Comparing Clean Intermittent Self-catheterization and Indwelling Catheterization for the Management of Urinary Retention Before BPH Surgery. (CATHETERS)

University Hospital of Bordeaux

Status: Not yet enrolling

Conditions: Urinary Retention; Surgical Procedures; Urinary Tract Infections; Intermittent Urethral Catheterization; Urinary Catheterization; Prostatic Hyperplasia

Treatments: Procedure: ICSC; Procedure: IDC

Study type: Interventional

Funder types: Other

Identifiers

NCT07555964

CHUBX 2025/20

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 106 estimated patients

Sex: Male

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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106 participants in 2 patient groups

Intermittent Clean Self-Catheterization (ICSC)

Experimental group

Description:

ICSC is a technique of intermittent bladder emptying performed several times a day by the patient themselves.

Treatment:

Procedure: ICSC

Indwelling Catheter (IDC)

Active Comparator group

Description:

IDC is a continuous bladder drainage technique that allows for constant urine removal via a catheter left in place in the bladder.

Treatment:

Procedure: IDC