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临床试验/NCT05945420
NCT05945420招募中4 期

Outcome of Adding Desmopressin to Tamsulosin for Treatment of Nocturnal Polyurea in Patients With Benign Prostatic Obstruction

Mansoura University1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2023年7月20日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
招募中
入组人数
160
试验地点
1
主要终点
Change of symptoms and nocturia disappears or improve

研究概览

简要总结

In this study investigators will add desmopressin for treatment of patients with benign prostatic hyperplasia and nocturnal polyurea

详细描述

Investigators will give a group of patients tamsulosin and desmopressin and the other group will take tamsulosin and placepo and compare the outcome regarding symptoms of being prostatic hyperplasia especially nocturia and the effect on nocturnal polyurea in patients

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
50 Years 至 80 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Men with BPH Age more than 50years Patients with nocturia (2voids per night or More) Patients with nocturnal polyurea (urine volume More than 33%of urine allover the day) IPSS more than 12 Obstructed flow curve Post voiding residual less than 150

排除标准

  • men with BPH with : Acute urine retention Neurogenic bladder dysfunction Cardiovascular disease Hyponatremia Urethral stricture Bladder calculi Prostate cancer

研究组 & 干预措施

Desmopressin arm

Active Comparator

This arm will receive tamsulosin and desmopressin

干预措施: Desmopressin Acetate (Drug)

Placebo arm

Placebo Comparator

This arm will receive tamsulosin and placepo

干预措施: Placebo (Drug)

结局指标

主要结局

Change of symptoms and nocturia disappears or improve

时间窗: Follow up for 6 months

Investigators will compare symptoms in the pretreatment period and follow up symptoms following treatment and record the outcome

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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