Assessment of Role of Platelet Rich Plasma in Managing Women with Mixed Urinary Incontinence
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Number of females with treatment-related improvement of mixed urinary incontinence after receiving platelet-rich plasma (PRP) injection and instillation.
研究概览
简要总结
The goal of this clinical trial is to assess the efficacy of platelet-rich plasma (PRP) for the treatment of mixed urinary incontinence determine .The main question it aims to answer whether PRP is it safe and effective in managing mixed urinary incontinence? Researchers will assess efficacy of PRP in both stress and urgency incontinence treatment
Participants will:
- Undergo PRP injection in to mid urethra , and installation into bladder every 1 month for 3 month
- Visit the clinic once every 1 month for checkups and urodynamic study after 3 month, and 4 month after last installation
详细描述
All patients will be subjected to:
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An informed consent will be taken from every patient.
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Complete history taking:
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Personal history
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Any complaint.
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Past medical and past surgical history.
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Family history.
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Severity of incontinence by International consultation on incontinence questionnaire- short form (ICIQ-SF), OAB symptom score ,Cough stress test
*Complete physical examination.
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General examination: Vital signs (Blood pressure, Temperature, Heart rate, Respiratory rate).
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neurological examination: gait, perineal sensation, bulbocavernous reflex, cognitive status
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abdominal examination : distended bladder, masses , hernia, DRE
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Pelvic examination: vaginal atrophy, skin excoriation, vault examination, organ prolapse, pelvic floor muscle strength , cough test, Q tip test, Marshall test
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urodynamics done for documentation of detrusor overactivity before and after PRP installation after 3rd instillation and 4 m after last instillation
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patient is placed in the dorsal lithotomy position
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PRP is obtained from a sample of patients' blood drawn at the time of treatment
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A 30 cc venous blood draw will yield 3-5 cc of PRP
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The blood draw occurs with the addition of an anticoagulant, such as citrate dextrose A( .5 ml)to prevent platelet activation prior to its use
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in room temp 21-24 to avoid activation of platelet
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a specialized 'table top cold centrifuge' device to centrifugate the sample
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After centrifugation, each vial was confirmed to contain three layers from top to bottom, namely, the platelet pellet, gel, and red blood cells. The platelet pellet was remixed with the supernatant by inverting the tubes gently 5-10 times.
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A-PRP was injected into the anterior vaginal mucosa around the mid-urethral area, which was approximately 1 cm below the urethral meatus and had a depth of about 1.5 cm; 2 mL were injected underneath the mid-urethral area and 1.5 mL was injected on either side of the urethra
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10ml PRP used to instill intravesical for urgency urinary incontinence by urethral catheter
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patient received four injections of PRP at monthly intervals
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follow up done after 3rd instillation and 4 months after finishing injections
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follow up done by subjective symptoms as previous scoring system and objective by Urodynamics
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
- 20 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with MUI ( mild and moderate degree of stress incontinence)
- •Age between 20 to 60 years -
排除标准
- •intrinsic sphincteric deficiency (ISD)
- •Pregnancy
- •Acute and chronic infections
- •Chronic liver disease
- •Anti-coagulation therapy
- •History of malignancy
- •Under anti-platelet agent treatment
研究组 & 干预措施
PRP injection at midurethra with PRP instillation into urinary bladder
A-PRP was injected into the anterior vaginal mucosa around the mid-urethral area, which was approximately 1 cm below the urethral meatus and had a depth of about 1.5 cm; 2 mL were injected underneath the mid-urethral area and 1.5 mL was injected on either side of the urethra
*10ml PRP used to instill intravesical for urgency urinary incontinence by urethral catheter
干预措施: Platelet Rich Plasma (Biological)
结局指标
主要结局
Number of females with treatment-related improvement of mixed urinary incontinence after receiving platelet-rich plasma (PRP) injection and instillation.
时间窗: From enrollment to the end of intervention at 6 month "
Treatment -related improvement of urinary incontinence is assessed using: * International consultation on incontinence questionnaire- short form (ICIQ-SF). * OAB symptom score. * Cough stress test. * Urodynamics. 1. ICIQ-Sf questionnaire before and after treatment: Scoring scale: 0-21, minimum 0, maximum 21. A higher score indicates greater impairment from incontinence. 2. OAB symptom score: has a maximum score of 15 with more weight assigned to urgency and urgency incontinence than on frequency. Higher score indicates greater impairment from incontinence. 3. Urodynamics: for assessment of of detrusor over-activity before and after treatment.
次要结局
未报告次要终点