A Randomized Controlled Trial to Examine the Utility of Tadalafil (5mg) For Treatment of Early Storage Symptoms and Erectile Dysfunction After Anatomical Endoscopic Enucleation of Prostate (AEEP)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Orgasm perception domain of International Index of Erectile Function (IIEF-15) questionnaire at 6 months among the study groups
研究概览
简要总结
From previous studies, the investigators found that sexual outcomes after prostate surgery may show insignificant improvement, remain unchanged or deteriorate in non-negligible number of patients especially those with high preoperative IIEF scores. Deterioration of erectile function could be attributed to persistence of storage symptoms specially nocturia. Several pathophysiologic mechanisms, described before, are involved in pathogenesis of LUTS and ED and one can imagine that after relief of obstruction, the erectile function should improve, however lack of improvement or even deterioration suggests that damage associated with these mechanisms is irreversible and patients may require some sort of penile rehabilitation after surgery.
The investigators hypothesized that Tadalafil may enhance relief of storage symptoms and enhance recovery of erectile function after surgery for BPH. With this assumption, a RCT was designed to examine the utility and efficacy of Tadalafil, once daily dose, to relieve persistent/ de novo storage symptoms and early erectile function deterioration after endoscopic prostate surgery.
详细描述
I. Introduction
Benign prostatic hyperplasia (BPH) accompanied by bothersome lower urinary tract symptoms (LUTS) is a common and progressive condition that significantly affects quality of life (QOL) in men. LUTS include storage, voiding, and post-micturition symptoms. Storage symptoms are referred as particularly bothersome and cause significant morbidity . Several population based studies demonstrated a strong association between LUTS and erectile dysfunction (ED) among BPH patients. This is believed to be independent of age and associated comorbidities like cardiovascular disease and diabetes mellitus.
Several mechanisms have been postulated to explain the relationship between LUTS and ED. First, impairment of nitric oxide (NO) production specially with conditions like hypertension and metabolic syndrome . Second, enhanced Rho/ROCK pathway that leads to impaired smooth muscle relaxation resulting in ED and LUTS. Overexpression of Rho/ROCK pathway has been found in hypertensive rats . Third, sympathetic over- activity, in particular, overexpression of α1A and α1D adrenergic receptors that are present mainly in prostate and hypertrophied detrusor muscle, respectively. Experimental studies demonstrated that hypertensive rats had increased sympathetic innervation to bladder and prostate, LUTS and ED. Furthermore, improvement of ED occurred after control of hypertension. Lastly, pelvic ischemia that results from atherosclerosis plays an important role in development of LUTS and ED via induction of fibrosis and decreased NO levels. In a cross sectional study by Berger et al , the authors found that patients with BPH and ED had lower perfusion and higher resistive index of the transition zone of prostate compared to young adults.
The main objective for treatment of BPH is to relieve LUTS and consequently improving quality of life. Anatomical endoscopic enucleation of prostate (AEEP) including, HoLEP and ThuLEP is recommended by the European Urological Association guideline as an efficient and advanced minimally invasive, size-independent surgical therapy of BPO. Their long-term efficacy, durability and safety have been proven in several prospective and randomized controlled studies .
I.1 Problems frequently encountered after AEEP that affect quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients' age ≥ 40 years
- •LUTS secondary to BOO due to BPH who failed medical treatment
- •International prostate symptom scores (IPSS) >15 and bother score (QOL) ≥ 3 (according to IPSS question 8)
- •Peak urinary flow rate (Qmax) <15 ml/sec.
- •ASA (American society of anaesthesiologists) score ≤
- •Sexually active men, not receiving PDE5I
排除标准
- •Patients using nitrates, potassium channel opener, or α1-blockers doxazosin and terazosin for control of hypertension
- •Patients with unstable angina pectoris, recent myocardial infarction or stroke myocardial insufficiency.
- •Patients with severe hepatic or renal insufficiency.
- •Patients who are sexually inactive.
- •Patients with uncontrolled diabetes mellitus or neurologic condition(eg. parkinsoism)
研究组 & 干预措施
Tadalafil 5 mg daily
those patients will receive Tadalafil 5 mg daily after HoLEP
干预措施: Tadalafil 5mg / Placebo (Drug)
Placebo
Those patients will receive Placebo after HoLEP
干预措施: Tadalafil 5mg / Placebo (Drug)
结局指标
主要结局
Orgasm perception domain of International Index of Erectile Function (IIEF-15) questionnaire at 6 months among the study groups
时间窗: 1 and 3 months postoperatively (during treatment), and at 6 months postoperatively (3 months after treatment cessation)
the erectile function will be assessed using a validated questionnaire and compared to baseline .
次要结局
- Change in International Prostate Symptom Score (IPSS) with its subdomains voiding and storage once at different follow up points.(2 weeks, 1, 3 months (during treatment) and at 6 months postoperatively ( 3 months after treatment cessation))
研究者
Mahmoud Laymon
Principal investigator
Mansoura University