Peri-Urethral Injections of Platelet-Rich Plasma in Treatment of Post-Menopausal Female Stress Urinary Incontinence
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Treatment Success Based on Global Response Assessment Score
研究概览
简要总结
his prospective interventional study will evaluate the effectiveness and safety of peri-urethral injections of platelet-rich plasma for treating stress urinary incontinence in postmenopausal women. Platelet-rich plasma is prepared from each participant's own blood and contains concentrated platelets and growth factors that may promote tissue repair and regeneration.
Approximately 70 postmenopausal women with stress urinary incontinence will receive peri-urethral platelet-rich plasma injections once monthly for four consecutive months. Platelet-rich plasma will be injected into five sites around the urethra. Participants will be followed after treatment to assess improvement in urinary leakage and urinary symptoms, changes in urodynamic measurements, and treatment-related adverse events.
The study aims to determine whether repeated peri-urethral platelet-rich plasma injections can provide a safe and effective minimally invasive treatment option for postmenopausal women with stress urinary incontinence.
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women aged 45 years or older.
- •Stress urinary incontinence confirmed by urodynamic study with intrinsic sphincter deficiency.
- •Persistent stress urinary incontinence requiring pad use despite conservative management.
- •Patients unfit for surgical intervention and anesthesia.
- •Coagulation disorders or current anticoagulant therapy that cannot be safely discontinued.
- •Patients with comorbidities.
排除标准
- •Urinary tract infection.
- •Neurological disorders affecting lower urinary tract function.
- •Pelvic organ prolapse greater than stage II according to the Pelvic Organ Prolapse Quantification system.
- •Previous urethral surgery.
- •Inability or unwillingness to comply with follow-up visits.
研究组 & 干预措施
Peri-Urethral Platelet-Rich Plasma Injection
Participants will receive autologous platelet-rich plasma injections under local anesthesia. A total of 5 milliliters of platelet-rich plasma will be administered, with 1 milliliter injected at each of five peri-urethral submucosal sites corresponding to the 12, 2, 5, 7, and 10 o'clock positions. The injection procedure will be repeated once monthly for four consecutive months. Routine urinary catheterization will not be required after the procedure.
干预措施: Autologous Platelet-Rich Plasma (Biological)
结局指标
主要结局
Treatment Success Based on Global Response Assessment Score
时间窗: 1 month after the fourth platelet-rich plasma injection
Treatment response will be assessed using the Global Response Assessment score, which ranges from -3 to +3. A score of -3 indicates markedly worse symptoms, -2 indicates moderately worse symptoms, -1 indicates mildly worse symptoms, 0 indicates no change, +1 indicates mild improvement, +2 indicates moderate improvement, and +3 indicates marked improvement. Treatment success will be defined as a Global Response Assessment score of +2 or +3. The result will be reported as the number and percentage of participants achieving treatment success.
次要结局
- Dry Rate(1, 3, and 6 months after the fourth platelet-rich plasma injection)
- Change in Stress Urinary Incontinence Severity Assessed by the Visual Analogue Scale(Baseline through 6 months after the fourth platelet-rich plasma injection)
- Change in Abdominal Leak Point Pressure(Baseline and 3 months after the fourth platelet-rich plasma injection)
- Change in Maximum Urinary Flow Rate(Baseline and 3 months after the fourth platelet-rich plasma injection)
- Change in Voided Urine Volume(Baseline and 3 months after the fourth platelet-rich plasma injection)
- Change in Post-Void Residual Urine Volume(Baseline and 3 months after the fourth platelet-rich plasma injection)
- Change in Cystometric Bladder Capacity(Baseline and 3 months after the fourth platelet-rich plasma injection)
- Change in Voiding Detrusor Pressure at Maximum Urinary Flow Rate(Baseline and 3 months after the fourth platelet-rich plasma injection)
- Incidence of Treatment-Related Adverse Events(Through 6 months after the fourth platelet-rich plasma injection)
研究者
Mina Raafat Attia Banoub
Resident of Urology
Benha University