Comparing Clean Intermittent Self-catheterization and Indwelling Catheterization for the Management of Urinary Retention Before BPH Surgery.l
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 106
- 试验地点
- 5
- 主要终点
- Occurrence of an infection or infectious complication within 7 days before and 7 days after surgery.
研究概览
简要总结
The CATHETERS trial is a multicenter, randomized, open-label superiority study comparing two methods of managing urinary retention before surgery for benign prostatic hyperplasia (BPH): clean intermittent self-catheterization (ICSC) versus indwelling catheter (IDC). The primary objective is to determine whether ICSC reduces the occurrence of infectious complications (urinary bacterial colonization requiring antibiotic therapy, urinary tract infection, or urosepsis) compared to IDC in men awaiting BPH surgery. A total of 106 patients will be enrolled across multiple centers in France, with follow-up extending to three months after surgery.
详细描述
Acute urinary retention (AUR) is a frequent complication of benign prostatic hyperplasia (BPH), a condition highly prevalent in older men. The standard management of AUR involves placement of an indwelling catheter (IDC) until surgical treatment can be performed. However, the presence of an IDC is associated with inevitable bacterial colonization of the urinary tract, with the risk increasing by 5-10% per day and reaching 100% after one month. This colonization leads to a higher rate of perioperative infectious complications, increased antibiotic consumption, and prolonged hospitalization. Preliminary retrospective data from our team, comparing 31 ICSC patients to 28 IDC patients, demonstrated significant advantages of ICSC: shorter postoperative catheterization (1 vs. 2.5 days; p < 0.001), better spontaneous voiding recovery (93.5% vs. 64.3%; p < 0.001), less bacterial colonization (51.6% vs. 100%; p < 0.001), and fewer postoperative complications (13% vs. 50%; p < 0.001). Despite these promising results, no randomized trial has been conducted to confirm these findings. This is a multicenter, randomized, open-label, two-arm superiority trial. Eligible patients with AUR due to BPH who fail catheter weaning despite alpha-blocker therapy are randomized to either ICSC (Arm A) or IDC (Arm B) while awaiting BPH surgery. Follow-up includes preoperative assessments, perioperative data collection including urine cultures and antibiotic use within seven days before and after surgery, a telephone consultation at one month, and a final in-person evaluation at three months post-surgery to assess voiding recovery, complications, quality of life, and hospitalization duration.
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
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men over 50 years old;
- •Confirmed diagnosis of benign prostatic hyperplasia (BPH);
- •Prostate volume greater than 40 grams;
- •Presence of acute urinary retention with failure to wean from the catheter despite medical treatment with alpha-blocker for at least 48 hours
- •Indication for surgical management of BPH;
- •Patient affiliated with or a beneficiary of a social security scheme;
- •Signed informed consent for participation in the study.
排除标准
- •Patient with a history of prostate surgery (including BPH surgery), prostatic artery embolization or Urolift implant placement are not considered a history of prostate surgery;
- •Patient with symptomatic urethral stricture;
- •Patient with a bladder emptying disorder of neurogenic origin;
- •Patient with an anatomical contraindication to ICSC (urethral stricture, false urethral route);
- •Patient who had urine drainage by suprapubic catheter
- •Patient with motor, neurological, anatomical, or cognitive difficulties preventing the education or learning of ICSC;
- •Patient contraindicated for surgical management of their BPH;
- •Patient unable to understand the research documents and provide informed consent;
- •Persons subject to legal protection measures or placed under judicial protection.
研究组 & 干预措施
Intermittent Clean Self-Catheterization (ICSC)
ICSC is a technique of intermittent bladder emptying performed several times a day by the patient themselves.
干预措施: ICSC (Procedure)
Indwelling Catheter (IDC)
IDC is a continuous bladder drainage technique that allows for constant urine removal via a catheter left in place in the bladder.
干预措施: IDC (Procedure)
结局指标
主要结局
Occurrence of an infection or infectious complication within 7 days before and 7 days after surgery.
时间窗: 7 Days before BPH surgery & 7 days after BPH surgery
Evaluation of the occurrence of an infection or infectious complication within 7 days before and after surgery (including urinary bacterial colonization requiring antibiotic therapy, urinary tract infection, or urosepsis), assessed during the perioperative period (7 days before to 7 days after BPH surgery).
次要结局
- Rate of postoperative complications according to the Clavien-Dindo classification(1 Month & 3 Months)
- Duration of postoperative catheterization(From the date of BPH surgery to the date of definitive catheter removal, assessed up to 30 days post-surgery)
- Duration of postoperative hospitalization(From the date of BPH surgery to the date of hospital discharge, assessed up to 30 days post-surgery)
- Rate of successful spontaneous voiding recovery(At hospital discharge, assessed up to 7 days post-surgery)
- Patient quality of life (1)(Baseline; 1 month post surgery; 3 Months post-surgery)
- Patient quality of life (2)(Baseline; 1 month post surgery; 3 Months post-surgery)
- Patient quality of life (3)(Baseline; 1 month post surgery; 3 Months post-surgery)
- 30-day readmission rate, defined as the percentage of randomized patients in each group readmitted to hospital within 30 days after surgery(1 month post surgery)
- ICSC learning success rate(within 3 months before surgery)