Prospective Observational Trial of Combination Therapy of Tadalafil 5mg Plus Tamsulosinmg for Men With Lower Urinary Tract Symptoms and Erectile Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 主要终点
- Lower Urinary Tract Symptoms
研究概览
简要总结
Metabolic Syndrome (MetS) is a complex epidemic disorder with an impact on both lower urinary tract symptoms (LUTS) and erectile dysfunction (ED). Combination therapy of daily tadalafil and tamsulosin may provide relief to both diseases.
Aim of the present study is to assess the impact of combination therapy of Tadalafil 5mg plus Tamsulosin 0.4mg on LUTS and ED, according to presence vs. absence of Mets.
详细描述
75 Consecutive men presenting with ED and LUTS suggestive of bladder prostatic obstruction were enrolled. Patients were divided into two groups according to MetS presence or absence. All subjects were then treated with tadalafil 5 mg/die plus tamsulosin 0.4 mg/die for 12 weeks. Patients were re-evaluated after 12 weeks of treatment with Uroflowmetry and PVR, IPSS, IPSS QoL, OAB-q and IIEF-5 and comparison were made in and between groups.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •mild to severe ED (International Index of Erectile Function-Erectile Function-5 <22)
- •moderate to severe LUTS (International Prostate Symptom Score >7)
排除标准
- •hypersensitivity to tadalafil or tamsulosin
- •prostatic cancer or suspected with prostate-specific antigen (PSA) >4 ng/mL
- •bladder lithiasis
- •previous prostatic surgery
- •urinary tract infection
- •neurogenic bladder
- •finasteride or dutasteride use within 3 or 6 months respectively
- •clinical history of urethral and/or proven bladder neck obstruction
研究组 & 干预措施
Combination Therapy
Patients initial assessment included age, waist circumference, blood pressure, clinical laboratory parameters, digital rectal examination. LUTS were evaluated with total IPSS, focusing also on storage, voiding IPSS sub-scores, and IPSS QoL, and Overactive Bladder questionnaire (OAB-q), while ED with IIEF-515. Each patient underwent uroflowmetry and postvoid residual volume (PVR) was measured with abdominal ultrasound immediately after voiding. All patients reporting any intake of therapies for LUTS or ED underwent a 4 weeks treatment-free washout period.
All subjects were treated with tadalafil 5 mg/die plus tamsulosin 0.4 mg/die for 12 weeks. The medications were self-administered every day at the same time, before the night rest, without any limitations or variations of sexual activity timing or food intake. Patients were re-evaluated after 12 weeks of treatment with Uroflowmetry and PVR, IPSS, IPSS QoL, OAB-q and IIEF-5
干预措施: Tadalafil 5mg (Drug)
结局指标
主要结局
Lower Urinary Tract Symptoms
时间窗: Changes from Baseline IPSS at 3 months
Through IPSS
Lower Urinary Tract Symptoms - Storage
时间窗: Changes from Baseline OAB-q at 3 months
Through OAB-q
Erectile Dysfunction
时间窗: Changes from Baseline IIEF-5 at 3 months
Through IIEF-5
Flowmetry Maximum Flow
时间窗: Changes from Baseline Maximum Flow at 3 months
Through Maximum Flow (ml/s)
Flowmetry Post Void Residual
时间窗: Changes from Baseline Post Void Residual at 3 months
Through Post Void Residual (ml)
次要结局
- Combination Therapy Adverse Events(3 months)
- Combination Therapy Compliance(3 months)
- Combination Therapy Tolerability(3 months)
研究者
Simone Morselli
MD
University of Florence