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临床试验/NCT02279615
NCT02279615Unknown4 期

EFFICACY AND SAFETY OF COMBINATION THERAPY WITH β3-ADRENOCEPTOR AGONIST (MIRABEGRON) AND α-ADRENOCEPTOR ANTAGONIST (TAMSULOSIN) FOR TREATMENT OF OVERACTIVE BLADDER IN MALE PATIENTS WITH BENIGN PROSTATIC HYPERPLASIA.

St. Joseph's Healthcare Hamilton1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
200
试验地点
1
主要终点
International Prostate Symptom Score (IPSS)

研究概览

简要总结

The purpose of this study is to investigate the safety and efficacy of combination therapy involving β3-adrenoceptor agonist, mirabegron, and α-blockers for the treatment of OAB symptoms in male patients with BPH.

详细描述

Mirabegron (MyrbetriqTM, Astellas Pharma Inc.) is a drug that is approved by the FDA for the treatment of overactive bladder (OAB) with symptoms of urinary frequency, urgency and urgency incontinence. Multiple studies have shown that this drug also has the potential to improve patient tolerability, compliance and subsequent patient quality of life without inducing unfavourable adverse events commonly associated with antimuscarinic medications. These adverse events include, but are not limited to, dry mouth, constipation, confusion, and acute urinary retention (AUR).

Studies now have shown that mirabegron may also provide an effective treatment option for OAB in men with benign prostatic hyperplasia (BPH) without inducing the above mentioned adverse events. This study will look at the combination therapy of Mirabegron and Tamsulosin, versus Tamsulosin and placebo alone to prove that this treatment (Mirabegron and Tamsulosin) is effective for those men who suffer from both overactive bladder along with benign prostatic hyperplasia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
50 Years 至 90 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Male patients over the age of 50
  • Clinical BPH on stable dose of alpha-blocker therapy for more than 1 month
  • OAB symptoms (frequency, urgency, nocturia, urgency incontinence)

排除标准

  • Post-void residual (PVR) > 200mL
  • Active, culture-proven urinary tract infection
  • Acute/chronic prostatitis
  • Previous lower urinary tract malignancy (i.e. bladder, prostate malignancy)
  • History of cystolithiasis
  • Previous pelvic surgery (i.e. prostatectomy, cystectomy, recent pelvic/endourologic instrumentation including cystoscopy, nephroscopy, ureteral stent insertion, Transrectal Ultrasound (TRUS) biopsy)
  • Previous pelvic radiation

研究组 & 干预措施

Treatment Group

Active Comparator

(Mirabegron + Tamsulosin)

干预措施: Mirabegron (Drug)

Treatment Group

Active Comparator

(Mirabegron + Tamsulosin)

干预措施: Tamsulosin (Drug)

Control Group

Placebo Comparator

(Placebo + Tamsulosin)

干预措施: Tamsulosin (Drug)

结局指标

主要结局

International Prostate Symptom Score (IPSS)

时间窗: Treatment period: 4 weeks

Measured before and after combination therapy.

Quality of Life Score (QoLS)

时间窗: Treatment period: 4 weeks

Measured before and after combination therapy

Overactive Bladder Symptom Score (OABSS)

时间窗: Treatment period: 4 weeks

Measured before and after combination therapy

次要结局

  • Adverse Events(Timeline: 4 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anil Kapoor

MD, FRCSC

St. Joseph's Healthcare Hamilton

研究点 (1)

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