Does Post-operative Antibiotic Prophylaxis Reduce Urinary Tract Infection Rates After Holmium Laser Enucleation of Prostate? a Prospective Randomized Multi-center Study
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- the rates of urinary tract infection within the 30-day post-operative period after HoLEP
研究概览
简要总结
The purpose of this study is to investigate whether prescribing a 3-day course of antibiotics after Holmium laser enucleation of the prostate (HoLEP) reduces the risk of urinary tract infection. The findings of this trial will have a major impact on clinical practice to either justify the prescription of antibiotics after HoLEP or give urologists more confidence in not prescribing antibiotics prophylactically after HoLEP.
详细描述
Systemic antibiotic usage is the primary driver of antimicrobial resistance both in the index patient and the community. Limiting antibiotic use to indicated patients helps reduction of the risks of antimicrobial overuse, which include associated adverse events, development of multidrug resistant (MDR) organism strains, and increased health-related community burden. (1-3) Holmium laser enucleation of the prostate (HoLEP) has been increasingly used as an effective minimally invasive procedure for the management of enlarged prostate. (4) Most guidelines currently recommend the use of single-dose antibiotic prophylaxis prior to all transurethral procedures for the treatment of benign prostatic hyperplasia including HoLEP. (2,3) Although, most surgeons who perform HoLEP usually extend the antibiotics prophylaxis to 3-7 days or more after HoLEP to avoid the incidence of urinary tract infection. Currently no literature that supports the benefit of prescribing antibiotics routinely to all patients after HoLEP. (5, 6) 2. Significance: This clinical trial will provide insight into the benefit of prescribing antibiotics after HoLEP. This study can be practice-changing for urologists who perform HoLEP as it will decrease the prescription of unnecessary antibiotics. This has major implications for antibiotic stewardship in the field of urology.
3. Objectives & Specific Aims: The purpose of this study is to investigate whether prescribing a 3-day course of antibiotics after HoLEP reduces the risk of urinary tract infection. The findings of this trial will have a major impact on clinical practice to either justify the prescription of antibiotics after HoLEP or give urologists more confidence in not prescribing antibiotics prophylactically after HoLEP.
The specific aims of this study are:
- Avoid the possible unnecessary generalized prolonged antibiotic prophylaxis in patients with HoLEP.
- Identify the patient and procedure factors that increase the incidence of postoperative urinary tract infection.
- Possible selection of patients who can benefit from prolonged antibiotic prophylaxis.
- Help changing the urology practice towards more antibiotic stewardship.
4. Methodology: 4.1 Study Design.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men > 40 years old with moderate to severe lower urinary tract symptoms due to benign prostatic hyperplasia (BPH).
- •Patient with negative preoperative urine culture.
排除标准
- •Patients with history of recurrent urinary tract infection or uro-sepsis.
- •Patient with preoperative infections
- •Patient with indwelling urethral catheter
- •Patient doing continuous intermitted catheterization (CIC)
研究组 & 干预措施
Patients receiving postoperative antibiotics
Patients who will receive3 days prophylactic postoperative antibiotics after HoLEP.
干预措施: Ciprofloxacin (Drug)
Patients not receiving postoperative antibiotics
Patients who will not receive prophylactic postoperative antibiotics after HoLEP.
干预措施: Holmium Laser Enucleation of prostate (Procedure)
Patients receiving postoperative antibiotics
Patients who will receive3 days prophylactic postoperative antibiotics after HoLEP.
干预措施: Nitrofurantoin (Drug)
Patients receiving postoperative antibiotics
Patients who will receive3 days prophylactic postoperative antibiotics after HoLEP.
干预措施: Cephalexin (Drug)
Patients receiving postoperative antibiotics
Patients who will receive3 days prophylactic postoperative antibiotics after HoLEP.
干预措施: Sulfamethoxazole Trimethoprim Combination (Drug)
Patients receiving postoperative antibiotics
Patients who will receive3 days prophylactic postoperative antibiotics after HoLEP.
干预措施: Holmium Laser Enucleation of prostate (Procedure)
结局指标
主要结局
the rates of urinary tract infection within the 30-day post-operative period after HoLEP
时间窗: within 30 days after HoLEP
A urinary tract infection is defined as a positive urine culture .
次要结局
- The incidence of irritative voiding symptoms after HoLEP and all the other urinary functional outcomes.(6 months)
研究者
Marawan M. El Tayeb
Chief, Urology division, BSWH Medical Center, Clinical Associate Professor COM TAMHSC
Baylor Research Institute