Comparison of Holmium Laser Versus Cold Knife Treatment in Patients With Urethral Strictures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Mean Peak urinary flow rate
研究概览
简要总结
The goal of this study is to assess the efficacy of optical internal urethrotomy, which uses a holmium laser in comparison to a cold knife, in treating short-segment urethral strictures in our local setting. The study will help standardize treatment protocols for urethral stricture based on functional results. The local findings will encourage adoption of minimally invasive laser techniques in public hospitals, improving access to modern urologic care. The study will help in informed decision making, enabling patients to understand treatment options and their expected outcomes based on evidence.
详细描述
Urethral stricture, one of the earliest known urologic conditions, is still prevalent and challenging to cure. It is a common illness with a high morbidity rate; its estimated frequency is around 0.6% in industrialized areas and may be higher in developing regions. The various therapeutic options are influenced by depth, location, and length of scarring of stricture. These include electrocautery, cold-knife urethrotomy, and other laser treatments.3 These have gained particular popularity in the last 20 years.
A cold-knife incision may cause mechanical injuries that could lead to recurrence while preventing thermal damage to the surrounding tissues. On the other hand, recurrence of strictures and severe heat injury are possible outcomes of electrocautery. The Holmium:YAG (Ho:YAG) laser has been the most widely used laser treatment in recent years due to its precision and efficacy. After carefully advancing the Sachse Urethrotome to the stricture site, the stricture is incised using the 12 o'clock position technique until it is sufficiently treated.6 A range of lasers, such as carbon dioxide, argon, yttrium aluminum-garnet (YAG), neodymium (Nd), and holmium (Ho):YAG, are also used to treat the urethral strictures. The Ho:YAG laser is gaining popularity as an endourology method due to its high precision and minimal heat impact on surrounding tissues.
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 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males aged 18 to 70 years with short segment urethral strictures (length <2 cm), planned to undergo internal urethrotomy
排除标准
- •Patients with multiple or recurrent strictures, those with active urinary tract infections, complete urethral obliteration on urethroscopy, with pan-anterior strictures, posterior stenosis, failed prior interventions, or lichen sclerotic changes
研究组 & 干预措施
Holmium laser
in holmium laser urethrotomy procedure, a laser fiber is passed through a cystoscope, and precise incisions are made in the stricture, usually at the 12 o'clock position, to widen the lumen
干预措施: holmium laser (Device)
cold knife
In cold-knife urethrotomy procedure, a cystoscope is passed into the urethra, and a cold knife is utilized for incising the stricture at 12 o'clock position to widen the narrowed lumen to restore normal urine flow
干预措施: cold knife (Device)
结局指标
主要结局
Mean Peak urinary flow rate
时间窗: 30 days
Urinary flow in ml/sec will be measured on uroflowmetry on enrollment and 30-days post-operatively
次要结局
未报告次要终点
研究者
Dr Mudassar Saeed Pansota
Associate Professor
Shahida Islam Medical Complex