The Efficacy of a Suppository Based on Phenolmicin P3 and Bosexil in Control of Irritative Symptoms in Patients Undergoing Thulium Laser Enucleation of Prostate: a Single-center, Randomized, Controlled, Open Label, Phase III Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- IPSS
研究概览
简要总结
In this single-center, prospective, randomized, open label, phase-III study, patients with indication to Thulium Laser Enucleation of Prostate were enrolled. The report conformed to CONSORT 2010 guidelines. Eligible patients were 1:1 randomized. Randomization defined Group A: patients who were administered Phenolmicin P3 and Bosexil suppositories twice a day for 5 days, then once a day for other 10 days; Group B: patients who did not receive the suppositories ("controls"). Study endpoints were evaluated at 15 and 30 days postoperation. Primary endpoint included evaluation of effects of the suppository on irritative symptoms by administering International Prostate Symptom Score (IPSS) with Quality of Life (QoL) questionnaire. Secondary endpoint included evaluation of effects on urinary tract infections by performance of urinalysis with urine culture.
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 99 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •- Patients with symptomatic benign prostatic hyperplasia deemed eligible for thulium laser enucleation of prostate.
排除标准
- •patients with history of prostatitis,
- •patients with history of neurogenic detrusor overactivity (as determined after urodynamic observation),
- •patients diagnosed with prostate cancer,
- •patients who underwent previous surgeries of the lower urinary tract,
- •patients with indwelling catheter,
- •patients with history of nephrolithiasis,
- •patients with known or suspected hypersensitivity to Phenolmicin P3 and/or Bosexil
- •patients experiencing occurrence of severe intraoperative complications.
结局指标
主要结局
IPSS
时间窗: 15 and 30 days post-operation
evaluation of effects of the suppository on irritative symptoms as assessed by eventual reduction in International Prostate Symptom Score (IPSS). Specifically, % reduction in absolute value of IPSS will be compared between the groups.
QoL
时间窗: 15 and 30 days post-operation
evaluation of effects of the suppository on Quality of life as assessed by eventual reduction in Quality of Life score. Specifically, % reduction in absolute value of QoL will be compared between the groups.
次要结局
- Urinary Infection(15 and 30 days post-operation)