Comparing Clean Intermittent Self-catheterization and Indwelling Catheterization for the Manageme… (NCT07555964) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Comparing Clean Intermittent Self-catheterization and Indwelling Catheterization for the Management of Urinary Retention Before BPH Surgery.
France106 participantsStarted 2026-04-24
Plain-language 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.
Who can participate
Age range50 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Occurrence of an infection or infectious complication within 7 days before and 7 days after surgery.
Timeframe: 7 Days before BPH surgery & 7 days after BPH surgery