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临床试验/NCT03098147
NCT03098147Unknown不适用

The Influence of Benign Prostatic Hyperplasia on Bladder Function: A Multi-centre, Prospective and Case-control Study

Xiangfu Zhou1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2017年3月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
500
试验地点
1
主要终点
IPSS

研究概览

简要总结

Lower urinary tract symptoms(LUTS) are the main symptoms of benign prostatic hyperplasia(BPH), a benign but progressive disease which can advance to be with overactive bladder(OAB) symptoms. Moreover, LUTS and OAB symptoms can badly influence patients' especially the elderly's quality of life. Therefore, it appears to be urge to carry out researches on the functional impairment of bladder along with the advance of BPH. Besides, the management aimed at improving the LUTS and OAB symptoms come to be the key one among the management of BPH. For a long period, medication and surgery sustain to be the two most common therapies for BPH patients. Both patients and urologists prefer pharmacotherapeutics to surgery,which contributes to the rising number of BPH patients companied with OAB symptoms and storing symptoms complaint post-surgery. In fact, investigators usually find bladder impairment macroscopically in the BPH surgery: mild may be the trabeculation, worse can be the cabin, and severe may be the diverticula. Furthermore, it's not uncommon that patients with a long BPH history continually suffer from dysuria after surgery due to the detrusor muscle weakness. Consequently, investigators need to catch a moment when investigators should operate on such a patient in order to harvest a satisfying outcome. And perhaps the moment should be ahead of the existing guideline suggests. Thus, for understanding the influence of BPH on bladder function, investigators plan to conduct a prospective, case-control study recruiting in-patients with different degree of obstruction. Our team wish that such a clinical trail could provide valuable evidence for us to find out relatively better operating timing and serial indications. For the purpose of improving the quality of life and prolong life-span, investigators design the study above to maximum the operating outcome and minimize the bladder dysfunction.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

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
否

入选标准

  • •Sign the informed consent.
  • •The BPH in-patients who take 'dysuria' as the main self-reported symptom and meet the following conditions, 1) Maximal urinary flow rate less than 20 ml per second, 2) Volume of prostate more than 20ml measured by transrectal ultrasound 3) PSA ranges from 0 to 10ng/ml 4) IPSS>1

排除标准

  • •The lower urinary tract obstruction caused not by BPH
  • •Had a history of prostate cancer, surgery for benign prostatic hyperplasia or neurogenic bladder.
  • •using medications known to affect urination or had a severe concomitant disease

结局指标

主要结局

IPSS

时间窗: 1 year

International Prostate Symptom Score

次要结局

  • RUV(1 year)
  • Qmax(1 year)
  • OABSS(1 year)

研究者

发起方
Xiangfu Zhou
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Xiangfu Zhou

Professor

Third Affiliated Hospital, Sun Yat-Sen University

研究点 (1)

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