Holmium: YAG Versus Cold Knife Internal Urethrotomy in Management of Short Urethral Strictures: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Maximum flow rate (ml/sec.)
研究概览
简要总结
Urethral stricture disease is defined as narrowing of the urethral lumen because of fibrosis, which occurs in urethral mucosa and surrounding tissues. The etiology could be congenital, iatrogenic, infectious, or idiopathic.
Several techniques are currently available for minimally invasive treatment of urethral strictures, including cold-knife incision, electrocautery, and various types of laser incisions. An incision with the cold knife does not cause any thermal effect on surrounding tissues but should create a mechanical injury that may lead to recurrence in long term. An incision with the electrocautery should cause a significant thermal effect on healthy surrounding tissues resulting in recurrent strictures during follow-up. Laser treatment modalities have gained popularity in the last two decades.
the aim of this trial is to evaluate the safety and efficacy of endo-urethrotomy with Holmium laser and cold knife endo-urethrotomy
详细描述
Urethral stricture disease (USD) is the narrowing of the urethra from scar tissue, related to genitourinary tract infections, inflammatory skin conditions, traumatic urethral injury, pelvic radiation, and urinary tract instrumentation. It has an estimated prevalence rate of 0.6%.1-3 USD is a common and challenging problem for urologists. Multiple treatment modalities are available for the management of urethral strictures depending on the site and length of stricture, this includes simple urethral dilatation, urethral stenting, endoscopic visual internal urethrotomy (VIU), or open reconstruction.
Since 1974, Sachse's internal urethrotomy has been considered the treatment of choice for USD which is fast and simple to carry out and is associated with a short recovery time. The success rates are 33%-60%.
Bulow et al in 1979 introduced the laser for internal urethrotomy. The obvious dominance of Ho: YAG are clear vision, less bleeding, precise incision and ablation of scar tissue, and short hospital admission, however, most literature assessing the adequacy of the laser in contrast to cold-knife urethrotomy show no difference in final results.
The aim of this trial is to assess the efficacy, safety, complications, and results of Holmium laser urethrotomy and cold knife internal urethrotomy for urethral stricture.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
patients, data collector, and the statistician were blinded to the type of intervention. the assessment was done to group A and B
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •men with urethral stricture above the age of eighteen were included in our trial. the length of the urethral stricture was less than 1.5 cm.
排除标准
- •patient with complete urethral stricture with a suprapubic catheter in place.
- •patients whom internal urethrotomy is not applicable like multiple urethral strictures or balanitis xerotica obliterans.
研究组 & 干预措施
internal urethrotomy using Holmium laser representing group
In group 1, a three hundred micron laser fiber was used to conduct the laser energy. holmium laser pulse energy of approximately 1 joule was used that was generated from a Holmium laser Quanta device and total power of 15 watts. the laser fiber was aimed directly to the midline at 12 o'clock position to start the procedure and cut the fibrous tissue till access to a wide lumen.
干预措施: visualized internal urethrotomy (Procedure)
internal urethrotomy with Sachs cold knife
In group B, Sache cold knife internal urethrotomy was used with the same technique as Holmium laser internal urethrotomy at the same site to mechanically cut instead of the laser fiber.
干预措施: visualized internal urethrotomy (Procedure)
结局指标
主要结局
Maximum flow rate (ml/sec.)
时间窗: at 3 months
maximum flow rate, uroflow finding (ml/sec.)
Maximum flow rate(ml/sec.)
时间窗: at 12 months
maximum flow rate, uroflow finding (ml/sec.)
次要结局
- number of patients with penile extravasation(first day postoperative)
- number of patients with urethral stricture recurrence(from catheter removal up to 1 year postoperative)
- operation time in minutes(intraoperative finding)
- number of patients with bleeding per urethra(first day postoperative)
- number of patients with urinary tract infection(first month postoperative)
研究者
Ahmed Maher Gamil Ahmed Higazy
principle investigator
Ain Shams University