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 range
50 Years
Sex
MALE
See this in plain English?
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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