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ClinicalTrials.gov ID

NCT07555964

Lead Sponsor

University Hospital, BordeauxOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

106Estimated

Last Update Posted

Apr 29, 2026Actual

Start Date

Apr 24, 2026Estimated

Primary Completion Date

Apr 24, 2028Estimated

Completion Date

Apr 24, 2028Estimated

Official Title

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

Brief Summary

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.

Detailed 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.

• Prostatic Hyperplasia
• Urinary Retention
• Urinary Catheterization
• Intermittent Urethral Catheterization
• Urinary Tract Infections
• Surgical Procedures

• ICSC
• IDC

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

Male

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Single

Lead Sponsor

University Hospital, BordeauxOTHER

clement.michiels@gmail.com0033 5 56 11 61 44

ugo.pinar@aphp.fr0033 1 84 82 80 63

richard.mallet1@gmail.com0033 6 22 47 16 45

game.x@chu-toulouse.fr0033 5 61 32 31 06