Veil-preserving Versus Standard Holmium Laser Enucleation of the Prostate: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- urine incontinence
研究概览
简要总结
Postoperative transient stress urine leakage following Holmium laser enucleation of the prostate is one of the problems that frustrate both surgeon and patients
Standard HoLEP might be associated with some stretch of the sphincter and de-epithelization of the sphincter area anteriorly.
In Veil preserving HoLEP, early separation of the adenoma from the sphincter ring minimizes sphincter stretch. Furthermore, more proximal incision of the 12 O'clock mucosal strip sparring a veil of mucosa covering the sphincter ring.
Our hypothesis is that by this technique the early postoperative transient urine leak would be minimized and duration of leakage if anny would be shortened.
详细描述
Postoperative transient stress urine leakage following Holmium laser enucleation of the prostate is one of the problems that frustrate both surgeon and patients.
Many reports addressed different variables for the cause of post HoLEP urine leakage. Looking for a procedure done by a single surgeon who had tremendous experience of this procedure may enable investigators to identify precisely technical points of interest that may affect post HoLEP stress urine incontinence.
Standard HoLEP might be associated with some stretch of the sphincter and de-epithelization of the sphincter area anteriorly.
In Veil preserving HoLEP, early separation of the adenoma from the sphincter ring minimizes sphincter stretch. Furthermore, more proximal incision of the 12 O'clock mucosal strip sparring a veil of mucosa covering the sphincter ring.
Investigators' hypothesis is that by this technique the early postoperative transient urine leak would be minimized and duration of leakage if any would be shortened.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients' age ≥50 years
- •ASA (American society of anesthesiologists) score ≤
- •TRUS estimated weight ≥40 grams.
- •Exclusion criteria:
- •Patients who have any of the following were excluded:
- •Patient with neurological disorder which might affect bladder function as cerebrovascular stroke or Parkinson disease.
- •Active urinary tract infection.
- •Presence of bladder cancer (within the last 2 years).
- •Prostate cancer patients.
- •Patients with bleeding tendency, ongoing anticoagulants or antiplatelet medications
- •Previous prostate surgery
排除标准
- 未提供
结局指标
主要结局
urine incontinence
时间窗: 1 month postoperative
one hour pad test for post prostatectomy incontinence, scale from 0 to 4, the higher the more incontinence
次要结局
- urine flow rate(1 year)
- International Consultation on Incontinence Questionnaire Short-Form(one month postoperative)
- international prostate symptom score(1 year)
- urine incontinence(4 months postoperative)
研究者
Ahmed Elshal
Principal Investigator
Mansoura University