symptoms and treatment safety, potentially offering a novel therapeutic strategy for managing radiation-induced cystitis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • •Criteria for diagnosis of radiation-induced cystitis and a history of pelvic radiation therapy administered more than 6 months prior.
  • •Aged 18 years or older.
  • •Willing to participate in the research study by providing written informed consent.

排除标准

  • •Active urinary tract infection within the past 6 months.
  • •Active and uncontrolled gross hematuria.
  • •Patients currently have a urinary diversion or abdominal ostomy.
  • •Patients with anuria due to chronic kidney failure.
  • •Uncontrolled coagulopathy.
  • •Refuse participation, withdraw from the study, or experience severe adverse effects.

研究组 & 干预措施

Control

Active Comparator

Patient receives the treatment, medication or intervention that not included Li-ESWT

干预措施: Medication (Drug)

Li-ESWT

Experimental

The intervention treatment for Radiation cystitis mainly or only uses Li-ESWT. If the patients have regular medication for this disease, they will receive continuous treatment

干预措施: Li-ESWT (Procedure)

Li-ESWT

Experimental

The intervention treatment for Radiation cystitis mainly or only uses Li-ESWT. If the patients have regular medication for this disease, they will receive continuous treatment

干预措施: Medication (Drug)

结局指标

主要结局

Symptoms

时间窗: Before, 1, and 3 months after treatment

In each study group, comparative analysis of symptoms such as urination frequency, nocturia, dysuria, and incontinence is conducted before and after treatment. Each parameter is recorded by the patient in a bladder diary, capturing the frequency and intensity of symptoms experienced daily for the preceding three days.

次要结局

  • Urine Molecular Analysis(Before, 1, and 3 months after treatment)

研究者

发起方
Thanakrit Visuthikosol
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Thanakrit Visuthikosol

Thanakrit Visuthikosol, MD

Ramathibodi Hospital

研究点 (1)

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