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临床试验/NCT06339645
NCT06339645尚未招募不适用

The Correlation of Safety and Effectiveness Between Intravesical Platelet-rich Plasma Injection in Patients With Interstitial Cystitis/Bladder-A Retrospective Study

Hualien Tzu Chi General Hospital1 个研究点 分布在 1 个国家目标入组 658 人开始时间: 2024年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
658
试验地点
1
主要终点
Global response assessment (GRA)

研究概览

简要总结

The correlation of safety and effectiveness between intravesical platelet-rich plasma injection in patients with interstitial cystitis/bladder-A retrospective study to evaluate the correlation of safety and effectiveness between intravesical platelet-rich plasma injection of IC/BPS, with age of at least 20-84 years old in Taiwan of either sex with IC/BPS symptoms and proven of IC by cystoscopic hydrodistention. Patients who meet all eligibility requirements for entry into the study of intravesical PRP injection.

详细描述

Introduction: Interstitial cystitis/bladder pain syndrome (IC/BPS) is a chronic inflammatory disease of the bladder characterized by symptoms such as frequency, urgency, nocturia, and lower abdominal pain. Despite being recognized for a hundred years, there has not been a definitive treatment method that can completely eliminate bladder inflammation. Various methods have been attempted, including bladder hydrodistention, anti-inflammatory drugs, steroid injections, and the use of bladder epithelial protectants such as Hyaluronic Acid. In recent years, the use of intravesical injection of botulinum toxin for the treatment of IC/BPS has emerged; however, none of these methods have achieved the goal of long-term cure. Therefore, achieving remission of interstitial cystitis has been a persistent goal for urologists.

Platelet-rich plasma (PRP) therapy has emerged as a novel treatment modality in the past one to two decades, widely used for degenerative joint diseases and muscle injuries. This therapy involves extracting high concentrations of platelets mixed with serum from the patient's own blood, excluding red and white blood cells, and injecting this high-concentration platelet serum into the affected area. This exploits the various growth factors and cytokines abundant in platelets to promote wound healing and reduce chronic inflammation. PRP has shown promising results in many sports injuries and degenerative joint diseases over the past decade. As PRP is derived from the patient's own blood, it does not induce allergic reactions or produce any side effects.

PRP has been previously shown to effectively improve epithelial dysfunction and chronic inflammation in IC/BPS. We hope PRP injection can gradually eliminate inflammation within the bladder, and its various growth factors can facilitate the repair of damaged bladder epithelium. If this treatment proves effective, it could offer a better therapeutic option for many patients suffering from bladder symptoms due to interstitial cystitis.

Several patients have been enrolled since the initiation of clinical trials using intravesical injection of platelet-rich plasma for bladder treatment in 2016. However, data collection has been limited to single clinical trial studies. PRP has gradually become a routine treatment for patients with IC/BPS. Therefore, this study aims to comprehensively review the medical records of all patients who have received bladder PRP injections to clarify and understand the basic information and clinical examination data of patients with interstitial cystitis who have received bladder PRP injections from the past to the present.

Aim: This study also aims to understand interstitial cystitis further and investigate the safety and efficacy of bladder PRP injections for patients with interstitial cystitis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

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

入选标准

  • NIDDK criteria diagnostic IC/BPS, and received the intravesical PRP injection before

排除标准

  • non-IC/BPS patients
  • psychological disease was diagnosed
  • non-NIDDK criteria (Hunner's ulcer type)
  • Under-primary or illiterate respondents
  • patients with severe cardiopulmonary disease and such as congestive heart failure, arrhythmia, poorly controlled hypertension, not able to receive regular follow up
  • Patients with bladder outlet obstruction on enrollment
  • Patients with post-void residual > 150ml
  • Patients with an uncontrolled confirmed diagnosis of acute urinary tract infection
  • Patients have laboratory abnormalities at screening
  • Patients who cannot used urinary catheter to treat.
  • Female patients who are pregnant, lactating, or childbearing potential without contraception.
  • Patients with any other serious disease considered by the investigator not in the condition to enter the trial
  • Patients cannot record the voiding diary

结局指标

主要结局

Global response assessment (GRA)

时间窗: 6 months

satisfaction by the patient (categorized into -3, -2,-1, 0, +1, +2, +3, indicating markedly worse to markedly improved ) after the treatment day

次要结局

未报告次要终点

研究者

发起方
Hualien Tzu Chi General Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Wan Ru Yu

PI

Hualien Tzu Chi General Hospital

研究点 (1)

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