JPRN-jRCTs031230450招募中Unknown
Efficacy and safety of vibegron add-on therapy on persistent overactive bladder symptoms in benign prostatic hyperplasia patients with alpha blocker treatment - VATON study
Yoshida Masaki0 个研究点目标入组 160 人开始时间: 2023年11月17日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 160
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 50age old 至 ot applicable（—）
- 性别
- Male
入选标准
- •At the time of consent:
- •- Men patients 50 years of age or older at the date of consent
- •- Patients with BPH diagnosed by basic evaluation and other diagnostic methods
- •- Patients who agree to comply with the study settings for prohibited concomitant drugs/therapies and restricted concomitant drugs
- •- Patients who have been using the identical basic alpha-1 blocker (silodosin, tamsulosin or naftopidil) at the same dosage for at least 8 weeks prior to Visit 1
- •- Patients who gave written consent
- •Visit 1 (week 0):
- •- Patients who have been using the identical basic alpha-1 blocker (silodosin, tamsulosin, or naftopidil) at the same dosage for at least 8 weeks prior to Visit 1
- •- Prostate volume greater than or equal to 20 mL (either by transabdominal or transrectal ultrasonography within 6 months is eligible)
- •- Patients with an OABSS Q3 score of at least 2 points and an OABSS total score of at least 3 points
- •- Patients who have adequately completed a bladder diary
排除标准
- •At the time of consent:
- •- Patients with neurogenic bladder (physician's discretion)
- •- Patients with a history of surgery for BPH
- •- Patients with urinary retention
- •- Patients with stress urinary incontinence only
- •- Patients with orthostatic hypotension
- •- Patients with prolonged catheterization or self-catheterization
- •- Patients with complications that present with symptoms similar to OAB (diabetes insipidus, urinary stone, urinary tract infection, interstitial cystitis, prostatitis) that, at the discretion of the principal investigator or subinvestigators, may affect the evaluation of this study
- •- Patients with a history of injury, surgery, or neurodegenerative disease (e.g., multiple sclerosis) affecting the lower urinary tract and innervation
- •- Patients with bladder or prostate cancer who are undergoing or will undergo treatment
- •- Patients with prior hypersensitivity to vibegron
- •- Patients with serious cardiac disease or severe hepatic dysfunction
- •- Patients who are judged unsuitable for inclusion in this trial by the principal investigator or subinvestigators.(e.g., patients diagnosed with dementia)
- •Visit1 (0 week):
- •- Patients with post-void residual urine volume greater than or equal to 100 mL
- •- Patients with a maximum urine flow rate (Qmax) of less than 5 mL/s (when a single voided volume of 100 mL or more is measured)
- •- Patients with polyuria (daily urine volume averaging more than 3000 mL per day)
- •- Patients who are unable to comply with study settings for prohibited concomitant drugs or therapies during the specified period
- •- Patients who started taking or changed the dosage of restricted concomitant drugs during the specified period
研究者
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