Collaborative Urological Prosthetics Investigation Directive Research Group
试验速览
- 阶段
- 早期 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Additional 6 days of oral antibiotics after Penile prothesis placement does not decrease the risk of device infection leading to surgical intervention
研究概览
简要总结
The purpose of this study is to determine if an additional 6 days of oral antibiotics decreases the risk of penile prosthesis infection after implantation.
详细描述
Erectile dysfunction is a common problem and the incidence increases with age. Penile prosthesis placement for medication refractory erectile dysfunction is well established with high success rates. However, infection remains a dreaded complication with significant patient morbidity requiring device explant. Device innovations such as antibiotic coating and adaptations in technique have led to device infection rate reduction to ~1-3% in the hands of high volume implanters in modern series. The study team will perform a non-inferiority trial of post-operative antibiotic prophylaxis for IPP procedures with InhibiZonetm coated AMS 700 devices to confirm the hypothesis that a prolonged postoperative antibiotic regimen does not influence infection-related outcomes in de-novo IPP placement. The study team will determine potential risk factors for prosthetic infections and which patients would benefit from an extended post-operative oral antibiotic course of 6 days along with other objectives.
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
- 35 Years 至 90 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males aged 35 to 90 yo with no racial or ethnic restrictions and a diagnosis of erectile dysfunction.
- •Males clinically indicated for de-novo InhibiZonetm coated AMS 700 devices IPP placement procedure per local clinical guidelines who have elected to pursue penile prosthesis as an ED treatment.
排除标准
- •Patients with indwelling foreign body in the urinary tract > 24 hours prior to the procedure (i.e. foley catheter). Patients using clean intermittent catheterization will not be excluded.
- •Prior history of or current symptomatic urethral stricture.
- •History of cystitis caused by Tuberculosis.
- •Active Cytoxan/cyclophosphamide therapy or immunosuppressive systemic chemotherapy.
- •Prior augmentation cystoplasty or cystectomy.
- •Systemic neuromuscular disease known to affect the lower urinary tract such as Spinal Cord Injury, Multiple Sclerosis or other condition leading to neurogenic bladder.
- •Antibiotic use within the past 1 week or need for antibiotic management immediately prior to the study.
- •Cases where patients have had a prior penile prosthesis.
- •Any protected population (i.e. Prisoners)
研究组 & 干预措施
6 days of oral antibiotics
Patients will receive 24hr of IV peri-operative antibiotics and then 6 days of oral antibiotics
干预措施: Doxycycline (Drug)
6 days of oral antibiotics
Patients will receive 24hr of IV peri-operative antibiotics and then 6 days of oral antibiotics
干预措施: Ciprofloxacin (Drug)
6 days of oral antibiotics
Patients will receive 24hr of IV peri-operative antibiotics and then 6 days of oral antibiotics
干预措施: Augmentin (Drug)
6 days of oral antibiotics
Patients will receive 24hr of IV peri-operative antibiotics and then 6 days of oral antibiotics
干预措施: Bactrim (Drug)
No post-operative oral antibiotics
Patients will only receive 24hr of IV peri-operative antibiotics
结局指标
主要结局
Additional 6 days of oral antibiotics after Penile prothesis placement does not decrease the risk of device infection leading to surgical intervention
时间窗: 12 months
From day of surgery through 1 year we are hoping to show that additional 6 days of oral antibiotics do not decrease the risk of penile prosthesis infection requiring surgical intervention for device removal.
次要结局
- Additional 6 days of oral antibiotics after Penile prosthesis placement does not decrease the risk of superficial tissue infections after penile prothesis implantation.(12 months)