Impact of Daily Tadalafil 5 mg on Storage Lower Urinary Tract Symptoms After Anatomical Endoscopic Enucleation of the Prostate :A Randomized , Single Blinded ,Controlled Trial"
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Proportion of patients achieving stress urine incontinence at 12 weeks post op, assessed by IPSS score
研究概览
简要总结
The aim of this study is to evaluate the impact of daily tadalafil 5 mg on storage lower urinary tract symptoms (LUTS) during the early postoperative period following Anatomical endoscopic enucleation of prostate in a randomized controlled clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
The drug
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Must be able to swallow tablets
- •Adult males undergoing elective AEEP for symptomatic benign prostatic hyperplasia (BPH) with prostate volume ≥40 ml , Moderate to severe LUTS defined by International Prostate Symptom Score (IPSS) ≥19 at baseline.
- •Patient is Willing to participate and able to provide written informed consent
排除标准
- •Contraindications to tadalafil (e.g., nitrate use, severe hepatic/renal impairment, uncontrolled hypotension) , neurogenic bladder. , Preoperative urinary catheter dependence , post-void residual urine >350 ml. ,, Cognitive impairment precluding questionnaire completion
研究组 & 干预措施
Daily tadalafil 5 mg user
Patients will have daily tadalafil 5 mg for 3 months post AEEP
干预措施: Tadalafil 5mg (Male) (Drug)
Placebo
Omiga 3 for patient
干预措施: Omiga 3 (Drug)
结局指标
主要结局
Proportion of patients achieving stress urine incontinence at 12 weeks post op, assessed by IPSS score
时间窗: 12 weeks
More Precise Academic Wording: * Proportion of patients: The percentage (%) of the total study population. * Stress urinary incontinence (SUI): Involuntary leakage of urine during activities that increase intra-abdominal pressure (e.g., coughing, sneezing, lifting). * 12 weeks post-operative: Three months after surgery. * Assessed by IPSS score: Evaluation based on patient responses to the International Prostate Symptom Score questionnaire. Important Methodological Note: The International Prostate Symptom Score (IPSS) is primarily designed to assess lower urinary tract symptoms (LUTS) such as: * Frequency * Urgency * Weak stream * Nocturia
次要结局
- Change from baseline in IPSS storage subdomain score at 4 weeks , 8weeks , and 12 weeks. Time to micturate freely IPSS total .(12 weeks)
研究者
Ali Adel Mansour Hageb
Dr
Assiut University