Evaluation of Solifenacin in the Treatment of OAB Symptoms in Patients Who Have Successfully Undergone GreenLight Photoselective Vaporization of the Prostate (PVP)for the Treatment of Clinically Significant Benign Prostate Hyperplasia (BPH)
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Change in number of micturitions per 24 hours utilizing a 3 day micturition diary
研究概览
简要总结
The purpose of this study is to demonstrate that solifenacin post-operatively improves irritative symptoms in men whose obstructive symptoms have been relieved with the GreenLight laser outpatient procedure.
详细描述
Obstruction of the urinary tract secondary to benign prostatic hyperplasia can result in both obstructive and irritative urinary symptoms. In the last few years, photovaporization of the prostate has emerged as a popular teatment for this problem. This outpatient procedure uses a GeenLight KTP laser manufactured by Laserscope to vaporize the obstructing aspects of the prostatic urethral tissue to create a central cavity. After obstruction is relieved , it is not uncommon for a patient to be left with the irritative symptoms of frequency, urgency and nocturia, either from the procedure itself in the short-term or due to changes that develop in the bladder due to the long-standing obstruction. Clinical experience with this procedure indicates that after the mechanical obstruction of the prostate is relieved, medical therapy with an antimuscarinic agent should be able to alleviate these irritative urinary symptoms without the risk of urinary retention. By adding solifenacin in the early post operative period ( 2-12 weeks)for the subset of patients still experiencing irritative symptoms, further improvements in bladder symptoms my be achieved.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Written informed consent obtained
- •Male patients greater than 18 years of age with continued OAB symptoms after successful PVP for BPH.
- •Patients may be included if they have previously been treated with FDA approved anticholinergic agents for the treatment of OAB such as Oxybutynin chloride(generic oxybutynin chloride, Ditropan XL, or Oxytrol) Tolterodine tartrate(Detrol or Detrol LA), or trospium chloride(Santura) and are no longer receiving such treatment for a minimun of 14 days prior to study
排除标准
- •Previous treatment with darifenacin
- •Urinary obstruction as defined as a Qmax < 12 ml/sec at time of study entry.
- •Urinary retention as defined as PVR > 150 ml
- •Neurogenic Bladder
- •Prostate Cancer
- •Chronic inflammation( i.e. interstitial cystitis)
- •Bladder stones
- •History of bladder cancer
- •Urinary tract infection
- •Uncontrolled narrow-angle glaucoma
- •Gastric retention
- •History of diagnosed gastro-intestinal obstructive disease.
- •Severe renal or hepatic impairment
- •Concomitant anticholinergic or antispasmodic medications.
- •Known or suspected hypersensitivity to Solifenacin, any of its components (lactose monohydrate, corn starch, hydromellose 2910, magnesium stearate, talc, polyethylene glycol 8000 ant titanium dioxide with yellow ferric oxide(5 mg tablet) or red ferric oxide(10 mg tablet, or other anticholinergics.
- •Participation in any clinical trial involving an investigational drug, within 30 days prior to enrollment.
- •Any clinical condition, which in the opinion of the investigator, would not allow safe completion of the study.
结局指标
主要结局
Change in number of micturitions per 24 hours utilizing a 3 day micturition diary
时间窗: 12 weeks
次要结局
- Change in mean nocturia episodes/24 hours based on 3 day diary(12 weeks)