ICSC: ICSC consists of temporary urinary drainage performed by the patient themselves, following therapeutic education provided by a trained nurse. Patients use sterile, single-use catheters to empty their bladder 5 to 6 times a day. This method reduces the risk of infectious complications associated with indwelling catheters, while maintaining a good level of patient autonomy and a satisfactory quality of life. The necessary equipment is provided, and regular follow-ups are organised to monitor the tolerance and effectiveness of the procedure.
IDC: IDC involves inserting a urinary catheter connected to a continuous drainage system, which is left in place until surgery. The method is simple to perform and widely used in cases of acute urinary retention. However, it is associated with an increased risk of bacterial colonisation and urinary tract infections, particularly when the catheter is left in place for a prolonged period.
Study 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.
Eligibility
Sex
MALE
Min age
50 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)
Occurrence of an infection or infectious complication within 7 days before and 7 days after surgery. — 7 Days before BPH surgery & 7 days after BPH surgery Evaluation of the occurrence of an infection or infectious complication within 7 days before and after surgery (including urinary bacterial colonization requiring antibiotic therapy, urinary tract infection, or urosepsis), assessed during the perioperative period (7 days before to 7 days after BPH surgery).
Trial sites (5)
Facility
City
Region
Status
CHU d'Angers
Angers
France
Centre d'Urologie Bordeaux Saint Gatien
Bourdeaux
France
APHP la Pitié-Salpêtrière
Paris
France
Hôpital Prive Francheville
Périgueux
France
CHU de Toulouse Rangueil
Toulouse
France
More University Hospital, Bordeaux trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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