Efficacy and Safety of Submucosal Intravesical Injection of Platelet-rich Plasma in the Treatment of Interstitial Cystitis/Painful Bladder Syndrome
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Global Response Assessment (GRA) at 6 months after the PRP injection.
研究概览
简要总结
Interstitial cystitis/painful bladder syndrome (IC/PBS) is characterized by a constellation of bladder symptoms, including urinary frequency, urgency, nocturia, and pelvic pain.
Current intravesical IC/PBS treatment strategies include substances injected submucosally such as botulinum toxin A (BoNTA), or installed intravesically such as bacillus Calmette-Guerin (BCG), resiniferatoxin (RTX), lidocaine, chondroitin sulfate (CS), oxybutynin, and pentosan polysulfate (PPS).
Plasma Rich Protein (PRP) is rich in growth factors, such as platelet-derived growth factor, epidermal growth factor, and transforming growth factor. With the help of these growth factors the defective epithelium can undergo proliferation, differentiation, and wound healing.
详细描述
A Prospective clinical trial to assess the effectiveness of submucosal intravesical injection of autologous platelet-rich plasma in the treatment of IC/PBS resistant to conventional methods of treatment. It was held in the hospitals of Ain Shams University.
after meeting inclusion and exclusion criteria and attaining the written consent from the patients, they were submitted to intravesical injection of PRP.
All procedures were performed under spinal or general anaesthesia and all patients had received a third generation cephalosporin at the induction of anaesthesia.
Patients received 20 submucosal injections of PRP solution, each injection site receives 0.5 mL PRP. The injection needle was inserted about 1 mm into the at the posterior and lateral walls of the bladder, using a 23 gauge needle and 22 F rigid cystoscope.
After the PRP was injected, a 16 Fr urethral Foley catheter was left for one night to monitor the urine colour and patients were discharged on the next day. Oral antibiotics were prescribed for 3 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •History of symptoms of bladder pain/discomfort related to bladder filling and accompanied by other symptoms such as frequency and urgency.
- •The symptoms are lasting for not less than 6 months.
- •Failed medical treatment in the form of IC/PBS symptoms not relieved by antimicrobials, anticholinergics or antispasmodics after 6 months.
排除标准
- •Pregnancy or lactation.
- •Prior therapy with intravesical treatment.
- •Incomplete medical therapy (Receiving therapy for <3 months with antidepressants, anti-histaminics, hormonal agonists or antagonists).
- •Previous bladder or pelvic surgery or procedure having affected the bladder function.
- •Urodynamic study showing detrusor overactivity.
- •Elevated serum Prostatic Specific Antigen (PSA) level in males
- •Other causes of IC/PBS symptoms including :
- •i) Urinary bladder malignancy: bladder masses shown by ultrasonography or malignant cells by urine cytology.
- •ii) Indwelling catheters. iii) Infection: urinary tract infection, sexually transmitted disease and vaginitis.
- •iv) Chronic bacterial prostatitis. v) Chemical, tuberculous or radiation cystitis. vi) Bladder or lower ureteral calculi by non-contrast computed tomography (CT). vii) Pelvic organ prolapse (POP) by POP-Q assessment system. viii) Bladder outlet obstruction (BOO) diagnosed by urodynamic study.
研究组 & 干预措施
Intravesical PRP injection
Patients will receive 20 submucosal injections of PRP solution, each injection site receives 0.5 mL PRP. The injection needle will be inserted about 1 mm into the at the posterior and lateral walls of the bladder, using a 23 gauge needle and 22 F rigid cystoscope.
干预措施: Intravesical injection of Platlet Rich Plasma (PRP) (Drug)
结局指标
主要结局
Global Response Assessment (GRA) at 6 months after the PRP injection.
时间窗: at 1, 3, 6 months
The GRA is a seven-point symmetric scale used with the following possible responses: markedly worse (-3), moderately worse (-2), slightly worse (-1), no change (0), slightly improved (+1), moderately improved (+2), and markedly improved (+3). The result was considered as excellent when patients reported improvement in the GRA by \>2 and improved if there is improvement in the GRA by =1
Visual Analogue Scale (VAS)
时间窗: 1, 3, 6 months
Visual analogue scale is a uni-dimensional measure of pain intensity, used to record patient's pain progression, or compare pain severity between patients with similar conditions. We used a straight horizontal line of fixed length (100 mm), divided into 5 points starting from 0. No pain, 1. Slight discomfort, 2. Bearable pain, 3. Strong Pain and 4. Agonizing unbearable pain. The result was considered as excellent when patients reported no bladder pain (VAS = 0). The outcome was considered improved if pain VAS score reduced by 2 points on the scale.
次要结局
- urinary tract infection(after hospital discharge by 48 hours.)
- Macroscopic hematuria(first postoperative day)
研究者
Younan Ramsis
Lecturer
Ain Shams University