Comparative Efficacy and Safety if Intravesical Botulinum Toxin A Versus Platelet-Rich Plasma in the Management of Refractory Overactive Bladder : A 2 Year Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Reduction in Urgency Urinary Incontinence Episodes
研究概览
简要总结
The goal of this clinical trial is to compare the efficacy and safety of intravesical Botulinum Toxin A versus intravesical Platelet-Rich Plasma (PRP) in adults with refractory overactive bladder who have not responded adequately to conventional medical treatment. The main questions it aims to answer are:
- Whether intravesical PRP is as effective as intravesical Botulinum Toxin A in improving overactive bladder symptoms.
- Whether intravesical PRP has a better safety profile and lower incidence of adverse events during the 2-year follow-up period.
Researchers will compare participants receiving intravesical Botulinum Toxin A with those receiving intravesical PRP to determine differences in symptom improvement, quality of life, urodynamic outcomes, and treatment-related adverse events.
Participants will:
- Receive either intravesical Botulinum Toxin A injection or intravesical Platelet-Rich Plasma injection.
- Undergo baseline clinical assessment, symptom evaluation, and urodynamic studies as indicated.
- Attend scheduled follow-up visits over a 2-year period.
- Complete validated questionnaires assessing overactive bladder symptoms and quality of life.
- Be monitored for treatment efficacy and any adverse events throughout the study.
详细描述
The purpose of this prospective randomized clinical trial is to compare the efficacy and safety of intravesical Platelet-Rich Plasma (PRP) injection with intravesical Botulinum Toxin A injection in adult patients with refractory overactive bladder (OAB) who have failed or were intolerant to conventional medical therapy. Overactive bladder is a chronic condition characterized by urinary urgency, usually accompanied by increased daytime frequency and nocturia, with or without urgency urinary incontinence, and has a significant negative impact on patients' quality of life.
Botulinum Toxin A is an established third-line treatment for refractory OAB; however, its use may be associated with adverse events such as urinary retention, increased post-void residual urine, and urinary tract infection. Platelet-Rich Plasma has recently emerged as a regenerative therapeutic option because of its anti-inflammatory and tissue-repair properties and may provide symptom improvement with fewer complications.
The primary objective of this study is to compare the improvement in overactive bladder symptoms between the two treatment groups over a 2-year follow-up period. Secondary objectives include comparing quality of life, urinary frequency, urgency episodes, urgency urinary incontinence episodes, nocturia, functional bladder capacity, post-void residual urine volume, patient satisfaction, durability of treatment response, and treatment-related adverse events.
Eligible participants will be randomly assigned to receive either intravesical Botulinum Toxin A injection or intravesical Platelet-Rich Plasma injection according to the study protocol. Baseline assessment will include medical history, physical examination, symptom evaluation using validated questionnaires, voiding diary, laboratory investigations, and other investigations as indicated. Participants will undergo scheduled follow-up visits throughout the 2-year study period to assess clinical response, monitor for adverse events, and evaluate the need for additional treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Adults aged ≥18 years
- •Diagnosis of refractory overactive bladder (OAB)
- •Failed at least 2 pharmacological therapies
- •Willing and able to provide informed consent
排除标准
- •Neurogenic bladder
- •Active urinary tract infection (UTI)
- •Pregnancy or lactation
- •Known allergy to botulinum toxin or any PRP components
- •History of pelvic radiation or bladder malignancy
- •Uncontrolled coagulopathy or bleeding disorder
结局指标
主要结局
Reduction in Urgency Urinary Incontinence Episodes
时间窗: Baseline, 3, 6, 12, and 24 months
Change from baseline in mean number of urgency urinary incontinence episodes per 24 hours, assessed by 3-day voiding diary at 3, 6, 12, and 24 months post-treatment.
次要结局
未报告次要终点
研究者
Mahmoud Mohamed Farag Ali
Associate professor
Benha University
