Intra-vesical Injection of Platelet-Rich Plasma Compared With Botox for Management of Patients With Refractory Overactive Bladder: A Comparative Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Change in Overactive Bladder Symptom Score (OABSS) from baseline
研究概览
简要总结
Overactive bladder is a common condition that causes sudden urges to urinate, frequent urination, night-time urination, and sometimes leakage of urine. Many people with overactive bladder improve with lifestyle changes and medicines. However, some patients do not respond to these standard treatments and continue to suffer from bothersome symptoms. This study is designed to help patients who have not improved with available medical therapy.
Two treatments will be compared in this research. The first treatment uses platelet-rich plasma. Platelet-rich plasma is made from a patient's own blood and contains growth factors that may help repair the lining of the bladder and improve bladder function. The second treatment uses botulinum toxin. Botulinum toxin is a protein that can reduce unwanted bladder contractions and is already approved for use in patients with overactive bladder who did not respond to other treatments.
The purpose of this study is to evaluate whether platelet-rich plasma injection into the bladder wall is safe, effective, and durable when compared with botulinum toxin injection into the bladder muscle. We believe that platelet-rich plasma may improve bladder health by encouraging tissue repair and reducing inflammation, while botulinum toxin may reduce bladder overactivity by blocking chemical signals that cause muscle contractions.
This study will take place at Benha University Hospital in Egypt. About 48 adult participants with overactive bladder that has not improved after at least six months of medical therapy will be enrolled. Participants will be randomly assigned to one of two groups. One group will receive platelet-rich plasma injections into the bladder lining, and the other group will receive botulinum toxin injections into the bladder muscle. The procedures will be performed under anesthesia using a cystoscope, which is a thin instrument inserted into the bladder.
Participants will be followed for one year. At several time points during follow-up, they will complete bladder symptom questionnaires, keep a voiding diary, and undergo urodynamic studies to measure bladder capacity and function. Researchers will also monitor safety by recording any side effects, such as urinary tract infections or temporary difficulty emptying the bladder.
The main goal of this study is to determine whether platelet-rich plasma can reduce symptoms of overactive bladder as effectively as botulinum toxin, with fewer side effects and longer-lasting results. If successful, platelet-rich plasma could offer a new treatment option for patients who continue to struggle with overactive bladder despite standard medical therapy.
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
- Single (Outcomes Assessor)
盲法说明
The study is single-blinded. The outcome assessors who evaluate bladder diaries, questionnaires, and urodynamic tests will be blinded to treatment assignment. Participants and treating physicians will be aware of the intervention due to differences in preparation and administration.
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
- •Age 18 years or older
- •History of urgency, frequency, nocturia, with or without urge urinary incontinence, lasting for at least 6 months
- •Failure of standard medical treatment (antimuscarinics, beta-3 adrenergic agonists, or other appropriate therapy) for at least 6 months
- •Willing and able to complete bladder diaries, questionnaires, and urodynamic testing
- •Provides informed consent
排除标准
- •Pregnancy or lactation
- •Previous intravesical biological therapy (e.g., platelet-rich plasma or botulinum toxin)
- •Prior pelvic or bladder surgery that may affect bladder function
- •Active urinary tract infection or sexually transmitted infection
- •Vaginitis or chronic bacterial prostatitis
- •Bladder or lower ureteral stones confirmed by imaging
- •Bladder outlet obstruction on urodynamic study
- •Bladder malignancy (mass on imaging or malignant cells on cytology)
- •Use of indwelling urinary catheter
- •Severe uncontrolled medical conditions (e.g., uncontrolled diabetes, advanced renal or hepatic impairment)
- •Known hypersensitivity to botulinum toxin or contraindication to platelet-rich plasma preparation (e.g., coagulopathy, inability to discontinue anticoagulation safely)
研究组 & 干预措施
Platelet-Rich Plasma Injection
Participants will receive intravesical platelet-rich plasma prepared from their own blood. Approximately 50 milliliters of venous blood will be processed with a two-step centrifugation protocol to concentrate platelets. Ten milliliters of platelet-rich plasma will be injected sub-urothelially at 20 sites (0.5 milliliters per site) in the posterior and lateral bladder walls under cystoscopic guidance with spinal or general anesthesia. A 16-French urethral catheter will be left overnight. A short oral antibiotic course will be given for three days.
干预措施: Platelet-Rich Plasma (Biological)
Botulinum Toxin Injection
Participants will receive intravesical injection of onabotulinumtoxinA. One hundred units of onabotulinumtoxinA will be reconstituted in 10 milliliters of saline and injected into the bladder detrusor muscle at 20 sites (0.5 milliliters per site), sparing the trigone, under cystoscopic guidance with spinal or general anesthesia. A 16-French urethral catheter will be left overnight. A short oral antibiotic course will be given for three days.
干预措施: Intravesical Botulinum Toxin Injection (Drug)
结局指标
主要结局
Change in Overactive Bladder Symptom Score (OABSS) from baseline
时间窗: Baseline and 6 months after intervention
The Overactive Bladder Symptom Score (OABSS) is a patient-reported questionnaire with 4 items: daytime frequency (0-2), night-time frequency (0-3), urgency (0-5), and urge urinary incontinence (0-5). The total score ranges from 0 to 15, with higher scores indicating more severe symptoms. The outcome measure is the change in total OABSS score from baseline to follow-up.
Change in Maximum Cystometric Capacity (MCC) from baseline
时间窗: Baseline and 6 months after intervention
Maximum cystometric capacity (MCC) is measured during urodynamic testing as the bladder volume at which the patient can no longer delay urination, experiences strong desire to void, or involuntary detrusor contractions occur. Higher values indicate improved bladder storage capacity. The outcome measure is the change in MCC (in milliliters) from baseline to follow-up.
次要结局
- Change in International Consultation on Incontinence Questionnaire-Overactive Bladder (ICIQ-OAB) score from baseline(Baseline, 3 months, 6 months, 9 months, and 12 months after intervention)
- Incidence of urinary tract infection after intervention(Up to 12 months after intervention)
- Incidence of urinary retention requiring catheterization(Up to 12 months after intervention)
- Incidence of hematuria following intervention(Within 7 days of intervention)
研究者
Tamer Abd El-Wahab Diab
Lecturer of Urology
Benha University