About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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);
Trial design
Treatments tested in this trial
- ICSC
- IDC