Safety and Efficacy of Combination of Tamsulosin 0.4 mg Plus Tadalafil 5mg Versus 2.5 mg for Ureteric Stent Related Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Evaluation of Ureteral Stent Symptoms
研究概览
简要总结
Ureteral stenting is a common urological procedure performed to relieve obstruction and facilitate urinary drainage. Despite its effectiveness, stent-related symptoms (SRS) such as dysuria, frequency, urgency, flank pain, and sexual discomfort negatively affect patient quality of life.
Pharmacological management with alpha-blockers such as Tamsulosin and phosphodiesterase-5 inhibitors (PDE5i) such as Tadalafil has shown promise in reducing SRS. While low-dose Tadalafil (2.5 mg) has not been explored, its comparative effectiveness against the standard 5 mg dose when combined with Tamsulosin remains under-researched. This study aims to evaluate the difference in reduction of SRS between Tamsulosin with Tadalafil in standard and half dosage.
详细描述
Ureteral stents are commonly used for temporary drainage in various urological procedures. Despite their usefulness, they are frequently associated with bothersome symptoms collectively termed as "stent-related symptoms" (SRS),These symptoms include flank pain, lower urinary tract symptoms (LUTS), hematuria, dysuria, urgency, frequency, and sexual dysfunction.
The exact pathophysiology of SRS is multifactorial, involving local irritation, vesicoureteral reflux, and smooth muscle spasm.
Various pharmacological agents have been studied to alleviate these symptoms, with alpha-blockers and PDE-5 inhibitors showing promising results .
Tamsulosin, a selective al-blocker, reduces bladder neck and distal ureteral smooth muscle tone, alleviating irritative urinary symptoms.
Tadalafil, a PDE-5 inhibitor, has been shown to improve LUTS through its smooth muscle relaxation and increased perfusion effects. While both have been studied individually and in combination, the optimal dose of Tadalafil in combination therapy is yet to be clearly established
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
- None
入排标准
- 年龄范围
- 18 Years 至 71 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- patients older than 18 years of age, with presence of a double-J (DJ) stent (polyurethane) post endoscopic stone removal.
排除标准
- •Patients younger than 18 years of age were excluded.
- •Patients with a history of prostate or bladder surgery were excluded.
- •Patients with prior lower urinary tract procedures were excluded.
- •Patients with cancer were excluded.
- •Patients with neurological conditions were excluded.
- •Patients with a history of pelvic radiation were excluded.
- •Patients with diabetes were excluded.
- •Patients with kidney dysfunction (acute or chronic) were excluded.
- •Patients with a solitary kidney were excluded.
- •Patients with congenital urinary anomalies were excluded.
- •Patients taking the following medications were excluded:
- •α-blockers
- •beta-blockers
- •calcium channel blockers
- •5-alpha reductase inhibitors
- •PDE5 inhibitors
- •anticholinergics
- •Patients with cardiac issues were excluded.
- •Patients with residual stone fragments after surgery were excluded.
- •Patients with multiple or bilateral ureteral stones were excluded.
- •Patients with long-term or bilateral stents requiring frequent changes were excluded.
- •Patients with interstitial cystitis were excluded.
- •Patients with chronic cystitis were excluded.
- •Patients with prostatitis were excluded.
- •Pregnant women were excluded.
- •Breastfeeding women were excluded.
- •Patients unavailable for follow-up were excluded.
研究组 & 干预措施
Group A : (Tamsulosin 0.4 mg + Tadalafil 2.5 mg)
About 70 patients will receive Tamsulosin 0.4 mg + Tadalafil 2.5 mg tablets daily for evaluation of relieving stent-related symptoms
干预措施: Tamsulosin (Drug)
Group B:(Tamsulosin 0.4 mg + Tadalafil 5 mg)
About 70 patients will receive Tamsulosin 0.4 mg + Tadalafil 5 mg tablets daily for evaluation of relieving stent-related symptoms
干预措施: Tamsulosin (Drug)
结局指标
主要结局
Evaluation of Ureteral Stent Symptoms
时间窗: 4 weeks
Evaluation of Ureteral Stent Symptoms postoperatively using Questionnaire (USSQ) score after treatment (from 1 to 5) as: 1 is best relief of symptoms but 5 is worsen relief of symptoms
次要结局
未报告次要终点
研究者
Ahmed Amr
Resident at Urology Department
Ain Shams University