A Single-Arm Feasibility Study Evaluating the Safety and Potential Efficacy of Platelet-Rich Plasma (PRP) Therapy in Patients with Detrusor Underactivity (DUA)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Primary Outcomes:
研究概览
简要总结
The bladder’s function is to store and release urine. In some individuals, the bladder muscle becomes weak and cannot contract properly, leading to a condition called Detrusor Underactivity (DUA). This results in difficulty in emptying urine, urinary retention, and dependence on catheters for voiding. Current treatments such as intermittent catheterization or medications are only partially effective and carry risks like infections.
Platelet-Rich Plasma (PRP) is a biological product prepared from a person’s own blood, containing platelets that release multiple growth factors known to promote healing and regeneration of muscles and nerves. PRP has been successfully used in other medical fields to repair tissues but has limited research in bladder muscle repair.
In this study, we propose to use PRP therapy to improve bladder muscle function in patients with DUA. After taking a small blood sample from the participant, PRP will be prepared, activated, and injected into the bladder muscle through a minor cystoscopic procedure. This process will be done once, with a possible booster injection after 3 months if needed.
Participants will be followed up at 1, 3, 6, and 12 months to assess improvement in urination, bladder emptying, bladder pressures, symptom scores, and any side effects. No participant will be charged for participation, and all safety measures will be in place.
The goal of this study is to explore whether PRP therapy can provide a safer, less invasive regenerative treatment option for DUA patients, potentially improving their quality of life and reducing dependency on catheters.
Participation is voluntary, and patients can withdraw from the study at any time without affecting their routine medical care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients of detrusor underactivity.
排除标准
- •Active urinary tract infection Bladder malignancy Coagulopathy or platelet dysfunction disorders Pregnancy.
结局指标
主要结局
Primary Outcomes:
时间窗: measured at 1, 3, 6, and 12 months.
Improvement in detrusor contractility (measured as PdetMax maximum detrusor pressure on urodynamics)
时间窗: measured at 1, 3, 6, and 12 months.
Reduction in post-void residual (PVR) volume (mL) by MSCD/minimal significant clinical difference of at least 10% over previous value.
时间窗: measured at 1, 3, 6, and 12 months.
次要结局
- Improvement in patient reported symptoms (IPSS, VAS) MSCD/minimal significant clinical difference of at least 2 points in IPSS & one in VAS.(- Reduction in catheterization frequency by at least 2 .)
研究者
Satyadeo Sharma
All India Institute of Medical Sciences Raipur
