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临床试验/NCT06123520
NCT06123520已完成3 期

Efficacy of Holmium Laser Urethrotomy Versus in Combination With Intralesional Paclitaxel Injection in the Treatment of Urethral Stricture

Ain Shams University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年5月1日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
60
试验地点
1
主要终点
International prostate symptom score (IPSS) score

研究概览

简要总结

To evaluate the outcome of visual internal urethrotomy in treating urethral strictures in males with a holmium: yttrium-aluminium garnet (YAG) laser versus when combined with intralesional injection of paclitaxel.

详细描述

Urethral strictures are one of the most common reasons for urological admissions. They are associated with urinary tract infections, bladder stones, fistulas, sepsis and possibly renal insufficiency. Minimally invasive surgical approaches are utilized efficiently and safely in the treatment of urethral strictures. Visualized internal urethrotomy VIU, is one of the preferred methods due to the practical and minimally invasive nature of the procedure. One of the alternative approaches is the correction of the stricture using laser energy. The aim of this prospective study is to evaluate the results of YAG laser internal urethrotomy (HIU) in primary urethral strictures versus using laser with intralesional submucosal paclitaxel injection.

It is a prospective study in which patients will be recruited from the outpatient clinic of Demerdash (ain Shams university) hospital, randomized via closed envelope technique into doing VIU alone versus doing VIU with intralesional injection of paclitaxel

After obtaining well informed written consent, all patients will undergo the following

  1. Detailed history taking, including medical history, surgical history, and patient complaint according to international prostate symptom score (IPSS) score. A note will be made about the possible etiology of the stricture.
  2. Clinical Examination including abdominal, pelvic and genital examination.
  3. Laboratory investigations including complete blood count, urine analysis, urine culture and sensitivity test, renal function tests.
  4. Radiological investigations including retrograde urethrogram, micturating cystourethrogram and pelvi-abdominal ultrasound.
  5. Uroflowmetry

Any active urinary tract infection (UTI) will be treated before surgery with appropriate antibiotics based upon sensitivity test.

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
18 Years 至 60 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

International prostate symptom score (IPSS) score

时间窗: at 3, 6 months

Clinical effectiveness in improving patient reported lower urinary tract symptoms according to IPSS with a score from 0 to 35 by answering 7 questions, each question with a 0 till 5 points with total score from 0 till 35. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.

uroflowmetry

时间窗: at 3, 6 months

the quantitative assessment of the flow of urine using uroflowmetry with a score higher than 15 ml/sec indicating no obstruction while from 0-10 indicates obstructed flow and between 10 to 15 obstruction is suspected requiring further investigations.

次要结局

  • assessment of postoperative infection.(Patient will be discharged from hospital being 24 hours fever free postoperative.)
  • assessment of intraoperative bleeding(immediatly postoperative)
  • assessment of operative time.(immediately intraoperative.)
  • assessment of recurrence rate.(at 3 and 6 months postoperative)

研究者

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

Younan Ramsis

Lecturer

Ain Shams University

研究点 (1)

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