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临床试验/NCT05784909
NCT05784909尚未招募不适用

Outcomes of Water Vapor Thermal Therapy (REZUM) in Management of Symptomatic Patients With Benign Prostatic Enlargement

Assiut University0 个研究点目标入组 50 人开始时间: 2023年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
主要终点
duration of the operation

研究概览

简要总结

new treatment modality for BPH , less invasive and more effective.

详细描述

Benign prostatic hyperplasia (BPH) is a common urological condition characterized by progressive increase in the size of the prostate gland. It is a disease of ageing, affecting 40% of men in their 50s and 90% of men over 90 years causing bladder outflow obstruction (BOO), which results in lower urinary tract symptoms (LUTS) which have a significant impact on quality of life (QoL).

The current management for LUTS caused by BOO secondary to BPH includes conservative approaches (watchful waiting and lifestyle modifications), pharmacotherapy and surgical intervention.

The Surgical interventions include open surgery (suprapubic and perineal approaches),transurethral resection of the prostate (TURP) which was a revolutionary step in the management of BPH, and was considered the first minimally invasive treatment for prostate enlargement and With the improvement of endoscopes, development and incorporation of new technologies into the medical field, minimally invasive procedures have been more and more introduced as surgical options to treat BPH .

Minimally invasive procedures include water vapor thermal therapy (REZUM), trans urethral needle ablation, trans urethral microwave thermotherapy, prostate urethral lift and prostate artery embolization.

REZUM (water vapor thermal therapy) is considered one of the advanced minimal invasive procedure that uses the principles of convective heat transfer that exploits the thermodynamic properties of water to remove the excess prostate tissue that is pressing on the urethra.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • any patient diagnosed with BPH

排除标准

  • PATIENT REFUSING TO PARTICIPITATE

结局指标

主要结局

duration of the operation

时间窗: intra-operative

minutes or hours needed for the procedure

evaluation of the IPSS

时间窗: 1 month after treatment

to assess the success of treatment ,pre-operative and postoperative questionnaire will be done

次要结局

未报告次要终点

研究者

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

Mohamed Ahmed Zamra

specialist of urology

Assiut University

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