Management of Urethral Injury During Penile Prosthesis Implantation: Urethral Sterilization With Chlorhexidine Digluconate to Facilitate Primary Repair and Same-Session Implantation
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Bacterial colonization by culture and sensitivity
研究概览
简要总结
The introduction of penile implants has revolutionized the management of male erectile dysfunction. However, a number of intraoperative complications may occur, which have a major impact on clinical outcomes and patient satisfaction such as bleeding, infection and urethral injury.
Patients undergoing penile implant surgery with fibrotic corpora (e.g., after priapism, after infection, or with Peyronie disease) have a higher risk rates of urethral perforation. This may be related to previous scarring, the difficultly in dilating scarred and fibrotic corpora and its inherent risk of corporal crossover and urethral perforation.
This work examines the efficacy of pre-operative urethral sterilization in rendering the urethra as sterile as the skin of the genital area, with the skin sterilized as per the ISSM guidelines for penile prosthesis implantation, thereby allowing primary repair of urethral injuries should they occur, and implantation in the same setting, without a higher risk of infection.
The study will involve 100 male patients undergoing aseptic surgery (regardless the procedure). Patients will be divided into two groups:
Group 1: control group, n=50 Group 2: Chlorhexidine group (Ch group), n=50 Pre-operatively, urethral instillation with Chlorhexidine gel will be performed for the Ch group, while for the control group, instillation will not be performed.
After conclusion of surgery and with the patient on the operative table, the following swabs will be obtained:
- A penile skin swab.
- A urethral swab. Skin and urethral swabs will be compared for bacterial colonization by culture and sensitivity, across the two groups.
详细描述
study design Comparative experimental (interventional) study Sample size
The study will involve 100 male patients undergoing aseptic surgery (regardless the procedure). Patients will be divided into two groups:
Group 1: control group, n=50 Group 2: Chlorhexidine group (Ch group), n=50
Pre-operatively, urethral instillation with Chlorhexidine gel will be performed for the Ch group, while for the control group, instillation will not be performed.
Chlorhexidine gel will be prepared according to an international product; Instillagel®, used prior to urethral catheterization as analgesic / anti-septic, with the following composition:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients aged 20-50 years-old or older undergoing a sterile surgical procedure
排除标准
- •Unwilling patient for this procedure
- •Patients with history of urethral surgery, urinary calculi, urethral structure, or ongoing pyospermia, prostatitis or pyuria will be excluded, and so will be patients undergoing non-sterile surgeries such as abscess drainage.
研究组 & 干预措施
Ch group
Group 2: Chlorhexidine group (Ch group), n=50 Male patients undergoing aseptic surgery (regardless the procedure)
Inclusion criteria Male patients aged 20-50 years-old or older undergoing a sterile surgical procedure.
Exclusion criteria Unwilling patient for this procedure Patients with history of urethral surgery, urinary calculi, urethral structure, or ongoing pyospermia, prostatitis or pyuria will be excluded, and so will be patients undergoing non-sterile surgeries such as abscess drainage.
干预措施: Chlorhexidine gel will be prepared according to an international product Instillagel® (Drug)
结局指标
主要结局
Bacterial colonization by culture and sensitivity
时间窗: 4 days
After conclusion of surgery and with the patient on the operative table, the following swabs will be obtained: * A penile skin swab. * A urethral swab. Skin and urethral swabs will be compared for bacterial colonization by culture and sensitivity, across the two groups.
次要结局
未报告次要终点
研究者
Osama Kamal Shaeer
Professor of Andrology, Sexual Medicine & STDs
Cairo University